Dataset Information

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 health-related quality of life. The disease leads to social isolation, the risk of cardiovascular morbidity, and mortality. Non-operative 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. DISCUSSION:The study is the first to assess the effect of a cardiac rehabilitation programme designed for patients with IC. The study will describe how to monitor and improve rehabilitation programmes for patients with IC in a real-world setting. Mixed-method strategies can allow for both exploration and generalisation in the same study, but the research design is a complex intervention and any effects found cannot be awarded a specific component. TRIAL REGISTRATION:Retrospectively registered in Clinicaltrials.gov identifier: NCT03730623.

SUBMITTER: Siercke M

PROVIDER: S-EPMC6975054 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Siercke Maj M Jørgensen Lise Pyndt LP Missel Malene M Thygesen Lau Caspar LC Blach Pernille Peppercorn PP Sillesen Henrik H Berg Selina Kikkenborg SK

Trials 20200121 1

<h4>Introduction</h4>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 health-related quality of life. The disease leads to social isolation, the risk of cardiovascular morbidity, and mortality. Non-operative management of IC requires exercise therapy and studies show that supervised exercise training is more effective than unsupervised t ...[more]

PMID: 31964402

Similar Datasets

Project description:The purpose of this study was to assess the functional effects and acceptability of rocker-soled shoes that were designed to relatively "unload" the calf muscles during walking in people with calf claudication due to peripheral arterial disease.In this randomised AB/BA crossover trial, participants completed two assessment visits up to two weeks apart. At each visit, participants completed walking tests whilst wearing the unloading shoes or visually-similar control shoes. At the end of the second visit, participants were given either the unloading or control shoes to use in their home environment for 2 weeks, with the instruction to wear them for at least 4 h every day. The primary outcome was 6-min walk distance. We also assessed pain-free walking distance and gait biomechanical variables during usual-pace walking, adverse events, and participants' opinions about the shoes. Data for continuous outcomes are presented as mean difference between conditions with corresponding 95% confidence interval.Thirty-four participants (27 males, mean age 68 years, mean ankle-brachial index 0.54) completed both assessment visits. On average, the 6-min walk distance was 11 m greater when participants wore the control shoes (95% CI -5 to 26), whereas mean pain-free walking distance was 7 m greater in the unloading shoes (95% CI -17 to 32). Neither of these differences were statistically significant (p?=?0.18 and p?=?0.55, respectively). This was despite the unloading shoes reducing peak ankle plantarflexion moment (mean difference 0.2 Nm/kg, 95% CI 0.0 to 0.3) and peak ankle power generation (mean difference 0.6 W/kg, 95% CI 0.2 to 1.0) during pain-free walking. The survey and interview data was mixed, with no clear differences between the unloading and control shoes.Shoes with modified soles to relatively unload the calf muscles during walking conferred no substantial acute functional benefit over control shoes.Clinicaltrials.gov, Trial Registration Number: NCT02505503 , First registered 22 July 2015.

Dataset Information

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.

Publications

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.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets