Hernia active living trial: HALT
Not Applicable
Completed
- Conditions
- Stoma, parastomal herniaDigestive System
- Registration Number
- ISRCTN15207595
- Lead Sponsor
- niversity of the Highlands and Islands
- Brief Summary
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32983558/ protocol (added 30/09/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37400863/ (added 04/07/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
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
1. Previous parastomal hernia repair
2. Urostomy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method <br> At baseline (T0) and post-intervention 12weeks (T1):<br> 1. Diagnosis and classification of PSH measured using clinical examination<br> 2. Muscle activation measured using electromyography (EMG)<br> 3. Body composition:<br> 3.1. Waist circumference (cm)<br> 3.2. BMI (kg/m²) measured using TANITA scales (weight) and Stadiometer (height)<br> 4. Patient reported outcomes:<br> 4.1. QoL measured using Stoma-QoL and EQ-5D<br> 4.2. Body image measured using the body image scale<br> 4.3. Physical functioning measured using the patient specific function scale<br> 5. Physical Activitymeasured using the Actigraph GT3X+ accelerometer<br> 6. Psychological determinants of physical activity measured using:<br> 6.1. Basic psychological needs in exercise scale<br> 6.2. Exercise self-efficacy questionnaire<br>