HALT - Hernia Active Living Trial
Research type
Research Study
Full title
HALT - Hernia Active Living Trial - A feasibility study of a randomised controlled trial of a physical activity intervention to improve quality of life in people with a bowel stoma who have a bulge/parastomal hernia.
IRAS ID
269384
Contact name
Gill Hubbard
Contact email
Sponsor organisation
University of the Highlands and Islands
ISRCTN Number
ISRCTN15207595
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Summary of Research
Can a specialist physical activity intervention improve the quality of life of people living with a parastomal hernia? A feasibility trial.\nPeople who have surgery for a stoma due to bowel disease, have a risk of developing a parastomal hernia (PSH) or bulge around their stoma. This is because the surgery weakens the area and effects how the muscle around the stoma works and performs.\nWe believe that a programme that includes core exercise training will help to improve this weakness by showing people how to reactivate these muscles, allowing better core control. This should help to strengthen the natural corset-like structure of the abdominal and pelvic region. We think that this may reduce the risk of a hernia getting worse, and improve patient quality of life (QoL) and body image. Before we do a large trial, we will run this smaller trial to see if it is acceptable and safe for patients, and if they are interested in being involved.\nWe will invite any person who has a bulge/PSH to take part if they are >3-months post-surgery to take part in a 12-week physical activity intervention.\nThe intervention will involve seeing a clinical exercise specialist once a week for 12 weeks for core-exercise training. Sessions will be delivered via a range of face-to-face, telephone, and video calls. \nWe will ask patients to complete questionnaires before, and after the intervention. We will ask them to keep an exercise diary, and to wear an activity monitor. We will be inviting patients from NHS Highland, and Leeds Teaching Hospitals NHS Trust. \n
Summary of Results
Parastomal bulging/hernia is a common complication of having a stoma. Using exercise to strengthen the stomach muscles may be useful for some people. The aim of this project was to test a Pilates-based programme for people with a parastomal bulge.
Adults with an ileostomy or colostomy with a bulge or diagnosed hernia around their stoma were asked to take part. A programme was created and tested in 17 people, and then 19 people in a trial project where some received the exercise programme, and some received their usual care. The intervention involved a booklet, videos and up to 12 online sessions with an exercise specialist. We looked at how acceptable the programme was, how many people wanted to take part, and how many finished the programme. We also asked questions on quality of life, and about confidence to exercise. We also interviewed 12 people who took part to get their feedback on the programme.
Results: 19 out of 28 people completed the programme (67%), and received on average 8 sessions, lasting a mean of 48 minutes. 16 people answered all the questions we asked. In our interviews people told us about changes in their hernia, their confidence to exercise, and effects of their physical and mental health. Some people told us that having enough time, and issues with their health made it difficult to take part as much as they wanted.
Conclusions: People found exercise programme was acceptable, it was safe to deliver and potentially helpful to them. The team are now looking at ways to help people complete the questions we ask them as part of the project.REC name
North of Scotland Research Ethics Committee 1
REC reference
20/NS/0007
Date of REC Opinion
3 Feb 2020
REC opinion
Favourable Opinion