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Meta-Analysis
. 2017 Dec 26;12(12):CD000990.
doi: 10.1002/14651858.CD000990.pub4.

Exercise for intermittent claudication

Risha Lane  1 , Amy Harwood, Lorna Watson, Gillian C Leng
Affiliations
Meta-Analysis

Exercise for intermittent claudication

Risha Lane et al. Cochrane Database Syst Rev. .

Abstract

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.

PubMed Disclaimer

Conflict of interest statement

RL: none known. AH: none known. LW: none known. GCL: I am responsible for the National Institute for Health and Care Excellence (NICE) Implementation programme and I am the Executive Director of NICE. I am a trustee of the Royal Society of Medicine and the Guidelines International Network.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Funnel plot of comparison: 1 Overall outcomes: exercise regimen compared with placebo or usual care, outcome: 1.1 Maximum walking time (min).
5
5
Funnel plot of comparison: 1 Overall outcomes: exercise regimen compared with placebo or usual care, outcome: 1.4 Pain‐free walking time (min).
6
6
Funnel plot of comparison: 1 Overall outcomes: Exercise regimen compared with placebo or usual care, outcome: 1.5 Ankle brachial index.
1.1
1.1. Analysis
Comparison 1 Overall outcomes: exercise regimen compared with placebo or usual care, Outcome 1 Maximum walking distance (m).
1.2
1.2. Analysis
Comparison 1 Overall outcomes: exercise regimen compared with placebo or usual care, Outcome 2 Pain‐free walking distance (m).
1.3
1.3. Analysis
Comparison 1 Overall outcomes: exercise regimen compared with placebo or usual care, Outcome 3 Maximum walking time (min).
1.4
1.4. Analysis
Comparison 1 Overall outcomes: exercise regimen compared with placebo or usual care, Outcome 4 Pain‐free walking time (min).
1.5
1.5. Analysis
Comparison 1 Overall outcomes: exercise regimen compared with placebo or usual care, Outcome 5 Change in MWD/T.
1.6
1.6. Analysis
Comparison 1 Overall outcomes: exercise regimen compared with placebo or usual care, Outcome 6 Change in ICD/T.
1.7
1.7. Analysis
Comparison 1 Overall outcomes: exercise regimen compared with placebo or usual care, Outcome 7 Ankle brachial index.
1.8
1.8. Analysis
Comparison 1 Overall outcomes: exercise regimen compared with placebo or usual care, Outcome 8 Mortality.
1.9
1.9. Analysis
Comparison 1 Overall outcomes: exercise regimen compared with placebo or usual care, Outcome 9 Amputation.
1.10
1.10. Analysis
Comparison 1 Overall outcomes: exercise regimen compared with placebo or usual care, Outcome 10 Peak exercise calf blood flow (mL/100 mL/min).
2.1
2.1. Analysis
Comparison 2 Three‐monthly outcomes: exercise regimen compared with placebo or usual care, Outcome 1 Maximum walking distance (m).
2.2
2.2. Analysis
Comparison 2 Three‐monthly outcomes: exercise regimen compared with placebo or usual care, Outcome 2 Pain‐free walking distance (m).
2.3
2.3. Analysis
Comparison 2 Three‐monthly outcomes: exercise regimen compared with placebo or usual care, Outcome 3 Maximum walking time (min).
2.4
2.4. Analysis
Comparison 2 Three‐monthly outcomes: exercise regimen compared with placebo or usual care, Outcome 4 Pain‐free walking time (min).
2.5
2.5. Analysis
Comparison 2 Three‐monthly outcomes: exercise regimen compared with placebo or usual care, Outcome 5 Ankle brachial index.
