Telemedicine-based individualised aerobic exercise training in Chinese adults with inactive or mildly active inflammatory bowel disease: study protocol for a single-centre, semi-crossover randomised controlled trial

基于远程医疗的个体化有氧运动训练对中国患有非活动性或轻度活动性炎症性肠病的成年人的影响:一项单中心、半交叉随机对照试验的研究方案

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Abstract

BACKGROUND: Inflammatory bowel disease (IBD) patients in China exhibit critically low levels of physical activity, yet evidence for telemedicine-based aerobic exercise interventions remains scarce, particularly with objective physiological validation. METHODS AND ANALYSIS: In this single-centre, open-labelled, semi-crossover randomised controlled trial, 28 inactive/mildly active adult IBD patients with low level of baseline physical activity will be randomly assigned to immediate or delayed 12-week telemedicine-based aerobic exercise training. The exercise prescription, stratified by baseline activity level, is designed to progressively elevate physical activity levels to moderate intensity. The telemedicine-based programme used fitness bands synchronised to a mobile app, WeChat-based real-time feedback and online group support and communication. The primary outcome is change in peak oxygen uptake measured by cardiopulmonary exercise testing (CPET). Secondary outcomes include other cardiorespiratory fitness parameters measured by CPET, physical activity level measured by International Physical Activity Questionnaire Short Form, Exercise Benefits/Barriers Scale, clinical disease activity, inflammatory markers, Inflammatory Bowel Disease Questionnaire, nutritional indices, Fatigue Severity Scale and Hospital Anxiety and Depression Score. ETHICS AND DISSEMINATION: The trial has been approved by the Ethics Committee of the Affiliated Lihuili Hospital of Ningbo University (KY2024SL379-01). Results will be published in peer-reviewed journals and presented at scientific conferences. TRIAL REGISTRATION NUMBER: NCT06804733.

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