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NIHR Signal Exercise improves intermittent claudication leg pain on walking

Published on 10 April 2018

doi: 10.3310/signal-00582

People with intermittent claudication who participate in structured exercise programmes can walk about 80 metres further without experiencing leg pain than those who do not do the programme. They can also walk about 120 metres further overall.

Intermittent claudication is a cramp-like pain in the legs caused by narrowing of the arteries, which restricts blood flow to the muscles. There’s increasing evidence that maintaining physical activity can help. This updated systematic review combined data from 32 trials involving 1,835 adults with stable leg pain.

The quality of evidence was high for the main outcomes of how far people could walk in total and without pain. Exercises varied (for example, cycling, pole-striding) though most programmes were delivered at least twice weekly over three to 12 months.

The findings support NICE recommendations to offer supervised exercise programmes as the first-line approach for people with intermittent claudication.

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Why was this study needed?

Many people over the age of 60 experience some degree of peripheral arterial disease, where there is narrowing or blockage of blood vessels supplying the legs and feet and about 4% can get claudication. This leg pain comes on with exercise and improves with rest (hence intermittent claudication). In most cases, it will not worsen, but blood supply to the limb becomes severely compromised for about one in five which can lead to amputation.  

Intermittent claudication can cause people to reduce the amount they exercise which can further harm health and wellbeing. Many studies show that physical activity improves symptoms. Exercise programmes have been recommended by NICE for many years, but despite this uptake in the UK remains low.

This is the fourth Cochrane update on this topic, which adds two further trials to the existing evidence in support of these interventions.

What did this study do?

The updated systematic review included 32 randomised controlled trials assessing the effect of exercise programmes in 1,835 people with stable leg pain.

Most trials compared with usual care (excluding advice on exercise/walking) though a few compared with anti-clotting drugs or placebo tablets or interventions. Studies comparing different types of exercise, unsupervised exercise or vascular interventions were excluded. Exercises varied, including cycling, pole-striding, strength training, upper or lower limb exercises. Programme duration was mostly three to 12 months. All studies included at least two exercise sessions per week. The best-assessed walking distance or time by a treadmill test.

The most likely source of potential bias was research staff being aware of group assignment, either at time of allocation or assessment. Six studies came from the UK.

What did it find?

  • People who participated in exercise were able to walk on average 82 metres further without pain than those receiving usual care (95% confidence interval [CI] 72 to 92 metres). This was based on high-quality evidence from nine trials involving 391 participants with a follow-up time of six weeks to 24 months.
  • They were also able to walk further in total than those in no-exercise groups (mean difference 120 metres, 95% CI 51 to 190). This was high-quality evidence from 10 trials in 500 participants.
  • The trials were too small to measure any effect on deaths or amputations.
  • There was a modest effect on quality of life (about two points on a 100 point scale).

What does current guidance say on this issue?

NICE guidelines on peripheral arterial disease diagnosis and management were updated in 2018. NICE recommend that all people with intermittent claudication are offered a supervised exercise programme. This is suggested to involve two hours of supervised exercise a week for a three month period, with people encouraged to exercise to the point of maximal pain. 

Vascular intervention to open the obstructed arteries (angioplasty) is only recommended if a supervised exercise programme has not lead to a satisfactory improvement in symptoms, and other advice on controlling risk factors (e.g. smoking, diabetes) has been followed.

What are the implications?

This review adds support to the current NICE guidelines that people with intermittent claudication should be offered supervised exercise programmes before any consideration of invasive intervention. Another Cochrane review has also shown that supervised exercise improves walking distance compared to unsupervised exercise, such as simple advice from GPs.

It seems that not all eligible patients may be benefitting from this guidance, so this review should add weight to decision-making around providing these interventions.

Citation and Funding

Lane R, Harwood A, Watson L, et al. Exercise for intermittent claudication. Cochrane Database Syst Rev. 2017;(12):CD000990.

The Cochrane Vascular editorial base is supported by a National Institute for Health Research programme grant, and the Chief Scientific Office UK.

Bibliography

NICE. Peripheral arterial disease: diagnosis and management. CG147. London: National Institute for Health and Care Excellence; 2000.

Fokkenrood HJP, Bendermacher BLW, Lauret GJ, et al. Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication. Cochrane Database Syst Rev. 2013;(8):CD005263.

Why was this study needed?

Many people over the age of 60 experience some degree of peripheral arterial disease, where there is narrowing or blockage of blood vessels supplying the legs and feet and about 4% can get claudication. This leg pain comes on with exercise and improves with rest (hence intermittent claudication). In most cases, it will not worsen, but blood supply to the limb becomes severely compromised for about one in five which can lead to amputation.  

