1) A study evaluated a novel closed-loop gastric electrical stimulation system called abiliti for treating obesity. 34 obese participants were implanted with the device.
2) At 12 months, participants experienced a mean excess weight loss of 28.7% and a mean BMI reduction of 4.8 kg/m2. Weight loss was stable through 27 months for those who remained in follow up.
3) The device led to significant alterations in eating behavior including reduced disinhibition and hunger, and increased physical activity and cognition around eating. The gastric electrical stimulation treatment was well tolerated and resulted in significant weight loss and behavioral changes.
EFFECTIVENESS OF ADJUVANT YOGA THERAPY IN DIABETIC LUNG: A RANDOMIZED CONTROL...Yogacharya AB Bhavanani
EFFECTIVENESS OF ADJUVANT YOGA THERAPY IN DIABETIC LUNG: A RANDOMIZED CONTROL TRIAL
Balaji Rajasekaran1, Ananda Balayogi Bhavanani2, Meena Ramanathan3
1 Assistant Professor, Centre for Yogic sciences, Aarupadai Veedu Medical Colleges, Vinayaka Missions Research Foundation, Pondicherry
2 & 3 Director and Deputy Director, Centre for Yoga Therapy, Education and Research, Sri Balaji Vidyapeeth, Pondicherry.
E-mail of presenter: balaji.rajasekaran@avmc.edu.in
Abstract:
Context: Recent studies provide ample evidence of the benefits of yoga in various chronic disorders. Diabetes mellitus is a group of metabolic diseases characterized by chronic hyperglycemia and Sandler coined the term “Diabetic Lung" for the abnormal pulmonary function detected in diabetic patients due underlying pulmonary dysfunction. Yoga therapy may help in achieving better pulmonary function along with enhanced glycaemic control and overall health benefits.
Aim: To study the effect of adjuvant yoga therapy in diabetic lung through spirometry.
Settings and Design: Randomized control trial done as interdisciplinary collaborative work between Yoga Therapy, Pulmonary Medicine and Endocrinology departments of MGMC & RI, Sri Balaji Vidyapeeth Puducherry.
Materials and Methods: 72 patients of diabetic lung as confirmed by spirometry (<70% of expected) were randomized and divided equally into control group who received only standard medical treatment and yoga group who received yoga training thrice weekly for 4 months along with that. Yoga therapy protocol included yogic counseling, preparatory practices, Asanas or static postures, Pranayama or breathing techniques and relaxation techniques. Hathenas of the Gitananda Yoga tradition were the main practices used. Spirometry was done at the end of the study period. Data was analyzed by Student’s paired and unpaired ’t’ test as it passed normality.
Results: There was a statistically significant (p < 0.05) reduction in weight, BMI along with a significant (p < 0.01) improvement in pulmonary function (FEV1, FVC) in yoga group as compared to control group where parameters worsened over study period.
Conclusion: It is concluded from the present RCT that yoga has a definite role as an adjuvant therapy as it enhances standard medical care and hence is even more significant in routine clinical management of diabetes, improving physical condition and pulmonary function.
Key words: diabetic lung, PFT, hathenas, yoga therapy
Effect of Inspiratory Muscle Training on Muscle Strength and Quality of Life ...kacm20
Effect of Inspiratory Muscle Training on Muscle Strength and
Quality of Life in Patients With Chronic Airflow Limitation:
a Randomized Controlled Trial
Pulmonary Rehab: impact on lung function and breathlessnessSubodh Gupta
This presentation is for patient education so that they can make informed choices while evaluating options for post COVID recovery or any other lung disease. This is specially meant for caretakers whose patients suffer from breathing issues or are on supplemental oxygen (oxygen concentrator or oxygen cylinder).
This explains how RespiRehab works and helps patients recover.
Hypothyroidism in association with obesity, the most common endocrine disorder among females in urban areas. The objective is to find out the effect of yoga intervention on hypothyroidism linked with obesity among working women leading sedentary lifestyles in urban areas. Further to assess the recovery through yoga practice in addition to diet follow up treated as safe, very low cost, natural therapy. A total of 150 obese women had a history of hypothyroidism within the age group 30-50 years located in eastern parts of West Bengal were enrolled for this study from June,17 to January, 18. A qualitative study by a purposive sampling method was used applying BMI as the main parameter along with questionnaires & thyroid function tests, blood tests as secondary data. The study revealed initially that there was no such deficiency of nutrients like Iodine even though elevated TSH & normal or low T4 among the subjects. The study concluded that diet in conjunction with yoga intervention resulted in significant improvement to all subjects at no cost. Moreover, yoga intervention was the safest choice for all of them in this study and that not only for physical health but also mental wellbeing.
EFFECTIVENESS OF ADJUVANT YOGA THERAPY IN DIABETIC LUNG: A RANDOMIZED CONTROL...Yogacharya AB Bhavanani
EFFECTIVENESS OF ADJUVANT YOGA THERAPY IN DIABETIC LUNG: A RANDOMIZED CONTROL TRIAL
Balaji Rajasekaran1, Ananda Balayogi Bhavanani2, Meena Ramanathan3
1 Assistant Professor, Centre for Yogic sciences, Aarupadai Veedu Medical Colleges, Vinayaka Missions Research Foundation, Pondicherry
2 & 3 Director and Deputy Director, Centre for Yoga Therapy, Education and Research, Sri Balaji Vidyapeeth, Pondicherry.
E-mail of presenter: balaji.rajasekaran@avmc.edu.in
Abstract:
Context: Recent studies provide ample evidence of the benefits of yoga in various chronic disorders. Diabetes mellitus is a group of metabolic diseases characterized by chronic hyperglycemia and Sandler coined the term “Diabetic Lung" for the abnormal pulmonary function detected in diabetic patients due underlying pulmonary dysfunction. Yoga therapy may help in achieving better pulmonary function along with enhanced glycaemic control and overall health benefits.
Aim: To study the effect of adjuvant yoga therapy in diabetic lung through spirometry.
Settings and Design: Randomized control trial done as interdisciplinary collaborative work between Yoga Therapy, Pulmonary Medicine and Endocrinology departments of MGMC & RI, Sri Balaji Vidyapeeth Puducherry.
Materials and Methods: 72 patients of diabetic lung as confirmed by spirometry (<70% of expected) were randomized and divided equally into control group who received only standard medical treatment and yoga group who received yoga training thrice weekly for 4 months along with that. Yoga therapy protocol included yogic counseling, preparatory practices, Asanas or static postures, Pranayama or breathing techniques and relaxation techniques. Hathenas of the Gitananda Yoga tradition were the main practices used. Spirometry was done at the end of the study period. Data was analyzed by Student’s paired and unpaired ’t’ test as it passed normality.
Results: There was a statistically significant (p < 0.05) reduction in weight, BMI along with a significant (p < 0.01) improvement in pulmonary function (FEV1, FVC) in yoga group as compared to control group where parameters worsened over study period.
Conclusion: It is concluded from the present RCT that yoga has a definite role as an adjuvant therapy as it enhances standard medical care and hence is even more significant in routine clinical management of diabetes, improving physical condition and pulmonary function.
