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Exercise and intermittent claudication
- 1. D2.S3.2(5) The BASES expert statement on exercise training for people with intermittent claudication due to peripheral arterial disease Garry Tew1*, Amy Harwood2, Lee Ingle2, Ian Chetter2 & Patrick Doherty3 1Northumbria University, 2University of Hull, 3University of York *Email: garry.tew@northumbria.ac.uk Twitter: @garry_tew Attendance at this conference was supported by a BASES Expert Statement Grant
- 2. What is peripheral arterial disease (PAD) and intermittent claudication? What is PAD? • Narrowing of blood vessels supplying the legs Prevalence? • 13% of Western population aged 50+ Major risk factors? • Smoking, diabetes, dyslipidaemia Underlying disease process? • Atherosclerosis
- 3. Management of intermittent claudication Purpose? • Relieve symptoms • Secondary prevention of CVD Clinical guideline • NICE CG147 (2012) NICE Pathway: Purpose of our BASES expert statement? To provide an overview of the evidence on exercise training and recommendations for people delivering exercise programmes to this population
- 4. Evidence on exercise training - What are the core outcome measures? Walking ability • Treadmill testing (e.g. ‘Gardner’ protocol) • Maximum walking distance (primary) • Pain-free walking distance (secondary) • 6-minute walk test Quality of life • Generic questionnaires • SF-36 v2 • EQ-5D • Disease-specific questionnaires • VascuQoL • ICQ
- 5. Effects of exercise training on walking ability and quality of life Latest Cochrane Review: Lane et al. (2017) Outcome measure Mean diff (95% CI) Exercise vs control No. of participants (studies) Quality of evidence (GRADE) Pain-free walking distance (6wk-24m) 82 m (72 to 92 m) N = 391 (9 RCTs) High Maximum walking distance (6wk-24m) 120 m (51 to 190 m) N = 500 (10 RCTs) High Quality of life: SF-36 Physical (6m) 2.15 (1.26 to 3.04) N = 429 (5 RCTs) Moderate Quality of life: SF-36 Mental (6m) 3.76 (2.7 to 4.82) N = 343 (4 RCTs) Moderate
- 6. What is the optimal mode of exercise? Latest Cochrane Review: Lauret et al. (2014) N = 153 (5 RCTs) “no clear evidence of differences between supervised walking exercise and alternative exercise modes” Mode Effect on walking ability Comment Walking – strong pain +++ Patients may be unwilling to exercise with pain Walking – minimal pain ++ Not extensively studied Arm/leg ergometry ++ May generate greater CV stimulus than walking Resistance training + Has a complementary role (e.g. strengthening)
- 7. How much does supervision matter? Latest Cochrane Review: Hageman et al. (2018) Outcome measure Mean diff (95% CI) SET vs home-based No. of participants (studies) Quality of evidence (GRADE) Pain-free walking distance (3m) SMD 0.51 (0.21 to 0.81) N = 322 (7 RCTs) Moderate Maximum walking distance (3m) SMD 0.37 (0.12 to 0.62) N = 351 (8 RCTs) Moderate Quality of life: SF-36 Physical (6m) 0.00 (‐4.79 to 4.79) N = 68 (2 RCTs) Low Quality of life: SF-36 Mental (6m) 1.19 (‐4.47 to 6.86) N = 68 (2 RCTs) Low
- 8. How safe is supervised exercise training? Latest systematic review: Gommans et al. (2015) • 74 RCTs representing 82,725 hours of training in 2,876 IC patients • 8 events, 1 fatal Event Number Fatal myocardial infarction 1 Non-fatal cardiac arrest 2 Angina pectoris 1 Heart arrhythmias 1 Increased HR and dyspnoea 1 Worsening of osteoarthritis 1 Sciatica 1 Conclusion: “SET can safely be prescribed in IC patients because cardiovascular complication rates associated with this type of therapy are extremely low” Limitations: • Description of adverse events sometimes lacking (35/74 studies make explicit reference) • Stringent eligibility criteria of RCTs limits generalisability to routine practice
- 9. Recommendations 1. Clinically assess and risk stratify patients at entry 2. Supervise sessions and have clinical oversight 3. Use walking as the main mode of exercise 4. Use the following programme characteristics: • Programme duration: At least 3 months • Frequency: At least 3 sessions per week • Session duration: 30-60 minutes • Pattern: Intermittent exercise to near-maximum leg pain 5. Monitor acute responses to exercise 6. Measure core outcomes at entry and exit
- 10. Thank you for listening garry.tew@northumbria.ac.uk The full statement is available from the BASES website: https://www.bases.org.uk/spage- resources- bases_expert_statements.html
Editor's Notes
- Good afternoon everyone. Thank you for the introduction. I would like to start by acknowledging BASES for supporting my attendance at this conference, and my co-authors for their hard work in helping prepare this expert statement.
- So I’m going to start by providing some background information about peripheral arterial disease and intermittent claudication. PAD is a type of CVD where the blood vessels supplying the legs become narrowed due to the build up of fatty plaques. It effects around 13% of the Western population aged over 50 years of age, and major risk factors for its development include smoking, diabetes and dyslipidemia. PAD itself is a risk factor for other CV problems such as heart attack and stroke, because the underlying disease process of atherosclerosis is a systemic process meaning blood vessels elsewhere in the body may be affected. The most common symptom of PAD is intermittent claudication, which is muscle pain in the legs or buttocks brought on by walking and relieved by rest. It occurs due to a mismatch between O2 demand and delivery during exercise. Intermittent claudication can cause marked reductions in people’s functional capacity and quality of life.
