HALT (Hernia Active Living Trial): protocol for a feasibility study of a randomised controlled trial of a physical activity intervention to improve quality of life in people with bowel stoma with a bulge/parastomal hernia

Abstract

Background

Parastomal hernia (PSH) can be repaired surgically, but results to date have been disappointing, with reported recurrence rates of 30 to 76%. Other types of intervention are therefore needed to improve the quality of life of people with PSH. One potential intervention is physical activity. We hypothesise that the intervention will increase core activation and control across the abdominal wall at a site of potential weakness and thus reduce the risk of PSH progression. Increases in physical activity will improve body image and quality of life (QoL).

Methods

Subjects and sample

There were approximately 20 adults with a bowel stoma and PSH. People with previous PSH repair will be excluded as well as people who already do core training.

Study design

This is a feasibility study of a randomised controlled trial with 2 months follow-up, in 2 sites using mixed methods. Stage 1 involves intervention development and in stage 2, intervention and trial parameters will be assessed.

Intervention

A theoretically informed physical activity intervention was done, targeting people with PSH.

Main outcome of feasibility study

The main outcome is the decision by an independent Study Steering Committee whether to proceed to a full randomised controlled trial of the intervention.

Other outcomes

We will evaluate 4 intervention parameters—fidelity, adherence, acceptability and safety and 3 trial parameters (eligible patients’ consent rate, acceptability of study design and data availability rates for following endpoints):

1. I.

Diagnosis and classification of PSH

2. II.

Muscle activation

3. III.

Body composition (BMI, waist circumference)

4. IV.

Patient reported outcomes: QoL, body image and physical functioning

5. V.

Physical activity;

6. VI.

Psychological determinants of physical activity

Other data

Included are other data such as interviews with all participants about the intervention and trial procedures.

Data analysis and statistical power

As this is a feasibility study, the quantitative data will be analysed using descriptive statistics. Audio-recorded qualitative data from interviews will be transcribed verbatim and analysed thematically.

Discussion

The feasibility and acceptability of key intervention and trial parameters will be used to decide whether to proceed to a full trial of the intervention, which aims to improve body image, quality of life and PSH progression.

Trial registration

ISRCTN15207595