None listed
Conditions
Brief summary
This multi-site randomised controlled trial will test whether adding an online stoma-specific core-strengthening exercise program, Convatec Me+Recovery®, to standard stoma support garment use helps prevent parastomal hernia or delays the time to parastomal hernia after stoma formation. The study will recruit 450 adults with a new stoma across Australian hospitals/services. Participants will be randomly allocated 1:1 to either stoma support garment alone or stoma support garment plus the Convatec Me+Recovery® program. Participants will complete monthly online surveys and attend routine Stomal Therapy Nurse reviews for up to 24 months. The main outcome is time to diagnosis of parastomal hernia.
Interventions
Participants allocated to the intervention group will receive a stoma support garment plus access to the Convatec Me+Recovery® program. The support garment will be fitted by the site Stomal Therapy Nurse as soon as clinically appropriate after stoma formation, either before hospital discharge or at the first post-operative Stomal Therapy Nurse clinic visit. The garment will be selected and fitted according to usual clinical practice and the Stomal Therapy Nurse’s clinical judgement. Participants will be encouraged to wear the garment while upright each day for the 24-month follow-up period, or as clinically appropriate. In addition, participants will be directed to access the online Convatec Me+Recovery® program, a free, structured, stoma-specific abdominal and core recovery program for people living with a stoma. The program is delivered online using the participant’s own internet-enabled device. The program includes gentle, staged abdominal/core recovery movements. Examples include abdominal breathing, pelvic tilts, gentle abdominal/core activation, knee rolls, heel slides, seated or standing abdominal activation exercises, and gradual progression to more challenging core movements as tolerated. Participants will be encouraged to complete short exercise modules of approximately 10–15 minutes, 2–3 times per week, for the duration of the 24-month follow-up period, or as tolerated. Exercise intensity is expected to be low to low-moderate because the program is based on gentle recovery movements and progressive abdominal/core strengthening rather than vigorous aerobic or resistance exercise. Intensity will not be prescribed using heart rate or external load. Tolerability will be assessed by participant self-report through monthly REDCap surveys, including frequency and duration of exercise sessions, whether exercises were completed as planned, barriers to participation, symptoms or discomfort during or after exercise, and whether exercises were paused or stopped. Participants may progress through the program at their own pace. They will be advised to pause or stop exercises if they experience pain, discomfort, new or worsening abdominal/stomal symptoms, problems with the stoma appliance, or if advised to stop by their treating team. Participants reporting concerning symptoms will be advised to contact their Stomal Therapy Nurse or treating clinical team. Exercise program participation and adherence will be monitored through monthly online self-report surveys.
Sponsors
Study design
Eligibility
Inclusion criteria
Adults aged 18 years and over following formation of a new stoma. Able to give informed consent. Willing to participate in the study. Has internet access and a suitable device, such as a smartphone, tablet, laptop or desktop computer, capable of streaming short instructional videos and completing web-based forms. Willing and able to receive and respond to electronic correspondence. Sufficient English language proficiency to complete online surveys and follow the Convatec Me+Recovery® program if randomised to that arm.
Exclusion criteria
Palliative patients. Significant comorbidities preventing participation. Unable to give informed consent. No internet access or suitable device, such as a smartphone, tablet, laptop or desktop computer, capable of streaming short instructional videos and completing web-based forms. Unwilling to participate in the Convatec Me+Recovery® program if randomised to that arm.