- The main goals of treatment in this population include relief of symptoms and secondary prevention of CVD, which can be achieved through some combination of lifestyle changes, drug therapy and invasive revascularisation procedures. In the UK, NICE Clinical Guideline 147 provides recommendations on how best to diagnose and manage IC. The figure shows the preferred management pathway, in which a 3-month programme of supervised exercise training is recommended as a primary therapy. The recommendation about exercise is very basic, and because of this we thought it would be useful to produce a more detailed supporting statement that provides an update of the evidence and expanded recommendations aimed at people who deliver exercise programmes to this population.
- The next 5 slides will focus on the evidence followed by a single slide on recommendations. To narrow the focus of our evidence review, we first sought to identify the main outcome measures that are used in trials of exercise for people with IC. We found that the large majority of trials use some measure of walking ability as the primary outcome measure with quality of life often assessed as a secondary outcome. Treadmill walking protocols are often used to quantify walking ability, and the Gardner protocol has been widely used. Here the participant walking at 3.2 kph with the gradient increasing by 2% every 2 min. They are asked to report when they first experience leg pain, and then to continue walking until they have to stop. The two distances represent the pain-free and maximum walking distances respectively. A few trials have also used the 6-min walk test, which is thought to correlate better with community-based walking ability. Various quality of life questionnaires have been used. Common generic ones include the SF-36 and EQ5D. Common disease-specific ones include the VascuQol and Intermittent Claudication Questionnaire.
- There have been a few Cochrane systematic reviews about exercise for IC. The one I’m going to summarise first, that of Lane and colleagues, sought to include all RCTs of exercise programmes regardless of the mode of exercise or level of supervision. This summary of findings table shows the outcome measure, meta-analysis results for exercise versus no exercise comparisons, the number of contributing participants and studies, and the quality ratings. In short, the review found high quality evidence of a beneficial effect of exercise on walking ability and moderate quality evidence for a beneficial effect on physical and mental aspects of QoL. Improvements of this magnitude have the potential to be clinically significant.
- In most studies, exercise programmes have involved treadmill or track walking at a sufficient intensity to bring on moderate to strong claudication pain. There is a well-developed evidence base supporting this type of training for improving walking ability and clinical guidelines around the world cite it as the preferred modality. Other modes of training have not been extensively studied. For example, the 2014 Cochrane review of Lauret et al. only found 5 smalls trials that had compared the effects of different modes of exercise, with overall inconclusive findings. Nevertheless, work my myself, John Saxton and others has shown that cycling and arm-cranking are viable alternatives to walking for improving walking ability and QoL. Resistance training has been shown to have a limited effect on walking ability, but it should be promoted alongside aerobic training for complimentary reasons like supporting the maintenance of muscle strength.
- The next question we sought to address was does the intensity of supervision matter? Well, according to this recent Cochrane review, it would appear so. Meta-analysis findings indicated that supervised exercise programmes elicited larger improvements in walking ability but not QoL than home-based exercise programmes. An economic evaluation that was done to inform the UK NICE Clinical Guidelines also indicated that supervised exercise was more cost-effective than either unsupervised exercise or angioplasty. Supervised and home-based programmes both appear superior to the provision of basic walking advice, which generally has a minimal effect on people’s exercise behaviour. Despite this, few structured exercise programmes exist for people with IC in the UK, making it difficult for patients to access this effective therapy.
- I’ve already mentioned that PAD is a risk factor for heart attack and stroke, and PAD also tends to present in older people who have multimorbidity. Therefore, it is reasonable to consider PAD as a high risk patient group when it comes to exercise-based therapy. But how safe is exercise in this group? The best evidence for this probably comes from this systematic review of adverse events in RCTs of supervised exercise programmes. 74 RCTs were included, representing over 2800 patients and 82k hours of exercise training. Only 8 AEs were reported, of which one was fatal. This death resulted from a myocardial infarction that occurred in a small German study that was published in the 70s. Overall, the authors concluded that supervised exercise training can be safely prescribed due to the low rate of complications. However, some noteworthy limitations of this review include a possible under-reporting of AEs in primary studies and stringent eligibility criteria limiting generalisability to routine practice.
- So far I’ve told you that PAD with IC is a common form of CVD that can have a marked effect on peoples’ functional capacity and QoL. I’ve also presented evidence that supports the position of supervised exercise training as a primary therapy. I’m going to finish this presentation by offering 6 recommendations for people who may be involved in the delivery of exercise training to this patient group. Firstly, patients should be clinically assessed to ensure they do not have any contraindications to exercise and to document any comorbidities or treatments that may need to be accounted for in the exercise programme. Two, exercise should ideally be delivered through an on-site supervised exercise programme with clinical oversight. However, a facilitated self-managed exercise programme is a reasonable alternative for people who prefer this approach or are unable to access supervised exercise. Next, walking exercise should be considered the primary mode of exercise for improving walking ability and claudication symptoms. A structured programme of intermittent walking exercise at an intensity that elicits moderate to strong claudication pain should be conducted for at least 3 months and involving at least three 30-60 min sessions/week. Five, acute psychophysiological responses to exercise should be monitored for safety and to guide exercise progression, and finally programme entry and exit tests should be done to determine changes in patient-important outcomes.
- Our full statement, which includes expanded recommendations, can be accessed via the BASES website. Thank you everyone for listening, I would be happy to answer any questions.