Key words: diabetic lung, PFT, hathenas, yoga therapy
Effect of Inspiratory Muscle Training on Muscle Strength and Quality of Life ...kacm20
Effect of Inspiratory Muscle Training on Muscle Strength and
Quality of Life in Patients With Chronic Airflow Limitation:
a Randomized Controlled Trial
Pulmonary Rehab: impact on lung function and breathlessnessSubodh Gupta
This presentation is for patient education so that they can make informed choices while evaluating options for post COVID recovery or any other lung disease. This is specially meant for caretakers whose patients suffer from breathing issues or are on supplemental oxygen (oxygen concentrator or oxygen cylinder).
This explains how RespiRehab works and helps patients recover.
Hypothyroidism in association with obesity, the most common endocrine disorder among females in urban areas. The objective is to find out the effect of yoga intervention on hypothyroidism linked with obesity among working women leading sedentary lifestyles in urban areas. Further to assess the recovery through yoga practice in addition to diet follow up treated as safe, very low cost, natural therapy. A total of 150 obese women had a history of hypothyroidism within the age group 30-50 years located in eastern parts of West Bengal were enrolled for this study from June,17 to January, 18. A qualitative study by a purposive sampling method was used applying BMI as the main parameter along with questionnaires & thyroid function tests, blood tests as secondary data. The study revealed initially that there was no such deficiency of nutrients like Iodine even though elevated TSH & normal or low T4 among the subjects. The study concluded that diet in conjunction with yoga intervention resulted in significant improvement to all subjects at no cost. Moreover, yoga intervention was the safest choice for all of them in this study and that not only for physical health but also mental wellbeing.
Pulmonary rehab is part of global standard of care for patients suffering from chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), persistent bronchial asthma and other lung manifestations.
Respirehab makes pulmonary rehab accessible, convenient and cost effective by taking it digital & online.
A Quasi Experimental Study to Assess the Effectiveness of Selected Nursing In...iosrjce
A study to assess the effectiveness of selected nursing interventions on health related quality of life
and activities of daily living among COPD patients in selected tertiary hospital, Chennai, Tamilnadu, India.
The aim of the study was to impart the selected nursing interventions applied to the COPD patients in medical
and pulmonary wards. The conceptual framework used in this study was Widenbach’s Helping art Theory. An
Evaluative approach was used for the present study. Using purposive sampling technique 50 samples were
selected from Chettinad Hospital and Research Institute, Tamil Nadu, India. The tool used was self
administered questionnaire. The collected data was analyzed using descriptive and inferential statistics. The
findings of the study revealed a significantly increase in the COPD patients health related quality of life and
activities of daily living after given the selected nursing interventions. The mean pre test score was 1867 and
the mean post test score was 1861 and the difference between pre test and post test knowledge score was 5.54.
Based on the objectives of the study the findings of the level of health related quality of life and activities of
daily living among COPD patients shows that increased health related quality of life and activities of daily
living. The study shows that the COPD patients in post test were having post score1861 mean difference
5.54.standard deviation 2.35.p value (0.02). Selected nursing interventions are effective in increasing the health
related qualityof life and activities of daily living among COPD patients.. The findings of the study revealed that
a significantly increased in the post test health related quality of life and activities of daily living after given the
selected nursing interventions
Objective: To assess the effect of a kinesitherapeutic
program of special exercises for treatment of pain intensity and
endurance of the extensor trunk muscles in patients with
chronic lumbalgy.
Methods: The study included 110 patients with chronic
lumbalgy, equally distributed in two treatment groups.
Participants in the experimental group performed the
recommended special exercises 3 times a week at home, while
those in the control group only followed the guidelines of a
physician. At the beginning of the study and 12 months later,
the pain intensity of all the participants was assessed by means
of Visual Analog Scale.
Results: In contrast to the participants in the control
group, those in the experimental group at the end of observation
were reported to experience a significant reduction in pain
intensity.
Conclusions: Treatment with specific exercises proved
more effective in terms of pain complaints in patients with
chronic lumbalgy.
Effect of yogic practices on the selected physiological variables among the m...Sports Journal
The present study is to analyze the effect of Yogic practices on the selected physiological variables
among the middle aged men. For this study 100 middle age male persons were selected from Yazh Yoga
Coimbatore city, after the scrutiny by the scholar and experts 30 middle aged men were selected as
subjects by adopting purposive random sampling technique. The age of the subjects ranged from 35 to 45
years. They were divided into two equal groups namely, the group were assigned Asana, Pranayama,
Meditation (APMTG) and Control group (CG). The subjects were tested to find out the Resting Pulse
Rate, Vital Capacity and Blood Pressure. The pulse rate was assessed by arterial pulse, vital capacity was
measured by digital Spiro meter and blood pressure was measured by sphygmomanometer. The Asana,
Pranayama, Meditation(APMTG) Yoga group participated in Yogic practices for a period of twelve
weeks and control group did not participate in any special practice. The data were collected before and
after the training period and the pretest, post-test and the adjusted post-test were analyzed by Analysis of
Covariance (ANCOVA). The level of significance for the study was chosen as 0.05. It is concluded from
the results that the APMTG group has significant improvement in resting pulse rate, vital capacity and
blood pressure among middle aged men.
Comparative effect of 12 weeks of slow and fast pranayama training on pulmona...Yogacharya AB Bhavanani
Comparative effect of 12 weeks of slow and fast pranayama training on pulmonary function in young, healthy volunteers: A randomized controlled trial
T Dinesh, GS Gaur, VK Sharma, T Madanmohan, KT Harichandra Kumar, AB Bhavanani
Abstract
Context: Pranayamas are breathing techniques that exert profound physiological effects on pulmonary, cardiovascular, and mental functions. Previous studies demonstrate that different types of pranayamas produce divergent effects.
Aim: The aim was to compare the effect of 12 weeks of slow and fast pranayama training on pulmonary function in young, healthy volunteers.
Settings and Design: This study was carried out in Departments of Physiology and ACYTER, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry in 2011.
Subjects and Methods: Ninety one healthy volunteers were randomized into slow pranayama group (SPG), n =29, fast pranayama group (FPG), n = 32 and control groups (CG) (n = 30). Supervised pranayama training (SPG: Nadisodhana, Pranav pranayama and Savitri pranayama; FPG: Kapalabhati, Bhastrika and Kukkriya pranayama) was given for 30 min/day, thrice/week for 12 weeks by certified yoga instructors. Pulmonary function parameters (PFT) such as forced vital capacity (FVC), forced expiratory volume in first second (FEV 1 ), ratio between FEV 1 and FVC (FEV 1 /FVC), peak expiratory flow rate (PEFR), maximum voluntary ventilation (MVV), and forced expiratory flow 25-75 (FEF 25-75 ), were recorded at baseline and after 12 weeks of pranayama training using the computerized spirometer (Micro laboratory V1.32, England).
Results: In SPG, PEFR, and FEF 25-75 improved significantly (P < 0.05) while other parameters (FVC, FEV 1 , FEV 1 /FVC, and MVV) showed only marginal improvements. In FPG, FEV 1 /FVC, PEFR, and FEF 25-75 parameters improved significantly (P < 0.05), while FVC, FEV 1 , and MVV did not show significant (P > 0.05) change. No significant change was observed in CG.