2.6
2.6. Analysis
Comparison 2 Three‐monthly outcomes: exercise regimen compared with placebo or usual care, Outcome 6 Mortality.
2.7
2.7. Analysis
Comparison 2 Three‐monthly outcomes: exercise regimen compared with placebo or usual care, Outcome 7 Quality of Life SF‐36.
2.8
2.8. Analysis
Comparison 2 Three‐monthly outcomes: exercise regimen compared with placebo or usual care, Outcome 8 Peak exercise calf blood flow (mL/100 mL/min).
3.1
3.1. Analysis
Comparison 3 Six‐monthly outcomes: exercise regimen compared with placebo or usual care, Outcome 1 Maximum walking distance (m).
3.2
3.2. Analysis
Comparison 3 Six‐monthly outcomes: exercise regimen compared with placebo or usual care, Outcome 2 Pain‐free walking distance (m).
3.3
3.3. Analysis
Comparison 3 Six‐monthly outcomes: exercise regimen compared with placebo or usual care, Outcome 3 Maximum walking time (min).
3.4
3.4. Analysis
Comparison 3 Six‐monthly outcomes: exercise regimen compared with placebo or usual care, Outcome 4 Pain‐free walking time (min).
3.5
3.5. Analysis
Comparison 3 Six‐monthly outcomes: exercise regimen compared with placebo or usual care, Outcome 5 Ankle brachial index.
3.6
3.6. Analysis
Comparison 3 Six‐monthly outcomes: exercise regimen compared with placebo or usual care, Outcome 6 Mortality.
3.7
3.7. Analysis
Comparison 3 Six‐monthly outcomes: exercise regimen compared with placebo or usual care, Outcome 7 Quality of Life SF‐36.
3.8
3.8. Analysis
Comparison 3 Six‐monthly outcomes: exercise regimen compared with placebo or usual care, Outcome 8 Peak exercise calf blood flow (mL/100 mL/min).
4.1
4.1. Analysis
Comparison 4 Exercise regimen compared with antiplatelet therapy, Outcome 1 Maximum walking time (min).
4.2
4.2. Analysis
Comparison 4 Exercise regimen compared with antiplatelet therapy, Outcome 2 Ankle brachial index.
4.3
4.3. Analysis
Comparison 4 Exercise regimen compared with antiplatelet therapy, Outcome 3 Peak exercise calf blood flow (mL/100 mL/min).
5.1
5.1. Analysis
Comparison 5 Exercise regimen compared with pentoxifylline therapy, Outcome 1 Maximum walking time (min).
6.1
6.1. Analysis
Comparison 6 Exercise regimen compared with iloprost therapy, Outcome 1 Maximum walking distance (m).
6.2
6.2. Analysis
Comparison 6 Exercise regimen compared with iloprost therapy, Outcome 2 Pain‐free walking distance (m).
7.1
7.1. Analysis
Comparison 7 Exercise regimen compared with pneumatic foot and calf compression, Outcome 1 Maximum walking distance (m).
7.2
7.2. Analysis
Comparison 7 Exercise regimen compared with pneumatic foot and calf compression, Outcome 2 Pain‐free walking distance (m).
7.3
7.3. Analysis
Comparison 7 Exercise regimen compared with pneumatic foot and calf compression, Outcome 3 Mortality.
8.1
8.1. Analysis
Comparison 8 Exercise regimen compared with vitamin E, Outcome 1 3‐monthly maximum walking time (min).
8.2
8.2. Analysis
Comparison 8 Exercise regimen compared with vitamin E, Outcome 2 6‐monthly maximum walking time (min).
8.3
8.3. Analysis
Comparison 8 Exercise regimen compared with vitamin E, Outcome 3 3‐monthly ABI.
8.4
8.4. Analysis
Comparison 8 Exercise regimen compared with vitamin E, Outcome 4 6‐monthly ABI.
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References

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References to studies excluded from this review

Allen 2010 {published data only}
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Bulling 1991 {published data only}
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Cachovan 1999 {published data only}
    1. Cachovan M, Rogatti W, Creutzig A, Diehm C, Heidrich H, Scheffler P, et al. Treadmill testing for evaluation of claudication: comparison of constant‐load and graded‐exercise tests. European Journal of Vascular and Endovascular Surgery 1997;14(4):238‐43. - PubMed
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Carmeli 2004 {published data only}
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Cheetham 2004 {published data only}
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Choi 2012 {published data only}
    1. Choi KKS, Etnyre G, Figoni SF, Kunkel CF, Ornelas CC, Scremin E. Comparison of calf exercise and treadmill training in peripheral arterial disease. American Academy of Physical Medicine and Rehabilitation Conference 2012; Vol. 4, issue 10 Suppl:S346 (Poster 457).
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    1. Cina G, Vernich M, Campisi C, Cascone C, Ofria F, Leopardi N, et al. Physical training and low‐dose heparin‐calcium in patients suffering from chronic obliterating arteriopathy of the lower limbs with intermittent claudication [Training fisico ed eparina calcica a basse dosi in pazienti affetti da arteriopatia obliterante cronica degli arti inferiori con claudicatio intermittens]. Minerva Cardioangiologica 1996;44(4):179‐85. - PubMed
CLEVER 2009 {published data only}
    1. Bronas UG, Hirsch AT, Murphy T, Badenhop D, Collins TC, Ehrman JK, et al. CLEVER Research Group. Design of the multicenter standardized supervised exercise training intervention for the claudication: exercise vs endoluminal revascularization (CLEVER) study. Vascular Medicine 2009;14(4):313‐21. - PubMed
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    1. Murphy TP. Supervised exercise vs. primary stenting for claudication due to aorto‐iliac peripheral artery disease: 6‐month outcomes from the CLEVER Study. European Heart Journal 2012;33(1):144‐5.
    1. Murphy TP, Cutlip DE, Regensteiner JG, Mohler ER, Cohen DJ, Reynolds MR, et al. CLEVER Study Investigators. Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six‐month outcomes from the claudication: exercise versus endoluminal revascularization (CLEVER) study. Circulation 2012;125(1):130‐9. - PMC - PubMed
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    1. Collins T. Walking therapy for patients with diabetes mellitus and peripheral arterial disease who are limited by leg pain and/or fatigue. Atherosclerosis Supplements 2011;12(1):118‐9.
    1. Collins T, Ghidei W, Ahluwalia J. Benefits of walking therapy in patients with diabetes mellitus and peripheral arterial disease who are limited by leg pain or fatigue. Journal of General Internal Medicine 2011;26:S176‐7.
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Collins 2012 {published data only}
    1. Collins EG, McBurney C, Butler J, Jelinek C, O'Connell S, Fritschi C, et al. The effects of walking or walking‐with‐poles training on tissue oxygenation in patients with peripheral arterial disease. International Journal of Vascular Medicine 2012;2012:Article 985025. - PMC - PubMed
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Crowther 2008 {published data only}
    1. Crowther RG, Spinks WL, Leicht AS, Sangla K, Quigley F, Golledge J. Effects of a long‐term exercise program on lower limb mobility, physiological responses, walking performance, and physical activity levels in patients with peripheral arterial disease. Journal of Vascular Surgery 2008;47(2):303‐9. - PubMed
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Cucato 2011 {published data only}
    1. Cucato GG, Ritti‐Dias RM, Wolosker N, Santarem JM, Jacob Filho W, Forjaz CL, et al. Post‐resistance exercise hypotension in patients with intermittent claudication. Clinics (Sao Paulo, Brazil) 2011;66(2):221‐6. - PMC - PubMed
Cucato 2011a {published data only}
    1. Cucato GG, Forjaz CL, Kanegusuku H, Rocha Chehuen M, Riani Costa LA, Wolosker N, et al. Effects of walking and strength training on resting and exercise cardiovascular responses in patients with intermittent claudication. Vasa 2011;40(5):390‐7. - PubMed
Cucato 2015 {published data only}
    1. Cucato GG, Saxton JM. Post‐walking exercise hypotension in patients with intermittent claudication. Medicine and Science in Sports and Exercise 2015;47(3):460‐7. - PubMed
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Dantas 2016 {published data only}
    1. Dantas FF, Silva Santana F, Silva TS, Cucato GG, Farah BQ, Ritti‐Dias RM. Acute effects of T'ai Chi Chuan exercise on blood pressure and heart rate in peripheral artery disease patients. Journal of Alternative and Complementary Medicine (New York, N.Y.) 2016;22:375‐9. - PubMed
Dedes 2010 {published data only}
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Degischer 2002 {published data only}
    1. Degischer S, Labs KH, Hochstrasser J, Aschwanden M, Tschoepl M, Jaeger KA. Physical training for intermittent claudication: a comparison of structured rehabilitation versus home‐based training. Vascular Medicine 2002;7(2):109‐15. - PubMed
Dittmar 1977 {published data only}
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    1. Ernst E, Kollar L, Resch KL, Bergmann H. Arterial occlusive disease. Comparison between pentoxifylline and exercise vs. exercise alone in patients with stage II of disease. Munchener Medizinische Wochenschrift 1990;132(28‐29):456‐8.