Intermittent claudication can cause people to reduce the amount they exercise which can further harm health and wellbeing. Many studies show that physical activity improves symptoms. Exercise programmes have been recommended by NICE for many years, but despite this uptake in the UK remains low.

This is the fourth Cochrane update on this topic, which adds two further trials to the existing evidence in support of these interventions.

What did this study do?

The updated systematic review included 32 randomised controlled trials assessing the effect of exercise programmes in 1,835 people with stable leg pain.

Most trials compared with usual care (excluding advice on exercise/walking) though a few compared with anti-clotting drugs or placebo tablets or interventions. Studies comparing different types of exercise, unsupervised exercise or vascular interventions were excluded. Exercises varied, including cycling, pole-striding, strength training, upper or lower limb exercises. Programme duration was mostly three to 12 months. All studies included at least two exercise sessions per week. The best-assessed walking distance or time by a treadmill test.

The most likely source of potential bias was research staff being aware of group assignment, either at time of allocation or assessment. Six studies came from the UK.

What did it find?

  • People who participated in exercise were able to walk on average 82 metres further without pain than those receiving usual care (95% confidence interval [CI] 72 to 92 metres). This was based on high-quality evidence from nine trials involving 391 participants with a follow-up time of six weeks to 24 months.
  • They were also able to walk further in total than those in no-exercise groups (mean difference 120 metres, 95% CI 51 to 190). This was high-quality evidence from 10 trials in 500 participants.
  • The trials were too small to measure any effect on deaths or amputations.
  • There was a modest effect on quality of life (about two points on a 100 point scale).

What does current guidance say on this issue?

NICE guidelines on peripheral arterial disease diagnosis and management were updated in 2018. NICE recommend that all people with intermittent claudication are offered a supervised exercise programme. This is suggested to involve two hours of supervised exercise a week for a three month period, with people encouraged to exercise to the point of maximal pain. 

Vascular intervention to open the obstructed arteries (angioplasty) is only recommended if a supervised exercise programme has not lead to a satisfactory improvement in symptoms, and other advice on controlling risk factors (e.g. smoking, diabetes) has been followed.

What are the implications?

This review adds support to the current NICE guidelines that people with intermittent claudication should be offered supervised exercise programmes before any consideration of invasive intervention. Another Cochrane review has also shown that supervised exercise improves walking distance compared to unsupervised exercise, such as simple advice from GPs.

It seems that not all eligible patients may be benefitting from this guidance, so this review should add weight to decision-making around providing these interventions.

Citation and Funding

Lane R, Harwood A, Watson L, et al. Exercise for intermittent claudication. Cochrane Database Syst Rev. 2017;(12):CD000990.

The Cochrane Vascular editorial base is supported by a National Institute for Health Research programme grant, and the Chief Scientific Office UK.

Bibliography

NICE. Peripheral arterial disease: diagnosis and management. CG147. London: National Institute for Health and Care Excellence; 2000.

Fokkenrood HJP, Bendermacher BLW, Lauret GJ, et al. Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication. Cochrane Database Syst Rev. 2013;(8):CD005263.

Exercise for intermittent claudication

Published on 27 December 2017

Lane, R.,Harwood, A.,Watson, L.,Leng, G. C.