Conclusion: Twelve weeks of pranayama training in young subjects showed improvement in the commonly measured PFT. This indicates that pranayama training improved pulmonary function and that this was more pronounced in the FPG.
IOSR Journal of Humanities and Social Science is an International Journal edited by International Organization of Scientific Research (IOSR).The Journal provides a common forum where all aspects of humanities and social sciences are presented. IOSR-JHSS publishes original papers, review papers, conceptual framework, analytical and simulation models, case studies, empirical research, technical notes etc.
Evaluvation of Perioperative Haemodynamic Changes in Hypertensive Patients Tr...iosrjce
IOSR Journal of Dental and Medical Sciences is one of the speciality Journal in Dental Science and Medical Science published by International Organization of Scientific Research (IOSR). The Journal publishes papers of the highest scientific merit and widest possible scope work in all areas related to medical and dental science. The Journal welcome review articles, leading medical and clinical research articles, technical notes, case reports and others.
DIAPHRAGMATIC MUSCLE SONOGRAPHY IN THE PHYSIOTHERAPIST CLINICAL PRACTICE AS ...Angelo Longoni
The aim of this work is to describe how the Ultrasound of the diaphragm muscle can be useful in the clinical practice of the physiotherapist as a support to the classical clinical tests such as wt 6 minutes and MIP/MEP pressures, after a rehabilitation program in COPD patients.
Diabetic Peripheral Neuropathy- 6 Months Follow up Using Resisted Exercises a...inventionjournals
Introduction: An alarming global increase in type 2 diabetes, with second maximum known diabetic subjects in India, peripheral neuropathy which remain unfocussed with complications such as falls, ulcers, amputation, decreased mobility, dependence for ADL and disability associated along with. Aims and Objectives of This Research: To analyse obesity, glycemic control and neuropathy on a diabetic subject. Materials and Methodology: This original study was on a subject for 30 years with known type 2 diabetes and for 10 years with peripheral neuropathy, where the impact of resisted exercises and Proprioceptive training were analysed for 6 months period from October 2016 to March 2017. Results: A marginal reduction in obesity and improved glycemic control by 0.5% and slight lowering of Toronto clinical scoring system for diabetic neuropathy were recorded. Conclusion: The findings of this study could implicate benefits of larger population in the society as nearly 50% of diabetic develop neuropathy. Also this was an innovative and first research study among diabetic neuropathy subjects using RET and proprioceptive exercises. Key Words: HbA1C – Glycosylated Hemoglobin, IDF - International Diabetes Federation, TCSS - Toronto clinical scoring system, BMI – Body Mass Index, WC – Waist Circumference, UKPDS – United Kingdom Prospective Diabetes Study, NCV – Nerve Conduction Velocity, ACSM – American College of Sports Medicine, TENS – Transcutaneous Electrical Nerve Stimulation, VAS – Visual Analogue Scale, ADL – Activities of Daily Life
Pulmonary rehab is part of global standard of care for patients suffering from chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), persistent bronchial asthma and other lung manifestations.
Respirehab makes pulmonary rehab accessible, convenient and cost effective by taking it digital & online.
A Quasi Experimental Study to Assess the Effectiveness of Selected Nursing In...iosrjce
A study to assess the effectiveness of selected nursing interventions on health related quality of life
and activities of daily living among COPD patients in selected tertiary hospital, Chennai, Tamilnadu, India.
The aim of the study was to impart the selected nursing interventions applied to the COPD patients in medical
and pulmonary wards. The conceptual framework used in this study was Widenbach’s Helping art Theory. An
Evaluative approach was used for the present study. Using purposive sampling technique 50 samples were
selected from Chettinad Hospital and Research Institute, Tamil Nadu, India. The tool used was self
administered questionnaire. The collected data was analyzed using descriptive and inferential statistics. The
findings of the study revealed a significantly increase in the COPD patients health related quality of life and
activities of daily living after given the selected nursing interventions. The mean pre test score was 1867 and
the mean post test score was 1861 and the difference between pre test and post test knowledge score was 5.54.
Based on the objectives of the study the findings of the level of health related quality of life and activities of
daily living among COPD patients shows that increased health related quality of life and activities of daily
living. The study shows that the COPD patients in post test were having post score1861 mean difference
5.54.standard deviation 2.35.p value (0.02). Selected nursing interventions are effective in increasing the health
related qualityof life and activities of daily living among COPD patients.. The findings of the study revealed that
a significantly increased in the post test health related quality of life and activities of daily living after given the
selected nursing interventions
Objective: To assess the effect of a kinesitherapeutic
program of special exercises for treatment of pain intensity and
endurance of the extensor trunk muscles in patients with
chronic lumbalgy.
Methods: The study included 110 patients with chronic
lumbalgy, equally distributed in two treatment groups.
Participants in the experimental group performed the
recommended special exercises 3 times a week at home, while
those in the control group only followed the guidelines of a
physician. At the beginning of the study and 12 months later,
the pain intensity of all the participants was assessed by means
of Visual Analog Scale.
Results: In contrast to the participants in the control
group, those in the experimental group at the end of observation
were reported to experience a significant reduction in pain
intensity.
Conclusions: Treatment with specific exercises proved
more effective in terms of pain complaints in patients with
chronic lumbalgy.
Effect of yogic practices on the selected physiological variables among the m...Sports Journal
The present study is to analyze the effect of Yogic practices on the selected physiological variables
among the middle aged men. For this study 100 middle age male persons were selected from Yazh Yoga
Coimbatore city, after the scrutiny by the scholar and experts 30 middle aged men were selected as
subjects by adopting purposive random sampling technique. The age of the subjects ranged from 35 to 45
years. They were divided into two equal groups namely, the group were assigned Asana, Pranayama,
Meditation (APMTG) and Control group (CG). The subjects were tested to find out the Resting Pulse
Rate, Vital Capacity and Blood Pressure. The pulse rate was assessed by arterial pulse, vital capacity was
measured by digital Spiro meter and blood pressure was measured by sphygmomanometer. The Asana,
Pranayama, Meditation(APMTG) Yoga group participated in Yogic practices for a period of twelve
weeks and control group did not participate in any special practice. The data were collected before and
after the training period and the pretest, post-test and the adjusted post-test were analyzed by Analysis of
Covariance (ANCOVA). The level of significance for the study was chosen as 0.05. It is concluded from
the results that the APMTG group has significant improvement in resting pulse rate, vital capacity and
blood pressure among middle aged men.
Comparative effect of 12 weeks of slow and fast pranayama training on pulmona...Yogacharya AB Bhavanani
Comparative effect of 12 weeks of slow and fast pranayama training on pulmonary function in young, healthy volunteers: A randomized controlled trial
T Dinesh, GS Gaur, VK Sharma, T Madanmohan, KT Harichandra Kumar, AB Bhavanani
Abstract
Context: Pranayamas are breathing techniques that exert profound physiological effects on pulmonary, cardiovascular, and mental functions. Previous studies demonstrate that different types of pranayamas produce divergent effects.
