Hernia Active Living Trial (HALT): a feasibility study of a physical activity intervention for people with a bowel stoma who have a parastomal hernia/bulge

Background

Parastomal bulging/hernia is a common complication associated with a stoma. Strengthening of the abdominal muscles via exercise may be a useful self-management strategy. The aim of this feasibility work was to address uncertainties around testing a Pilates-based exercise intervention for people with parastomal bulging.

Methods

An exercise intervention was developed and tested in a single-arm trial (n = 17 recruited via social media) followed by a feasibility randomised controlled trial RCT (n = 19 recruited from hospitals). Adults with an ileostomy or colostomy with a bulge or diagnosed hernia around their stoma were eligible. The intervention involved a booklet, videos, and up to 12 online sessions with an exercise specialist. Feasibility outcomes included intervention acceptability, fidelity, adherence, and retention. Acceptability of self-report measures for quality of life, self-efficacy, and physical activity were assessed based on missing data within surveys pre- and post-intervention. Interviews (n = 12) explored participants’ qualitative experiences of the intervention.

Results

Nineteen of 28 participants referred to the intervention completed the programme (67%) and received an average of 8 sessions, lasting a mean of 48 min. Sixteen participants completed follow-up measures (44% retention), with low levels of missing data across the different measures, apart from body image and work/social function quality of life subscales (50% and 56% missing, respectively). Themes from qualitative interviews related to the benefits of being involved, including behavioural and physical changes in addition to improved mental health. Identified barriers included time constraints and health issues.

Conclusions

The exercise intervention was feasible to deliver, acceptable to participants, and potentially helpful. Qualitative data suggests physical and psycholosical benefits. Strategies to improve retention need to be included in a future study.

Trial registration

ISRCTN, ISRCTN15207595. Registered on 11 July 2019