None listed
Conditions
Brief summary
The study is investigating the effectiveness of pelvic floor muscle (PFM) training plus general multidisciplinary rehabilitation in patients who have undergone bowel cancer surgery. Who is it for? You may be eligible to join this study if you are aged 18 years and over, have undergone anterior resection for stage I – III bowel cancer, and are able to walk and manage self-care, out of bed more than 50% of waking hours (Eastern Cooperative Oncology Group performance status 0 – 2). Trial details Participants in this study will be randomly (by chance) divided into one of two groups. Participants in one group will receive general multidisciplinary rehabilitation and PFM training program. The general multidisciplinary rehabilitation will consist of a multidisciplinary group education and exercise program, which will be provided twice weekly for 8 weeks. Each session will last approximately one hour. The education component will include advice about nutrition, exercise, fatigue management and coping with stress. Information will be delivered by a range of clinicians (physiotherapists, occupational therapists, psychologists, and dieticians). The exercise component will include a general (combined aerobic and resistance) exercise training program supervised by a physiotherapist. The PFM training program will consist of physiotherapy-supervised pelvic floor muscle training sessions, and bladder and bowel function advice over 12 sessions. Biofeedback will be used to facilitate pelvic floor muscle function. The training sessions will be approximately one hour long. The duration of intervention is eight weeks. Participants in the second group will only receive the general multidisciplinary rehabilitation twice weekly for 8 weeks. All participants will be required to complete some questionnaires and tests (e.g. transperineal ultrasound, six-minute walk test, etc) at the end of the intervention, and at 6, 12, 24 and 60 months from baseline to evaluate their pelvic floor symptoms and outcomes.
Interventions
The intervention is general rehabilitation plus pelvic floor muscle training program. The general rehabilitation will consist of a multidisciplinary education and exercise program, which will be provided as group sessions twice weekly for 8 weeks . Each session will last approximately one hour. The education component will include advice about nutrition, exercise, fatigue management and coping with stress and will be provided in a group format. Information will be delivered by a range of clinici
The intervention is general rehabilitation plus pelvic floor muscle training program. The general rehabilitation will consist of a multidisciplinary education and exercise program, which will be provided as group sessions twice weekly for 8 weeks . Each session will last approximately one hour. The education component will include advice about nutrition, exercise, fatigue management and coping with stress and will be provided in a group format. Information will be delivered by a range of clinicians (physiotherapists, occupational therapists, psychologists, and dieticians). The exercise component will include an exercise training program supervised by a physiotherapist. The pelvic floor muscle training program will consist of physiotherapy-supervised pelvic floor muscle training sessions and bladder and bowel function advice over 12 sessions, twice weekly for 6 weeks. The training program will use a combination of 7 individual and 5 group sessions. Biofeedback will be used to facilitate pelvic floor muscle function. The training sessions will be approximately one hour long. The duration of intervention is eight weeks. To encourage adherence to the intervention protocols, telephone calls from a physiotherapist and a self report diary to record training adherence will be provided.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who have undergone anterior resection for histologically confirmed, stage I-III colorectal cancer; have an Eastern Cooperative Oncology Group performance status of between 0-2 (0 = fully active, 2 = up and about for 50% of a day); and have sufficient English language skills to participate
Exclusion criteria
Patients who are pregnant or up to 12 months postpartum, have a permanent ostomy, have severe physical/psychiatric impairments, presence of other malignancies or have received post-operative supervised exercise or rehabilitation in the preceeding 12 months
Outcome results
None listed