Aim: The aim was to compare the effect of 12 weeks of slow and fast pranayama training on pulmonary function in young, healthy volunteers.
Settings and Design: This study was carried out in Departments of Physiology and ACYTER, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry in 2011.
Subjects and Methods: Ninety one healthy volunteers were randomized into slow pranayama group (SPG), n =29, fast pranayama group (FPG), n = 32 and control groups (CG) (n = 30). Supervised pranayama training (SPG: Nadisodhana, Pranav pranayama and Savitri pranayama; FPG: Kapalabhati, Bhastrika and Kukkriya pranayama) was given for 30 min/day, thrice/week for 12 weeks by certified yoga instructors. Pulmonary function parameters (PFT) such as forced vital capacity (FVC), forced expiratory volume in first second (FEV 1 ), ratio between FEV 1 and FVC (FEV 1 /FVC), peak expiratory flow rate (PEFR), maximum voluntary ventilation (MVV), and forced expiratory flow 25-75 (FEF 25-75 ), were recorded at baseline and after 12 weeks of pranayama training using the computerized spirometer (Micro laboratory V1.32, England).
Results: In SPG, PEFR, and FEF 25-75 improved significantly (P < 0.05) while other parameters (FVC, FEV 1 , FEV 1 /FVC, and MVV) showed only marginal improvements. In FPG, FEV 1 /FVC, PEFR, and FEF 25-75 parameters improved significantly (P < 0.05), while FVC, FEV 1 , and MVV did not show significant (P > 0.05) change. No significant change was observed in CG.
Conclusion: Twelve weeks of pranayama training in young subjects showed improvement in the commonly measured PFT. This indicates that pranayama training improved pulmonary function and that this was more pronounced in the FPG.
IOSR Journal of Humanities and Social Science is an International Journal edited by International Organization of Scientific Research (IOSR).The Journal provides a common forum where all aspects of humanities and social sciences are presented. IOSR-JHSS publishes original papers, review papers, conceptual framework, analytical and simulation models, case studies, empirical research, technical notes etc.
Evaluvation of Perioperative Haemodynamic Changes in Hypertensive Patients Tr...iosrjce
IOSR Journal of Dental and Medical Sciences is one of the speciality Journal in Dental Science and Medical Science published by International Organization of Scientific Research (IOSR). The Journal publishes papers of the highest scientific merit and widest possible scope work in all areas related to medical and dental science. The Journal welcome review articles, leading medical and clinical research articles, technical notes, case reports and others.
DIAPHRAGMATIC MUSCLE SONOGRAPHY IN THE PHYSIOTHERAPIST CLINICAL PRACTICE AS ...Angelo Longoni
The aim of this work is to describe how the Ultrasound of the diaphragm muscle can be useful in the clinical practice of the physiotherapist as a support to the classical clinical tests such as wt 6 minutes and MIP/MEP pressures, after a rehabilitation program in COPD patients.
Diabetic Peripheral Neuropathy- 6 Months Follow up Using Resisted Exercises a...inventionjournals
Introduction: An alarming global increase in type 2 diabetes, with second maximum known diabetic subjects in India, peripheral neuropathy which remain unfocussed with complications such as falls, ulcers, amputation, decreased mobility, dependence for ADL and disability associated along with. Aims and Objectives of This Research: To analyse obesity, glycemic control and neuropathy on a diabetic subject. Materials and Methodology: This original study was on a subject for 30 years with known type 2 diabetes and for 10 years with peripheral neuropathy, where the impact of resisted exercises and Proprioceptive training were analysed for 6 months period from October 2016 to March 2017. Results: A marginal reduction in obesity and improved glycemic control by 0.5% and slight lowering of Toronto clinical scoring system for diabetic neuropathy were recorded. Conclusion: The findings of this study could implicate benefits of larger population in the society as nearly 50% of diabetic develop neuropathy. Also this was an innovative and first research study among diabetic neuropathy subjects using RET and proprioceptive exercises. Key Words: HbA1C – Glycosylated Hemoglobin, IDF - International Diabetes Federation, TCSS - Toronto clinical scoring system, BMI – Body Mass Index, WC – Waist Circumference, UKPDS – United Kingdom Prospective Diabetes Study, NCV – Nerve Conduction Velocity, ACSM – American College of Sports Medicine, TENS – Transcutaneous Electrical Nerve Stimulation, VAS – Visual Analogue Scale, ADL – Activities of Daily Life
Diabetic Peripheral Neuropathy- 6 Months Follow up Using Resisted Exercises a...
Similar to Horbach - 2015 - abiliti closed-loop gastric electrical stimulation system for treatment of obesity - clinical results with a 27 month follow-up
Journal Presentation on article Comparative efficacy of different combination...Shubham Jain
Journal Presentation on article Comparative efficacy of different combinations of acapella, active cycle of breathing technique, and external diaphragmatic pacing in perioperative patients with lung cancer
RESEARCH Open AccessTelecoaching plus a portion control pl.docxsyreetamacaulay
RESEARCH Open Access
Telecoaching plus a portion control plate
for weight care management: a
randomized trial
Jill M. Huber1, Joshua S. Shapiro2, Mark L. Wieland1, Ivana T. Croghan1, Kristen S. Vickers Douglas3,
Darrell R. Schroeder4, Julie C. Hathaway5 and Jon O. Ebbert1,6*
Abstract
Background: Obesity is a leading preventable cause of death and disability and is associated with a lower health-
related quality of life. We evaluated the impact of telecoaching conducted by a counselor trained in motivational
interviewing paired with a portion control plate for obese patients in a primary care setting.
Methods: We conducted a randomized, clinical trial among patients in a primary care practice in the midwestern
United States. Patients were randomized to either usual care or an intervention including telecoaching with a
portion control plate. The intervention was provided during a 3-month period with follow-up of all patients
through 6 months after randomization. The primary outcomes were weight, body mass index (BMI),waist
circumference, and waist to hip ratio measured at baseline, 6, 12, 18, and 24 weeks. Secondary outcomes included
measures assessing eating behaviors, self-efficacy, and physical activity at baseline and at 12 and 24 weeks.
Results: A total of 1,101 subjects were pre-screened, and 90 were randomly assigned to telecoaching plus portion
control plate (n = 45) or usual care (n = 45). Using last-value carried forward without adjustment for baseline
demographics, significant reductions in BMI (estimated treatment effect -0.4 kg/m2, P = .038) and waist to hip ratio
(estimated treatment effect -.02, P = .037) at 3 months were observed in the telecoaching plus portion control plate
group compared to usual care. These differences were not statistically significant at 6 months. In females, the
telecoaching plus portion control plate intervention was associated with significant reductions in weight and BMI
at both 3 months (estimated treatment effect -1.6 kg, P = .016 and -0.6 kg/m2, P = .020) and 6 months (estimated
treatment effect -2.3 kg, P = .013 and -0.8 kg/m2, P = .025). In males, the telecoaching plus portion control
intervention was associated with a significant reduction in waist to hip ratio at 3 months (estimated treatment
effect -0.04, P = .017), but failed to show a significant difference in weight and BMI.
