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

Gill Hubbard; Rebecca J Beeken; Claire Taylor; Raymond Oliphant; Angus J M Watson; Julie Munro; Sarah Russell; William Goodman

doi:10.1186/s40814-020-00674-2

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

Pilot Feasibility Stud. 2020 Sep 24:6:142. doi: 10.1186/s40814-020-00674-2. eCollection 2020.

Authors

Gill Hubbard¹, Rebecca J Beeken², Claire Taylor³, Raymond Oliphant⁴, Angus J M Watson⁴, Julie Munro¹, Sarah Russell⁵, William Goodman⁶

Affiliations

¹ Department of Nursing and Midwifery, University of the Highlands and Islands, Centre for Health Science, Old Perth Road, Inverness, IV2 3JH UK.
² Leeds Institute of Health Sciences, University of Leeds, Worsley Building, Clarendon Way, Leeds, LS2 9NL UK.
³ St Mark's Hospital, London North West University Healthcare NHS Trust, Harrow, Middlesex, HA1 3UJ UK.
⁴ Department of Surgery, Raigmore Hospital, NHS Highland, Old Perth Rd, Inverness, IV2 3UJ UK.
⁵ Farmside House, Tidebrook, East Sussex, TN5 6PE UK.
⁶ Research Department of Behavioural Science and Health, University College London, Gower Street, London, WC1E 6BT UK.

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 sampleThere 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 designThis 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.InterventionA theoretically informed physical activity intervention was done, targeting people with PSH.Main outcome of feasibility studyThe main outcome is the decision by an independent Study Steering Committee whether to proceed to a full randomised controlled trial of the intervention.Other outcomesWe 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): I.Diagnosis and classification of PSHII.Muscle activationIII.Body composition (BMI, waist circumference)IV.Patient reported outcomes: QoL, body image and physical functioningV.Physical activity;VI.Psychological determinants of physical activityOther dataIncluded are other data such as interviews with all participants about the intervention and trial procedures.Data analysis and statistical powerAs 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.

Keywords: Bowel disease; Colostomy; Feasibility study; Ileostomy; Parastomal hernia.