Hernia active living trial: HALT

Conditions

Stoma, parastomal hernia Digestive System Stoma, parastomal hernia

Munro J, Goodman W, Oliphant R, Russell S, Taylor C, Beeken RJ, Hubbard G.

2023-07-034 citations

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 Watson et al. (8 authors)

Pilot and Feasibility Studies2020-09-2410 citations

10.1186/s40814-020-00674-2

Interventions

A theoretically informed 12 week physical activity intervention with a clinical exercise specialist. Control group will receive usual care. Intervention Group - The intervention will

based on our previous study the average range is likely to be 15 - 45 mins (min 5

max 12

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Stoma and diagnosed with a parastomal hernia, or has a bulge at the stoma site 2. >12 weeks post surgery

Exclusion criteria

Exclusion criteria: 1. Previous parastomal hernia repair 2. Urostomy

Design outcomes

Primary

Measure	Time frame
Decision to proceed with a full-scale RCT of the intervention. An independent steering group committee will recommend whether the findings support the progression on to a fully powered trial.	—

Secondary

Measure	Time frame
At baseline (T0) and post-intervention 12weeks (T1): 1. Diagnosis and classification of PSH measured using clinical examination 2. Muscle activation measured using electromyography (EMG) 3. Body composition: 3.1. Waist circumference (cm) 3.2. BMI (kg/m²) measured using TANITA scales (weight) and Stadiometer (height) 4. Patient reported outcomes: 4.1. QoL measured using Stoma-QoL and EQ-5D 4.2. Body image measured using the body image scale 4.3. Physical functioning measured using the patient specific function scale 5. Physical Activity measured using the Actigraph GT3X+ accelerometer 6. Psychological determinants of physical activity measured using: 6.1. Basic psychological needs in exercise scale 6.2. Exercise self-efficacy questionnaire	—

Measure

Time frame

At baseline (T0) and post-intervention 12weeks (T1): 1. Diagnosis and classification of PSH measured using clinical examination 2. Muscle activation measured using electromyography (EMG) 3. Body composition: 3.1. Waist circumference (cm) 3.2. BMI (kg/m²) measured using TANITA scales (weight) and Stadiometer (height) 4. Patient reported outcomes: 4.1. QoL measured using Stoma-QoL and EQ-5D 4.2. Body image measured using the body image scale 4.3. Physical functioning measured using the patient specific function scale 5. Physical Activity measured using the Actigraph GT3X+ accelerometer 6. Psychological determinants of physical activity measured using: 6.1. Basic psychological needs in exercise scale 6.2. Exercise self-efficacy questionnaire

—

Countries

England, Scotland, United Kingdom

Contacts

Public ContactGill Hubbard

gill.hubbard@uhi.ac.uk+44 (0)1463 279815

Outcome results

None listed