Cross-sectoral rehabilitation intervention for patients with intermittent claudication versus usual care for patients in non-operative management - the CIPIC Rehab Study: study protocol for a randomised controlled trial

Abstract

Introduction: Intermittent claudication (IC) caused by peripheral artery disease (PAD) is a common cardiovascular disease. Patients with IC have reduced walking capacity, restricted activity levels and mobility, and reduced healthrelated quality of life. The disease leads to social isolation, the risk of cardiovascular morbidity, and mortality. Nonoperative management of IC requires exercise therapy and studies show that supervised exercise training is more effective than unsupervised training, yet many patients with IC lack motivation for changes in health behaviour. No studies investigating the effects of existing cardiac rehabilitation targeted patients with IC have been published. The aim of this article is to present the rationale and design of the CIPIC Rehab Study, which examines the effect of a cross-sectoral rehabilitation programme versus usual care for patients in non-operative management for IC. Methods and analysis: A randomised clinical trial aims to investigate whether cardiac rehabilitation for patients with IC in non-operative management versus usual care is superior to treatment as usual. The trial will allocate 118 patients, with a 1:1 individual randomisation to either the intervention or control group. The primary outcome is maximal walking distance measured by the standardised treadmill walking test. The secondary outcome is pain-free walking distance measured by the standardised treadmill walking test, healthy diet measured by a fat-fish-fruit-green score, and level of physical activity measured by an activity score within official recommendations. Statistical analyses will be blinded. Several exploratory analyses will be performed. A mixed-method design is used to evaluate qualitative and quantitative findings. A qualitative and a survey-based complementary study will be undertaken to investigate patients' post-discharge experiences. A qualitative post-intervention study will explore experiences of participation in rehabilitation.

Cardiovascular Rehabilitation Increases Walking Distance in Patients With Intermittent Claudication. Results of the CIPIC Rehab Study: A Randomised Controlled Trial

“…Exploratory outcomes were assessed as multiple testing with significant effects interpreted in the context of increased risk of type I error. Clinical effect size reported by Cohen's d. 12 Analyses were performed using SAS 9.4.…”

“…The design and methods of the CIPIC Rehab Study have been described in a previous design paper 12 and are summarised here. The trial also incorporates a qualitative component, details of which will be published elsewhere.…”

Improving Rehabilitation for Patients with Intermittent Claudication: A Randomized Controlled Trial with a Mixed-Methods Evaluation (The CIPIC Rehab Study)

“…Therefore, there is a need to add qualitative data into a quantitative experimental trial to enrich data about how to set up a rehabilitation programme that fits patients with intermittent claudication. As preplanned findings from the quantitative and qualitative analyses must be integrated to address whether the qualitative results could help explain the quantitative results and bring forward additional information [11,12].…”