Conclusion: Telecoaching with a portion control plate can produce positive change in body habitus among obese
primary care patients; however, changes depend upon sex.
Trial registration: ClinicalTrials.gov NCT02373878, 13 February 2015. https://clinicaltrials.gov/ct2/show/
NCT02373878.
Keywords: Obesity, Telecoaching, Portion control plate, Primary care, Patient-centered medical home
* Correspondence: [email protected]
1Division of Primary Care Internal Medicine, Department of Medicine,
Rochester, MN 55905, USA
6Mayo Clinic, 200 First Street Southwest, Rochester, MN 55905, USA
Full list of author information is ...
Globally 165 million children under-five
years of age are stunted. Hence development of local
therapeutic nutritional intervention is recommended by WHO.
Present study was designed to find the efficacy of the
nutritional intervention for the recovery of impaired lipid
metabolism and correlation of weight for height% with
cholesterol, triglyceride in malnourished children. 105 test and
100 control SAM children without infection, of 1 to 5 years of
age and either sex were enrolled. Test group was given
treatment of nutritional intervention therapy, providing 2.5 to
3gm Protein and 90-100 kcal /kg body Weight/day, for the
three months. Their Anthropometric, and Biochemical
parameters were measured before and after the nutritional
therapy. Before the nutritional intervention treatment P values
for Serum Total cholesterol, Triglyceride, Weight for height
%, were insignificant suggestive of similar baseline
characteristics at enrollment. After nutritional intervention
treatment P values for Serum Total cholesterol, Triglyceride,
Weight for height % were highly significant. The r value of
Pearson correlation coefficient for triglycerides in the study
group and its ANOVA model was very significant, showing
poor positive correlation with weight for height % while for
total cholesterol it was found to be insignificant. Depending on
results we conclude that it is the most effective food supplement
for the speedy recovery of the impaired lipid metabolism in
SAM children and the use of weight for height % as a
anthropometric marker for the pre-indication of fatty liver in
malnourished children
Effect of time-of-day specific obese training on body composition and physica...IOSR Journals
The best strategy for management of obese, outside pharmacological interventions, is physical exercise associated to diet. Recent research has discovered that the problem of obesity is largely due to a biological clock and that lipid oxidation is higher in the evening compared to the morning and at night compared to day. The purpose of this study is to investigate the effect of time-of-day specific obese training on body composition and physical capacity in obese following a low calorie diet. 20 sedentary pre-obese and obese with a mean BMI of 34.3 kg/m2 aged 20 to 47 years subjects participated in a concurrent strength and specific endurance training for obese. Subjects were divided into two training groups: a Morning training Group (MG: n = 10) and an Evening training Group (EG: n=10). The specific training associated to lower caloric diet has increased physical capacity (17,7% for EG and 15,6% for MG), decreased body weight (7,3% for EG and 6% for MG) fat percentage (19,5% for EG and 11,3% for MG) and waist circumference (10,2% for EG and 8,2% for MG) in both groups. Afternoon training was more effective than morning training on fat loss (24.9% for EG versus 15.9% for MG) and on lean mass variation (+2.9% for EG versus -0.5% for MG).
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Similar to Horbach - 2015 - abiliti closed-loop gastric electrical stimulation system for treatment of obesity - clinical results with a 27 month follow-up (20)
Horbach - 2015 - abiliti closed-loop gastric electrical stimulation system for treatment of obesity - clinical results with a 27 month follow-up
1. ORIGINAL CONTRIBUTIONS
abiliti®
Closed-Loop Gastric Electrical Stimulation System
for Treatment of Obesity: Clinical Results with a 27-Month
Follow-Up
T. Horbach & A. Thalheimer & F. Seyfried &
F. Eschenbacher & P. Schuhmann & G. Meyer
# The Author(s) 2015. This article is published with open access at Springerlink.com
Abstract
Background The aim of the study was to evaluate the safety
and effectiveness of a novel closed-loop gastric electric stim-
ulation device (abiliti®
system) featuring a transgastric sensor
to detect food intake and an accelerometer to record physical
activity to induce and maintain lifestyle changes to treat
obesity.
Methods In a prospective, multi-center study, 34 obese sub-
jects (BMI of 42.1±5.3 kg/m2
) who passed an eligibility eval-
uation were implanted with the abiliti system. Safety evalua-
tion included an endoscopic exam to assess the intragastric
electrode healing. Efficacy evaluation at 1 year of therapy
included weight loss, improvements in eating, and exercise
behavior and quality of life.
Results The transgastric implant controlled by endoscopy was
stable for all participants. At 12 months (12 M) the mean
excess weight loss (EWL) was 28.7 % (95%CI, 34.5 to
22.5 %), and mean reduction in BMI was 4.8±3.2 kg/m2
. At
27 months (27 M), the EWL was 27.5 % (95 % CI, 21.3 % to
33.7 %). Eating behavior, evaluated by the BThree Factor Eat-
ing Questionnaire^, showed a significant increase in the cog-
nition factor and decrease in the disinhibition and hunger fac-
tors at 12 M in comparison to baseline (p<0.001). Participants
significantly increased their weekly physical activity
(p<0.001). Quality of life was improved in 55.2 % of the
patients.
Conclusions Gastric electrical stimulation with abiliti system
in obese participants is well tolerated and leads to significant
12 M weight loss, which was stable to 27 M. We suggest that
weight loss is achieved due to the assessed alteration of eating
behavior in particular the reduction in disinhibition and hun-
ger, and the measured increase in physical activity.
Keywords Gastric electrical stimulation . Weight loss .
Obesity . Implantable stimulation electrodes
Introduction
Morbid obesity is a disease that cannot be successfully treated
with conventional lifestyle interventions such as diet therapy
or increased physical activity in the vast majority of patients
[1–4]. Obesity-related comorbidities necessitate sufficient
therapy, with bariatric surgery being considered the Bgold
standard^, despite the clinically relevant procedure-related
T. Horbach (*) :F. Eschenbacher
Klinik für Allgemein- und Viszeralchirurgie, Schön Klinik Nürnberg
Fürth, Europa-Allee 1, 90763 Fürth, Germany
e-mail: thorbach006@gmail.com
F. Eschenbacher
e-mail: FEschenbacher@schoen-kliniken.de
A. Thalheimer
RoMed Klinik Bad Aibling, Adipositaszentrum, Harthauser Str. 16,
83043 Bad Aibling, Germany
e-mail: Andreas.Thalheimer@ro-med.de
F. Seyfried
Klinik und Poliklinik für Allgemein- und Viszeralchirurgie, Gefäss-
und Kinderchirurgie, Universitätsklinikum Würzburg,
Oberdürrbacher Str. 6, 97080 Würzburg, Germany
e-mail: Seyfried_F@ukw.de
P. Schuhmann :G. Meyer
Zentrum für Adipositas- und Metabolische Chirurgie,
Wolfart-Klinik, Ruffiniallee 17, 82166 Gräfelfing, Germany
P. Schuhmann
e-mail: schuhmann@amc-wolfartklinik.de
G. Meyer
e-mail: gmeyer@hotmail.de
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DOI 10.1007/s11695-015-1620-z
2. morbidity [5, 6]. There is a need for treatment options that
reduce surgery related complications and do not produce a
permanent change in the gastrointestinal track. One of the
options currently under investigation is gastric electrical stim-
ulation (GES). GES has been studied in animal models and
also in clinical trials for more than a decade, with conflicting
results [7–11]. The abiliti system has been designed with
a number of novel features aiming to improve weight
loss results. The stimulation parameters are programma-
ble over a wide range in order to induce symptoms and
early satiety in all patients. A stimulation testing meth-
odology that uses a visual scale was developed,
allowing patients to report their symptom level and ad-
just therapy to the appropriate level at each follow-up as
necessary. In addition, therapy is not delivered continu-
ally throughout the day, but is meal-activated, triggered
by an intragastric sensor. Finally, the abiliti system com-
bines GES with tools to improve participant eating and
exercise behavior, in the form of intake and activity
(3D-accelerometer) sensors which provide objective be-
havior data 24 h a day.
