Feasibility of high-intensity interval training and moderate-intensity continuous training in adults with inactive or mildly active Crohn’s disease: study protocol for a randomised controlled trial

Abstract

BackgroundStructured exercise training has been proposed as a useful adjunctive therapy for Crohn’s disease by improving immune function and psychological health, reducing fatigue and promoting gains in muscle and bone strength. However, the evidence for exercise in Crohn’s disease is sparse, with only a handful of small prospective trials [1, 2], with methodological limitations, including the use of non-randomised and non-controlled study designs and small sample sizes. Here, we describe the protocol for a study that aims to assess the feasibility and acceptability of two common types of exercise training—high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT)—in adults with inactive or mildly active Crohn’s disease (CD).MethodsThis is a randomised, controlled, assessor-blinded, feasibility trial with three parallel groups. Forty-five adults with inactive or mildly active Crohn’s disease will be randomly assigned 1:1:1 to HIIT, MICT or usual care control. Participants in the HIIT and MICT groups will be invited to undertake three sessions of supervised exercise each week for 12 consecutive weeks. HIIT sessions will consist of ten 1-min intervals of cycling exercise at 90% of peak power output separated by 1 min of active recovery. MICT sessions will involve 30 min of continuous cycling at 35% of peak power output. Participants will be assessed before randomisation and 13 and 26 weeks after randomisation. Feasibility outcomes include rates of recruitment, retention and adherence. Interviews with participants will explore the acceptability of the exercise programmes and study procedures. Clinical/health outcomes include cardiorespiratory fitness, body mass index, resting blood pressure, markers of disease activity (faecal calprotectin and Crohn’s Disease Activity Index) and activated T cell cytokine profiles. Study questionnaires include the Inflammatory Bowel Disease Quality of Life Questionnaire, EQ-5D-5L, IBD Fatigue Scale, Hospital and Anxiety Depression Scale, and International Physical Activity Questionnaire.DiscussionThis study will provide useful information on the feasibility and acceptability of supervised exercise training in adults with inactive and mildly active Crohn’s disease and will inform the design of a subsequent, adequately powered, multi-centre trial.Trial RegistrationThe trial is registered with the International Standard Randomised Controlled Trial Register (ISRCTN13021107). Date registration assigned was 02/12/2015.

High-intensity interval training and moderate-intensity continuous training in adults with Crohn’s disease: a pilot randomised controlled trial

“…A full description of the methods has been published [19]. The study was a multi-centre, three-arm, parallel-group, pilot randomised controlled trial.…”

European Crohn’s and Colitis Organisation Topical Review on Complementary Medicine and Psychotherapy in Inflammatory Bowel Disease

“…217 A trial assessing two exercise regimens in adults with inactive or mildly active CD is currently underway. 218 New technology, including nextgeneration wearable physical activity trackers, could potentially improve exercise studies and might be used to promote physical activity 219 in IBD patients.…”

Validity of the EQ-5D-5L and EQ-5D-3L in patients with Crohn’s disease

“…A number of studies have confirmed the improved psychometric properties of the 5L in both general population and patient samples, including cancer, chronic hepatic diseases, diabetes, osteoarthritis, psoriasis and stroke [29]. No studies have reported on HRQoL in patients with CD as assessed by the 5L, and only two published clinical trial protocols, planning to use the 5L questionnaire in CD patients, are present [30,31]. Nevertheless, as of the time this manuscript was written, results…”