EXERT 2009 {published data only}
    1. NCT00895635. Evaluating two exercise training programs to reduce leg pain in people with peripheral arterial disease (The EXERT study). clinicaltrials.gov/ct2/show/NCT00895635 Date first received: 6 May 2009.
EXITPAD 2010 {published data only}
    1. Gommans LNM, Scheltinga MRM, Sambeek MRHM, Maas AHEM, Bendermacher BLW, Teijink JAW. Gender differences following supervised exercise therapy in patients with intermittent claudication. Journal of Vascular Surgery 2015;62:681‐8. - PubMed
    1. Nicolai SP, Hendriks EJ, Prins MH, Teijink JA, EXITPAD Study Group. Optimizing supervised exercise therapy for patients with intermittent claudication. Journal of Vascular Surgery 2010;52(5):1226‐33. - PubMed
    1. Nicolai SP, Teijink JA, Prins MH, Exercise Therapy in Peripheral Arterial Disease Study Group. Multicenter randomized clinical trial of supervised exercise therapy with or without feedback versus walking advice for intermittent claudication. Journal of Vascular Surgery 2010;52(2):348‐55. - PubMed
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    1. Asselt AD, Nicolai SP, Joore MA, Prins MH, Teijink JA, Exercise Therapy in Peripheral Arterial Disease Study Group. Cost‐effectiveness of exercise therapy in patients with intermittent claudication: supervised exercise therapy versus a 'go home and walk' advice. European Journal of Vascular and Endovascular Surgery 2011;41(1):97‐103. - PubMed
Fakhry 2011 {published data only}
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Fitzgerald 1971 {published data only}
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Gardner 2005 {published data only}
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Gardner 2011 {published data only}
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    1. Gardner AW, Montgomery PS, Parker DE. Optimal exercise program length for patients with claudication: a randomized controlled trial. Journal of Cardiopulmonary Rehabilitation and Prevention 2011; Vol. 31:E4‐5.
Gardner 2014 {published data only}
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Gardner 2014a {published data only}
    1. Gardner AW, Parker DE, Montgomery PS, Blevins SM. Step‐monitored home exercise improves ambulation, vascular function, and inflammation in symptomatic patients with peripheral artery disease: a randomized controlled trial. Journal of the American Heart Association 2014;3(5):e001107. - PMC - PubMed
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Gibbs 2013 {published data only}
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Gottstein 1987 {published data only}
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Greenhalgh 2008 {published data only}
    1. Greenhalgh RM. MIMIC Trials: Angioplasty effective in randomised controlled trials for peripheral arterial disease. http://www.cxvascular.com/interventionalnews/latestnews.cfm?ccs=485&.... accessed 2 February 2009.
    1. Greenhalgh RM, Belch JJ, Brown LC, Gaines PA, Gao L, Reise JA, et al. The adjuvant benefit of angioplasty in patients with mild to moderate intermittent claudication (MIMIC) managed by supervised exercise, smoking cessation advice and best medical therapy: results from two randomised trials for stenotic femoropopliteal and aortoiliac arterial disease. European Journal of Vascular and Endovascular Surgery 2008;36(6):680‐8. - PubMed
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    1. Guirro EC, Guirro RR, Dibai‐Filho AV, Pascote SCS, Rodrigues‐Bigaton D. Immediate effects of electrical stimulation, diathermy, and physical exercise on lower limb arterial blood flow in diabetic women with peripheral arterial disease: a randomized crossover trial. Journal of Manipulative and Physiological Therapeutics 2015;38(3):195‐202. - PubMed
Hobbs 2006 {published data only}
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    1. Hobbs SD, Marshall T, Fegan C, Adam DJ, Bradbury AW. The constitutive procoagulant and hypofibrinolytic state in patients with intermittent claudication due to infrainguinal disease significantly improves with percutaneous transluminal balloon angioplasty. Journal of Vascular Surgery 2006;43(1):40‐6. - PubMed
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LIFE Study {published data only}
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Mannarino 1989 {published data only}
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    1. Mazari F, Khan J, Abdul Rahman MNA, Mehta T, Gulati S, McCollum P, et al. Cost utility analysis of a randomised control trial of percutaneous transluminal angioplasty (PTA), supervised exercise programme (SEP) and combined treatment (PTA+SEP) for patients with intermittent claudication (IC) due to femoropopliteal disease. The Vascular Society of Great Britain and Ireland Yearbook. 2009:44.
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NCT01241747 {published data only}
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NCT02075502 {published data only}
    1. NCT02075502. Community walking exercise for patients with peripheral artery disease (GAIT). clinicaltrials.gov/ct2/show/NCT02075502. Date first received: 13 February 2014.
NCT02879019 {published data only}
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Nicolai 2010 {published data only}
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Nordanstig 2011 {published data only}
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References to other published versions of this review

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Publication types