Home-Based, Telematic Gradual Exercise for Permanent Colostomy Patients: Protocol for a Randomized Controlled Trial

Abstract

Background/Objectives: Permanent colostomy requires significant physical and psychological adaptation. Patients often experience reduced physical activity, impaired quality of life, and fear of movement. Current exercise recommendations are inconsistent, and no consensus exists on safe return to activity. This study aims to evaluate the effect of a 12-week home-based graded exercise programme on physical activity, quality of life, kinesiophobia, exercise capacity, and self-efficacy in patients with permanent colostomies. Methods: This randomized controlled trial will recruit 51 adults with permanent colostomies, beginning six weeks post-surgery. Participants will be randomized (1:1) to an intervention or control group. The intervention group will receive a 12-week home-based exercise programme including patient education, resistance and core training, and progressive aerobic walking. The control group will receive standard medical care and an informational leaflet. Primary outcomes include physical activity (steps/day), quality of life (Stoma-QoL), kinesiophobia (Tampa Scale), exercise capacity (6-Minute Walk Test), and self-efficacy (General Self-Efficacy Questionnaire). Follow-up will be conducted at baseline, post-intervention, and six months. Data will be analyzed using intention-to-treat principles with a significance threshold of p < 0.05. Conclusions: This trial will be the first to assess the effects of a structured, home-based graded exercise programme in individuals with permanent colostomies. The findings are expected to provide evidence on the efficacy of exercise for improving physical and psychological outcomes in this population and to inform clinical guidelines for safe, individualized activity resumption.