This paper presents the safety and therapeutic efficacy of
the first generation abiliti system over a 12-month period (pro-
tocol based endpoint) with an additional observational follow-
up period offered to all participants and reported here up to the
point of 50 % attrition (27 months).
Research Design and Methods
Study Design
This was a 12-month prospective, multi-center study conduct-
ed in Germany. The protocol was approved by a central ethics
committee (FECI 010/1049) and reviewed by each center’s
ethics committee. The study was conducted in accordance
with Good Clinical Practice and consistent with the Declara-
tion of Helsinki, Informed consent was obtained from all en-
rolled participants.
Study Population
The main participant inclusion and exclusion criteria are listed
in Table 1. Prior to enrollment, the participants were
prescreened using the Three-Factor Eating Questionnaire
(TFEQ), which explores the three dimensions of eating behav-
ior: cognitive restraint of eating, disinhibition, and hunger
[12]. The test was scored using a proprietary algorithm that
characterizes the profile of the highest responders to GES
therapy. The participant’s ability to respond to the gastric elec-
trical therapy was assessed with an endoscopic electrical
stimulation-based sensitivity screening. The participant was
asked to describe their symptoms and to score them on a
visual analogue scale (VAS).
Therapy System
abiliti® is an implantable system that delivers stimulation ther-
apy triggered by a transgastric intake sensor. The stimulation
targets the area of the anterior vagal branches at the lesser
curve of the stomach (Bcrow’s foot^).
Using a programmer and a wand which provides telemetry-
based communication with the device, the physician is trained
to titrate the stimulation parameters based on the participant’s
response and design a participant’s personalized therapy. The
parameters of the pulse-train stimulation (4–30 mA, 100–
2000 μs pulse duration, 40–120 Hz) are adjusted to obtain
the desired symptoms of fullness and satiety, by asking the
participant to report their symptom level using a visual scale.
The daily therapy is individualized by creating Ballowed^ pe-
riods, where therapy is designed to produce satiety, and
Bdisallowed^ periods, where therapy is designed to cause dis-
comfort and stop consumption. The allowed periods are tai-
lored to the participant’s life schedule, to encourage a consis-
tent meal schedule that is preferable for weight loss. Stimula-
tion adjustment is done at initial programming when the stim-
ulation is turned on, and at each subsequent follow-up visit as
necessary.
Table 1 Main inclusion and exclusion criteria
Inclusion criteria Exclusion criteria
• Age 18 to 60 years
• BMI 35 to 55 kg/m2
• HbA1c ≤7 %
• History of obesity ≥5 years
• Women with child-bearing poten-
tial (i.e., not post-menopausal or
surgically sterilized) must agree
to use adequate birth control
methods
• No significant weight loss (<5 %)
within 4 months prior to
enrollment
• Successful psychological
evaluation following the
institution psychological
evaluation protocol for bariatric
surgery
• If taking anti-depressant medica-
tions, they must be stable for at
least 6 months prior to enroll-
ment
• Willingness to refrain from using
prescription, over the counter or
herbal weight loss products for
the duration of the trial
• Any prior bariatric surgery
• Insulin dependent diabetes
• Diagnosed with an eating disorder
such as bulimia or binge eating
• GI disease such as hiatal hernia
(>5 cm), gastroparesis,
esophageal motility disorders
• Any history of peptic ulcer disease
within 5 years prior to
enrollment
• Arthritis or other pathologies
limiting physical activities that
physician feels should exclude
the participant from the study
• Other implanted electrical
stimulation devices (e.g.
pacemaker, defibrillator,
neurostimulator)
• Obesity of known endocrine
origin
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3. The stimulator stores the meal and activity data derived
from the intake sensor and three-axis accelerometer as a daily
log, which is uploaded to the programmer and viewed at each
follow-up visit. A custom model translates the output of the
accelerometer to a daily exercise level and duration.
Device Implantation
The implantation of the device is performed under general
anesthesia similar to other laparoscopic gastric interventions.
Three trocars are used for the standardized procedure. The
transgastric food sensor is implanted in the anterior wall,
body-fundus region, about 3 cm from the greater curvature.
The stimulation electrode is implanted in the anterior wall,
approximately 4 cm from the gastroesophageal junction and
1.5 cm from the lesser curvature of the stomach, at the point
where the Laterjet nerve is divided into three branches
(Bcrow’s foot^). The distance between electrodes should be
3 to 4 cm. Upon inflation of the stomach, a dilating needle is
inserted through the trocar which is nearest and perpendicular
to the implantation site, to pierce the gastric wall and then
place the food sensor electrode with a silicon wafer which is
fixed by a seromuscular suture. An upper endoscopy is per-
formed to confirm the intragastric probe extension. A subcu-
taneous pocket is created in the left upper abdominal quadrant,
the lead is exteriorized and connected to the stimulator, which
is placed in the pocket. Figure 1 illustrates the placement of
the transgastric food sensor, stimulation electrode, and stimu-
lator. The mean duration of the implant surgery was 52.3 min
(range 35–110).
Follow-Up Visits
Two weeks following the implant, the therapy was started, and the
meal schedule and therapy parameters were consequently adjust-
ed for each patient. Monthly follow-up was conducted that in-
cluded weight measurement, dietary counseling and review of
food sensor and activity data provided by the device, and if nec-
essary therapy adjustment based on a stimulation sensitivity test.
Outcome Measures
The primary endpoint was safety of the transgastric implant eval-
uated by endoscopy examination 3 months after implant. The
secondary outcomes were: the frequency and seriousness of all
adverse events; the percentage excess weight loss (%EWL)
measured at each follow-up visit up to 27 month, as-
sessment of eating behavior with the TFEQ and quality
of life with the Moorehead-Ardelt II at baseline and
12 months, and measurement of trends in exercise with
the implanted 3D accelerometer during the first
12 months.
