Incorporating an exercise rehabilitation programme for people with intermittent claudication into an established cardiac rehabilitation service: A protocol for a pilot study

Caldow, Edward, Findlow, Andrew, Granat, Malcolm and Schoultz, Mariyana (2019) Incorporating an exercise rehabilitation programme for people with intermittent claudication into an established cardiac rehabilitation service: A protocol for a pilot study. Contemporary Clinical Trials Communications, 15. p. 100389. ISSN 2451-8654

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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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