Incorporating an Exercise Rehabilitation Programme for People with Intermittent Claudication into an Established Cardiac Rehabilitation Service: A Protocol for a Pilot Study

Overview

Journal Contemp Clin Trials Commun

Date 2019 Aug 8

PMID 31388598

Citations 3

Authors

Edward Caldow

Andrew Findlow

Malcolm Granat

Mariyana Schoultz

Affiliations

Soon will be listed here.

Abstract

Introduction: Current UK guidance for the treatment of intermittent claudication (IC) states that supervised exercise programmes (SEPs) should be offered as first-line treatment [1], prior to surgical interventions. However, there is currently a national shortage of dedicated SEPs. It has been suggested that the established network of UK Cardiac Rehabilitation (CR) programmes could cater for IC patients. This study will investigate the feasibility of combining IC and CR patients into one SEP, and explore the patient perception's regarding the treatment programme, to establish whether CR could potentially fill the gap in service provision.

Methods And Analysis: Patients diagnosed with IC will be incorporated into a CR programme where they will exercise alongside patients with coronary artery disease (CAD). Participants will attend a 2-h class, once a week for a total of 12 weeks. Another group of IC patients will attend an SEP consisting solely of other IC patients (control group).

Outcome Measures: The study will evaluate the feasibility of recruitment, retention, and participant experience of the intervention as well as physiological outcomes (primary outcome: pain-free walking, and maximal walking distance; secondary outcomes: physical activity levels, perceived walking ability, and disease-specific quality of life). Outcomes will be assessed at baseline and on completion of the SEP.

Ethics And Dissemination: Ethical approval for this study was obtained from North West- Greater Manchester West Research Ethics Committee on 13th June 2018 (IRAS ID: 230391). This study is registered with clinicaltrials. gov (NCT03564080) and conforms to the Declaration of Helsinki. Results will be disseminated via national conferences and published in peer-reviewed journals.

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References

Morgan M, Crayford T, Murrin B, Fraser S . Developing the Vascular Quality of Life Questionnaire: a new disease-specific quality of life measure for use in lower limb ischemia. J Vasc Surg. 2001; 33(4):679-87. DOI: 10.1067/mva.2001.112326. View

Stewart K, Hiatt W, Regensteiner J, Hirsch A . Exercise training for claudication. N Engl J Med. 2002; 347(24):1941-51. DOI: 10.1056/NEJMra021135. View

Cheetham D, Burgess L, Ellis M, Williams A, Greenhalgh R, Davies A . Does supervised exercise offer adjuvant benefit over exercise advice alone for the treatment of intermittent claudication? A randomised trial. Eur J Vasc Endovasc Surg. 2003; 27(1):17-23. DOI: 10.1016/j.ejvs.2003.09.012. View

de Vries M, Ouwendijk R, Kessels A, de Haan M, Flobbe K, Hunink M . Comparison of generic and disease-specific questionnaires for the assessment of quality of life in patients with peripheral arterial disease. J Vasc Surg. 2005; 41(2):261-8. DOI: 10.1016/j.jvs.2004.11.022. View

Hankey G, Norman P, Eikelboom J . Medical treatment of peripheral arterial disease. JAMA. 2006; 295(5):547-53. DOI: 10.1001/jama.295.5.547. View

Bendermacher B, Willigendael E, Teijink J, Prins M . Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication. Cochrane Database Syst Rev. 2006; (2):CD005263. DOI: 10.1002/14651858.CD005263.pub2. View

Norgren L, Hiatt W, Dormandy J, Nehler M, Harris K, Fowkes F . Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007; 45 Suppl S:S5-67. DOI: 10.1016/j.jvs.2006.12.037. View

Wind J, Koelemay M . Exercise therapy and the additional effect of supervision on exercise therapy in patients with intermittent claudication. Systematic review of randomised controlled trials. Eur J Vasc Endovasc Surg. 2007; 34(1):1-9. DOI: 10.1016/j.ejvs.2006.12.030. View

Watson L, Ellis B, Leng G . Exercise for intermittent claudication. Cochrane Database Syst Rev. 2008; (4):CD000990. DOI: 10.1002/14651858.CD000990.pub2. View

10.

Shalhoub J, Hamish M, Davies A . Supervised exercise for intermittent claudication - an under-utilised tool. Ann R Coll Surg Engl. 2009; 91(6):473-6. PMC: 2966198. DOI: 10.1308/003588409X432149. View

11.

Gardner A, Skinner J, Cantwell B, Smith L . Progressive vs single-stage treadmill tests for evaluation of claudication. Med Sci Sports Exerc. 1991; 23(4):402-8. View

12.

Evans R, Singh S, Collier R, Loke I, Steiner M, Morgan M . Generic, symptom based, exercise rehabilitation; integrating patients with COPD and heart failure. Respir Med. 2010; 104(10):1473-81. DOI: 10.1016/j.rmed.2010.04.024. View

13.

Gardner A, Montgomery P, Parker D . Optimal exercise program length for patients with claudication. J Vasc Surg. 2012; 55(5):1346-54. PMC: 3340530. DOI: 10.1016/j.jvs.2011.11.123. View

14.

Bassett D . Device-based monitoring in physical activity and public health research. Physiol Meas. 2012; 33(11):1769-83. DOI: 10.1088/0967-3334/33/11/1769. View

15.

Clarke C, Holdsworth R, Ryan C, Granat M . Free-living physical activity as a novel outcome measure in patients with intermittent claudication. Eur J Vasc Endovasc Surg. 2012; 45(2):162-7. DOI: 10.1016/j.ejvs.2012.11.027. View

16.

Risom S, Zwisler A, Rasmussen T, Sibilitz K, Svendsen J, Gluud C . The effect of integrated cardiac rehabilitation versus treatment as usual for atrial fibrillation patients treated with ablation: the randomised CopenHeartRFA trial protocol. BMJ Open. 2013; 3(2). PMC: 3586151. DOI: 10.1136/bmjopen-2012-002377. View

17.

Hiatt W, Regensteiner J, Hargarten M, Wolfel E, Brass E . Benefit of exercise conditioning for patients with peripheral arterial disease. Circulation. 1990; 81(2):602-9. DOI: 10.1161/01.cir.81.2.602. View

18.

Stansfield B, Clarke C, Dall P, Godwin J, Holdsworth R, Granat M . True cadence and step accumulation are not equivalent: the effect of intermittent claudication on free-living cadence. Gait Posture. 2014; 41(2):414-9. DOI: 10.1016/j.gaitpost.2014.11.002. View

19.

Granat M, Clarke C, Holdsworth R, Stansfield B, Dall P . Quantifying the cadence of free-living walking using event-based analysis. Gait Posture. 2015; 42(1):85-90. DOI: 10.1016/j.gaitpost.2015.04.012. View

20.

Tam M, Longenecker C, Chow C, Vest M, Sukeena R, Mohan S . Occult peripheral artery disease is common and limits the benefit achieved in cardiac rehabilitation. Vasc Med. 2016; 21(2):130-6. DOI: 10.1177/1358863X15625370. View