Cochrane Database Syst Rev Volume 12 , 2017

BACKGROUND: Exercise programmes are a relatively inexpensive, low-risk option compared with other, more invasive therapies for treatment of leg pain on walking (intermittent claudication (IC)). This is the fourth update of a review first published in 1998. OBJECTIVES: Our goal was to determine whether an exercise programme was effective in alleviating symptoms and increasing walking treadmill distances and walking times in people with intermittent claudication. Secondary objectives were to determine whether exercise was effective in preventing deterioration of underlying disease, reducing cardiovascular events, and improving quality of life. SEARCH METHODS: For this update, the Cochrane Vascular Information Specialist searched the Specialised Register (last searched 15 November 2016) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 10) via the Cochrane Register of Studies Online, along with trials registries. SELECTION CRITERIA: Randomised controlled trials of an exercise regimen versus control or versus medical therapy for people with IC due to peripheral arterial disease (PAD). We included any exercise programme or regimen used for treatment of IC, such as walking, skipping, and running. Inclusion of trials was not affected by duration, frequency, or intensity of the exercise programme. Outcome measures collected included treadmill walking distance (time to onset of pain or pain-free walking distance and maximum walking time or maximum walking distance), ankle brachial index (ABI), quality of life, morbidity, or amputation; if none of these was reported, we did not include the trial in this review. DATA COLLECTION AND ANALYSIS: For this update (2017), RAL and AH selected trials and extracted data independently. We assessed study quality by using the Cochrane 'Risk of bias' tool. We analysed continuous data by determining mean differences (MDs) and 95% confidence intervals (CIs), and dichotomous data by determining risk ratios (RRs) and 95% CIs. We pooled data using a fixed-effect model unless we identified significant heterogeneity, in which case we used a random-effects model. We used the GRADE approach to assess the overall quality of evidence supporting the outcomes assessed in this review. MAIN RESULTS: We included two new studies in this update and identified additional publications for previously included studies, bringing the total number of studies meeting the inclusion criteria to 32, and involving a total of 1835 participants with stable leg pain. The follow-up period ranged from two weeks to two years. Types of exercise varied from strength training to polestriding and upper or lower limb exercises; supervised sessions were generally held at least twice a week. Most trials used a treadmill walking test for one of the primary outcome measures. The methodological quality of included trials was moderate, mainly owing to absence of relevant information. Most trials were small and included 20 to 49 participants. Twenty-seven trials compared exercise versus usual care or placebo, and the five remaining trials compared exercise versus medication (pentoxifylline, iloprost, antiplatelet agents, and vitamin E) or pneumatic calf compression; we generally excluded people with various medical conditions or other pre-existing limitations to their exercise capacity.Meta-analysis from nine studies with 391 participants showed overall improvement in pain-free walking distance in the exercise group compared with the no exercise group (MD 82.11 m, 95% CI 71.73 to 92.48, P < 0.00001, high-quality evidence). Data also showed benefit from exercise in improved maximum walking distance (MD 120.36 m, 95% CI 50.79 to 189.92, P < 0.0007, high-quality evidence), as revealed by pooling data from 10 studies with 500 participants. Improvements were seen for up to two years.Exercise did not improve the ABI (MD 0.04, 95% CI 0.00 to 0.08, 13 trials, 570 participants, moderate-quality evidence). Limited data were available for the outcomes of mortality and amputation; trials provided no evidence of an effect of exercise, when compared with placebo or usual care, on mortality (RR 0.92, 95% CI 0.39 to 2.17, 5 trials, 540 participants, moderate-quality evidence) or amputation (RR 0.20, 95% CI 0.01 to 4.15, 1 trial, 177 participants, low-quality evidence).Researchers measured quality of life using Short Form (SF)-36 at three and six months. At three months, the domains 'physical function', 'vitality', and 'role physical' improved with exercise; however this was a limited finding, as it was reported by only two trials. At six months, meta-analysis showed improvement in 'physical summary score' (MD 2.15, 95% CI 1.26 to 3.04, P = 0.02, 5 trials, 429 participants, moderate-quality evidence) and in 'mental summary score' (MD 3.76, 95% CI 2.70 to 4.82, P < 0.01, 4 trials, 343 participants, moderate-quality evidence) secondary to exercise. Two trials reported the remaining domains of the SF-36. Data showed improvements secondary to exercise in 'physical function' and 'general health'. The other domains - 'role physical', 'bodily pain', 'vitality', 'social', 'role emotional', and 'mental health' - did not show improvement at six months.Evidence was generally limited in trials comparing exercise versus antiplatelet therapy, pentoxifylline, iloprost, vitamin E, and pneumatic foot and calf compression owing to small numbers of trials and participants.Review authors used GRADE to assess the evidence presented in this review and determined that quality was moderate to high. Although results showed significant heterogeneity between trials, populations and outcomes were comparable overall, with findings relevant to the claudicant population. Results were pooled for large sample sizes - over 300 participants for most outcomes - using reproducible methods. AUTHORS' CONCLUSIONS: High-quality evidence shows that exercise programmes provided important benefit compared with placebo or usual care in improving both pain-free and maximum walking distance in people with leg pain from IC who were considered to be fit for exercise intervention. Exercise did not improve ABI, and we found no evidence of an effect of exercise on amputation or mortality. Exercise may improve quality of life when compared with placebo or usual care. As time has progressed, the trials undertaken have begun to include exercise versus exercise or other modalities; therefore we can include fewer of the new trials in this update.

Expert commentary

It is recognised that patients with intermittent claudication benefit from regular periods of supervised exercise, increasing the maximum distance they can walk, and distance walked before the onset of pain.

However, availability of supervised exercise programmes is variable, and not all patients can adhere to a strict regimen of walking. This study tends to suggest that other forms of regular exercise also have symptomatic benefit.

Firm recommendations for patients to undertake some form of regular exercise may not only improve walking, but also mental and physical aspects of quality of life, underlining the premise that exercise is good for you!

Frank CT Smith, Professor of Vascular Surgery & Surgical Education, University of Bristol & North Bristol NHS Healthcare Trust, Southmead Hospital