Abstract
BackgroundPhysical activity (PA) is positively associated with quality of life. People with a stoma are less likely to engage in PA than those without a stoma.MethodsIn this feasibility intervention study, we will perform the following: (1) Develop a PA intervention for people with a stoma. An Expert Working Group of behavioural scientists, exercise scientists, clinicians and a Patient Advisory Group of people with a bowel stoma will meet with the research team to inform the development of a PA intervention for people with a stoma. A manual of the intervention will be the main output. (2) Explore PA instructors’ experiences of delivering the PA intervention. PA instructors will record on paper the number of PA consultations with each patient and a researcher will interview the PA instructors about their experiences of delivering the intervention. (3) Assess the level of patient (bowel cancer or inflammatory bowel disease (IBD) patients with a stoma between 6 weeks and 24 months post-surgery) engagement with the PA intervention and their views on intervention acceptability and usefulness. Patients will keep a PA diary to record daily pedometer recorded step count and type and duration of activities. A researcher will interview patients about their experiences of the PA intervention. (4) Assess screening, eligibility, consent, data completion, loss to follow up, and missing data rates, representativeness of participants and potential treatment effects. A researcher will record on paper all study procedure parameters. Quality of life (stoma-quality of life; Functional Assessment of Cancer Therapy, Short IBD questionnaire), fatigue (FACIT fatigue scale) and PA (accelerometer) will be measured pre- and post-intervention in patients. For IBD patients only, blood will be taken to measure systemic inflammation.DiscussionWe hypothesise that a PA intervention will be an effective means of improving the quality of life of people with a stoma. Before embarking on a full randomised controlled trial to test this hypothesis, a PA intervention needs to be developed and a feasibility study of the proposed PA intervention conducted.Trial registrationISRCTN58613962, Protocol version: 0.1. 14 September 2017.
Highlights
Physical activity (PA) is positively associated with quality of life
We hypothesise that a PA intervention will be an effective means of improving the quality of life of people with a stoma
Aim We hypothesise that a PA intervention will be an effective means of improving the quality of life of people with a stoma
Summary
Physical activity (PA) is positively associated with quality of life. People with a stoma are less likely to engage in PA than those without a stoma. This article presents a research protocol for a feasibility study of a physical activity (PA) intervention to improve the quality of life in patients with a bowel stoma. The two types of eliminating bowel stomas are colostomy and ileostomy, which can be temporary or permanent [2]. In Europe, approximately 700,000 people are living with a stoma, and in the USA, more than 1 million people have a stoma [3]. It is estimated that there are 100,000 people with stomas in the UK [4]. There are a number of conditions that may necessitate the formation of a bowel stoma including bowel cancer and inflammatory bowel
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