Fig. 1 The transgastric sensor
detects food entry into the
stomach and then triggers the
gastric stimulator to deliver
therapy at the lesser curvature in
the location of the Bcrow’s foot^
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4. Statistical Analysis
Data were pooled across the study sites and are presented as
mean±SD unless otherwise indicated, comparisons were eval-
uated using a paired student’s t test, and physical activity
trends with linear regression. Means, total counts, standard
deviations, medians, ranges, and 95 % confidence intervals
for the means were calculated for continuous measures. Anal-
yses were performed using Excel version 12 (Microsoft Corp.,
Mountain View, California, USA) and SAS Version 9.2 soft-
ware (SAS, Cary, NC, USA).
Results
Study Population
One hundred thirty participants were prescreened, 48 %
passed the TFEQ criteria and 42 participants consented and
were enrolled (Table 2). The disposition of the 42 participants
is detailed in Table 3. Table 4 summarizes the population
characteristics of the 34 implanted patients.
Safety Outcomes
A total of 33 gastro-endoscopic examinations of the
intragastric probe were performed 3 months after device
implant (one participant was explanted for recurrent
subcutaneous pocket seroma 1 month after implant).
All examinations showed the stability of the probe with
a visual estimated measurement of the intragastric ex-
tension >10 mm. Good sealing with normal gastric mu-
cosa around the probe was observed and neither over-
growth nor any signs of local infection or erosion were
seen. All adverse events (AE) were gathered during the
study period. Two AEs were related to the device: ab-
dominal pain due to device position (resolved with re-
positioning of the stimulator under local anesthesia), and
a broken stimulation lead which prevented therapy de-
livery, and resulted in removal from the study. Two AEs
were related to the procedure: one participant presented
a severe recurrent subcutaneous pocket seroma without
infection, the participant requested the device explant
due to discomfort; the second participant developed a
post-surgical superficial wound infection which was re-
solved with antibiotic therapy. There were no intraoper-
ative or serious postoperative complications.
Weight Loss
The participants’ body weight decreased during the en-
tire study period as shown on Fig. 2. The mean %EWL
at 12 months was 28.7 % (95%CI, 34.5 to 22.5 %). The
average WL was 13.1 kg (95%CI, 16.1 to 9.9 kg) and
in BMI was 4.8±3.2 kg/m2
. No significant correlation
was found between baseline BMI and 12 months %
EWL (r=0.37). Sixteen participants of the 31 who com-
pleted the study remained in follow-up at 27 months.
Their weight loss was stable as shown in Fig. 3. The
Table 4 Demographics and baseline characteristics of study population
N=34 Mean (SD) Median Range
(min, max)
Age (years) 43.8 (13.3) 44.0 20, 60
Weight (kg) 117.8 (15.6) 118.0 89.8, 153.7
Excess body
weight (kg)
47.4 (14.2) 43.7 25.8,80.6
BMI (kg/m2
) 41.9 (5.3) 40.6 34.8, 54.3
N Percentage
Gender Male 6 17.6
Female 28 82.4
Table 3 Disposition of participants—all enrolled participants
All enrolled
abiliti participants
(N=42)
n (%)
Withdrew before surgery 8 (19.0)
Reasons for withdrawal
Negative eFITT 6 (14.3)
Voluntary withdrawal 1 (2.4)
Investigator withdrawal 1 (2.4)
Subjects implanted 34
Lost to follow-up <5 months 1 (2.9)
Adverse event (<5 months) 2 (5.9)
Outcome population 31
Subjects completed the study
(12 Months)
31 (100 %)
Italic emphasis signifies that out of the total Subjects Implanted (34), two
subgroups, patients who were lostto followup and patients with adverse
events were subtracted to obtain the final Outcome population (31)
Table 2 Summary of enrollment process at three centers
Site Investigator Prescreened
N
Failed
TFEQ
N (%)
Opted Out
N (%)
Enrolled
N (%)
Schwabach Horbach 28 14 (50) 3 (11) 11 (39)
Wűrzburg Thalheimer,
Seyfried
33 18 (55) 5 (15) 10 (30)
Gräfefing Meyer 70 36 (51) 13 (19) 21 (30)
Totals 131 68 (52) 21 (16) 42 (32)
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5. status of the study population is described in Table 5.
Due to the early generation technology, premature bat-
tery depletion occurred, accounting for some of the at-
trition seen prior to 27 months.
Changes in Eating and Exercise Behavior
At 3 months, the TFEQ individual factors analysis
showed a significant increase in the cognition factor
and decrease in the disinhibition and hunger factors in
comparison to baseline measurements (paired t test
p<0.001). These improvements persisted at 6 and
12 months (p<0.001).
Compared to baseline, the weekly physical activity dura-
tion at 3, 6, and 12 months for all participants was significant-
ly increased (p<0.001), as shown in Fig. 4a, b. However, the
patients who lost less weight (%EWL<25) showed a linear
decrease in weekly exercise after M3 (R2
=0.97), with an av-
erage decrease of 132 min/week between M3 and M12
(p<0.05).
0
5
10
15
20
25
30
35
40
Baseline 3 6 9 12
%EWL±95%CI
MonthFig. 2 Weight loss outcomes:
%EWL at 3, 6, 9, and 12 months
(mean±95 % CI, n=31), and
Individual BMI change at
12 months (n=31) each line
segment represents the change in
BMI for each subject from
baseline to 12 months, showing
no correlation between baseline
BMI and reduction achieved
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6. Quality of Life
The quantitative analysis showed a mean increase of 1.0 point
for all participants at 12 months compared with their baseline
values. This increase represented a qualitative change in cate-
gory from BFair^ to BGood^. The individual key area scores
were also analyzed, and four areas significantly improved at
12 months (Fig. 5).
Discussion
This prospective study confirms the safety and efficacy of the
abiliti system in the treatment of obesity over a period of
27 months, but a longer-term study is needed. The use of a
transgastric probe was shown to be safe as confirmed by en-
doscopic examination. The mean duration of surgery and
invasiveness was comparable to the placement of a gastric
band [13]. Compared to other bariatric surgeries reporting
gastric symptoms including reflux and vomiting [14], GES
treatment was well tolerated by the participants with no ad-
verse reactions noted due to the programmed stimulation ther-
apy. The WL results published by the nonrandomized GES
studies previously performed in Europe and USA ranged from
21 to 23 % EWL [9, 15]. This study shows an improvement in
outcome (28.7 % (95%CI, 22.5 to 34.5 % EWL)).
The overall quality of life for all participants significantly
improved when comparing baseline to 12 months, these re-
sults are consistent with other successful surgical WL thera-
pies [16, 17]. The Moorehead-Ardelt QOL II questionnaire
has been shown to be well correlated with widely used health
and well-being indicators [18], the score has a positive corre-
lation with WL, but is not a good indicator of digestive side
effects [19].
The changes in the participants’ eating behavior as assessed
by the TFEQ show that abiliti therapy improves self-
awareness and confidence in their ability to control their eat-
ing and decreases hunger for all participants. These findings
are consistent with the results from weight loss studies using
surgical and behavioral therapy [20–23]. The significant re-
duction in hunger supports the enhancement of satiety as a
WL mechanism with GES therapy.
The effect of the system’s ability to modify eating behavior
is seen in the stable WL of participants that remained in long-
term follow-up. The relatively large percentage of patients
remaining in follow-up for more than 2 years, compared to a
30 % attrition rate at 1 year for pharmacotherapy [24] is
Table 5 Status of study population (N=31) at 27 months
Status Subjects
N (%)
Total remaining in follow-up 16 (52)
Still implanted, no longer in follow-up (battery depletion oc-
curred and explants were being scheduled (N=5), and par-
ticipants could not be contacted (N=2))
7 (23)
Explanted (reasons: not satisfied with weight loss (5),
interfered with sports (1), battery depletion (1))
7 (23)
Deceased (not procedure- or therapy related) 1 (3)
34343333323131313131313131
28
252422222222
1919191919191716
16.1
23.4
26.3 28.5 29.3 28.2
23.6
25.8 27.5
0
10
20
30
40
50
60
70
80
90
1000
5
10
15
20
25
30
35
40
45
50
0 3 6 9 12 15 18 21 24 27
PatientsinFollowup(N)
%EWL±95%CI
MonthFig. 3 %EWL±95%CI
throughout the 27 months, with
the number of patients remaining
in the study at each follow-up in-
dicated with the corresponding
bar
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7. 0
100
200
300
400
500
A
B
M0 M3 M6 M12
Exercise(min/week)±SEM
Moderate/Vigorous
Light/Moderate
No linear trend
* **
0
100
200
300
400
500
M0 M3 M6 M12
Exercise(min/week)±SEM
Linear decrease
R2 = 0.97
*
*
ǂ decreased from
M3 (p<0.05)
* * increased from
baseline (p <0.05)
ǂ
Fig. 4 The weekly exercise (min/
week) is shown for high
performers (a EWL≥25, N=18)
and lower performers (b EWL<
25, N=13) groups at baseline, 3,
6, and 12 months. The higher
performing group exercised
consistently between months 3
and 12, at a higher level than
baseline, while the low
performing group also maintained
a higher exercise level compared
to baseline, but between M3 and
M12 showed a linear decrease
(R2
=0.97) in exercise
-0.2
0
0.2
0.4
0.6
0.8
1
1.2
Score
M0
M12
p = 0.001 p < 0.001p = 0.06 p = 0.44
p < 0.001
p < 0.001
p < 0.001Fig. 5 Change in overall QOL
score and key area scores from
baseline to 12 months. From
baseline to 12 months, the overall
quality of life improved for 16
subjects (55.17 %), remained the
same for 10 (34.48 %) and
declined for 3 (10.34 %).
Analyzing individual key area
scores, four areas were
significantly improved at
12 months, self esteem, physical,
sexual, and focus on eating
(p<0.001)
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8. evidence of patient satisfaction with the combination of stable
weight loss and high quality of life achieved with the positive
behavioral changes promoted by the system This is in contrast
to the drastic lifestyle modifications required with other bar-
iatric procedures [25]. Variability in weight loss results can be
observed in clinical studies regardless of the treatment ap-
plied, behavioral, or surgical [6, 26], suggesting many factors
affect weight loss outcomes; including psychological, behav-
ioral, and environmental factors. To minimize these factors, an
arduous screening process was applied in the control random-
ized SHAPE trial [10] (4802 candidates screened, 190 partic-
ipants enrolled). This process did not improve the study out-
come possibly because it identified a control group highly
selected to succeed with a low-calorie diet and a monthly
support group. In the abiliti study, the TFEQ was chosen as
a prescreening process to limit the population to participants
with a high Bcognitive restraint^ factor—which has been
shown to be particularly important in the successful treatment
of obesity—and a high hunger factor—because they may ben-
efit from a treatment which enhances satiety [12]. In addition,
a participant’s response to GES therapy will differ based on
their specific neural anatomy and stimulation response thresh-
old. Yao [27] showed that the inhibitory effects of gastric
stimulation were correlated with the visceral sensitivity of
the participant to gastric stimulation. The endoscopic stimula-
tion test was designed to test patient sensitivity to electrical
neural stimulation of the gastric wall before performing sur-
gery, and 14 % of the participants were screened out because
they lacked the required response. The type of symptoms ob-
served were a feeling of satiety or fullness for 42 % of the
participants, gastric pressure for 58 %, and nausea for 16 %.
The mode of stimulation may partially explain the im-
provement in WL compared to other GES systems, since the
other stimulators provided continuous stimulation below the
participant’s symptomatic threshold. Continuous stimulation
may engender a neuromuscular adaptation phenomenon [28]
that could be responsible for loss of efficacy. Furthermore,
asymptomatic stimulation may not be enough; the early sen-
sation of satiety and fullness may be ignored by some partic-
ipants. GES that is adapted to the individual and programmed
to be above sensation threshold has been shown to be effective
in a recent animal study [29]. Gastric banding and other obe-
sity surgical procedures penalize the participants when they
are overeating (e.g., pain, nausea, vomiting), and these dis-
agreeable symptoms force the participant to maintain appro-
priate eating behavior. But these penalties can also lead to the
creation of aberrant eating habits.
The abiliti system has both an activity and a food intake
sensor which can provide objective sensor-based feedback
which has been shown to promote behavioral modification
[30–32]. Using the activity data provided by the device, the
clinician was able to advise and encourage the patient to-
wards reaching their exercise goals, resulting in the
observed increase in total weekly exercise duration. The
study results show a progressive increase in exercise dura-
tion and intensity throughout the follow-up period for the
participants with higher WL, confirming the importance of
exercise in long-term weight loss [33]. In addition to trig-
gering the therapy, the food intake sensor also provides
important behavioral feedback regarding eating time and
frequency, which helps the clinician identify patterns [34]
and focus on solving issues with regards to an individual
patient’s eating habits.
This study is limited due to the lack of a control group. A
blinded control group is challenging because the abiliti thera-
py combines both GES and sensor-based behavior feedback.
We expect that improvement in patient behavior with sensor-
based feedback is due to a combination of increased self-
awareness, and awareness that their behavior is being
monitored.
Conclusion
In this prospective study, GES proved to be safe with prom-
ising treatment results. The abiliti®
system offers a weight loss
therapy option that has the advantage of no permanent ana-
tomic changes. The study has shown that the abiliti system
creates change in both eating and exercise behavior which
leads to sustained weight loss. Guided by behavior change
theories such as presented by Prochaska et al. [35], clinicians
of different obesity treatment disciplines could use the sensor
data provided by the abiliti system to effectively promote
long-term adherence to exercise and diet guidelines. These
results warrant additional controlled clinical studies to confirm
long-term safety and efficacy of the therapy system.
Acknowledgments The study was financially supported by IntraPace
Inc, San Jose, CA, USA. We acknowledge investigator site personnel for
support in data collection.
Disclosure ClinicalTrials.gov Identifier: NCT01539850
Informed consent was obtained from all individual participants in-
cluded in the study.
The study was conducted in accordance with Good Clinical Practice
and consistent with the Declaration of Helsinki.
Dr. Horbach reports personal fees from IntraPace, Inc, during the
conduct of the study.
Open Access This article is distributed under the terms of the Creative
Commons Attribution License which permits any use, distribution, and
reproduction in any medium, provided the original author(s) and the
source are credited.
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