Integrating patients with intermittent claudication into an established cardiac rehabilitation programme: a feasibility study with embedded pilot

Caldow, EJ

Abstract

Introduction: In the UK, it is recommended that people diagnosed with intermittent claudication (IC) receive exercise therapy as first-line treatment of their condition. The optimal delivery of this treatment is a hospital-based, supervised exercise programme (SEP). Despite this recommendation, there is a national shortage of SEPs in the UK with limited numbers of peripheral artery disease (PAD) patients receiving this preferred treatment option. Financial restrictions and lack of qualified staff available to supervise the programmes are the main limitations to service provision. Integrating patients with IC into an already established network of Cardiac Rehabilitation Programmes (CRPs) has been proposed as a solution to this service problem, however, no study has yet been conducted to investigate the feasibility of this combined rehabilitation.

Aim: The main aim of this study was to assess the feasibility of an integrated CRP for patients with IC. The study also aimed to collect pilot data to guide the methodology for a future randomised control trial (RCT).

Methods: To address the aims of this study, a parallel two-armed feasibility study was conducted across two hospital sites. One site acted as the IC control group (standard care) and the second acted as the treatment group (integrated CRP) recruiting both IC and coronary artery disease (CAD) patients. Feasibility measures included: number of eligible patients, recruitment and retention rates, number of adverse events, and acceptability of trial and treatment procedures. Acceptability of the trial and treatment procedures was investigated through both quantitative data (e.g., return rates on questionnaires and exercise diaries) and qualitatively through semi-structured focus groups and individual interviews with both patients and staff.
Pilot data was collected pre- and post-SEP including exercise capacity, free-living activity, and patient-reported outcome measures (PROMs). Maximal walking distance (MWD), taken from the exercise test of IC participants, was used for an a priori sample size calculation to inform a future RCT study.
Both the quantitative and qualitative data was used to evaluate the study’s methodology to guide a future large-scale RCT.

Results: Eligibility rates were 85% for the IC control group, 92% for the IC treatment group, and 81% for the CAD group. A total of 19 IC patients were recruited to the control group, and 17 IC patients and 21 CAD patients were simultaneously recruited to the intervention giving consent rates of 36%, 24%, and 26%, respectively. Retention rates were 79% IC control group, 65% for the IC intervention group and 72% for the CAD group. No adverse events were reported during the study.
There were high return rates for all questionnaires and participants found the trial measures to be low burden. The qualitative assessment of treatment acceptability recruited 8 patients from the IC control group (54%), 4 patients from the IC intervention group (36%), and 6 patients from the CAD group (40%). Four themes emerged from these interviews: Staff, Shared Experience, Rehabilitation Setting, and Barriers. Ten CRP staff were recruited to assess their acceptability to the treatment. Three themes emerged from these interviews: adaptations to service, differences between patient groups, and making a difference.
The IC control group mean maximal walking distance (MWD) significantly increased by 219 metres post-SEP (p= <0.001), and the IC treatment group’s mean MWD significantly increased by 283.7 metres post-SEP (p= 0.007). The improvements in walking capacity between the two IC groups were not significantly different (p= 0.495). The CAD groups improved their functional capacity similar to national averages for patients attending CR in the UK.
Using the pilot data for mean improvement in PWT in the IC treatment group, for a future trial to see a significant change with an 82% power at the 5% level of significance, 25 participants would be needed for each participant group.

Conclusion: An integrated CRP is feasible for patients with IC. Furthermore, combining IC and CAD patients may have the additional benefits to a single-disease rehabilitation model due to peer support and changed patient illness perception.
Although CRP staff found the implementation of the integrated programme initially difficult, they perceived it as a logical development in service provision. They enjoyed the opportunity for professional development offered by delivering rehabilitation to a different clinical group, and felt they were making a difference to PAD and CAD patients’ treatment.
A fully powered RCT is required to establish the efficacy of integrated CRP for PAD patients in the UK.

Citation

Caldow, E. Integrating patients with intermittent claudication into an established cardiac rehabilitation programme: a feasibility study with embedded pilot. (Thesis). University of Salford

• Thesis Type: Thesis
• Deposit Date: Nov 2, 2022
• Publicly Available Date: Nov 2, 2022
• Award Date: Jun 29, 2022