Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer
- Conditions
- Prostate CancerIncontinenceMetabolic Disease
- Interventions
- Behavioral: Pelvic floor exercise programBehavioral: Physical Activity CounselingBehavioral: General exercise
- Registration Number
- NCT06072911
- Lead Sponsor
- University of Alberta
- Brief Summary
The Continence, Sexual and Metabolic Health (CONTROL 4 LIFE) study will evaluate the recovery of continence, sexual function, and health outcomes in individuals who have undergone surgery for prostate cancer. The purpose of this study is to better understand the timelines of recovery for these outcomes after surgery for prostate cancer. As part of this study, all participants will receive resources offered by Alberta Health Services regarding pre- and post-prostatectomy care, including information on pelvic floor exercises. Through the CONTROL 4 LIFE study, the investigators will also be evaluating outcomes related to physical activity, fitness and quality of life. These assessments will enable the investigators to better understand how well and how long it takes for individuals to recover after surgery for prostate cancer.
- Detailed Description
The investigators aim to conduct a trial examining the feasibility and the effects of a combined pelvic health rehabilitation and exercise program that can be delivered both in-person and virtually in individuals who have been treated with prostatectomy for prostate cancer. This hybrid format will support equitable program delivery regardless of location of residence. To address issues faced by men with prostate cancer, the investigators propose an intervention (offered virtually and in-person) that includes: 1) online education to support continence, sexual and overall health; 2) a group exercise fitness program that considers the needs and restrictions specific to the early post-prostatectomy surgical period, and 3) functional and intensive pelvic floor muscle exercise retraining to promote continence and sexual recovery.
Main objectives of this study
1. Determine the feasibility, defined as the acceptability and appropriateness, of a combined pelvic health rehabilitation and exercise fitness program that can be delivered both in-person and virtually.
2. Determine the effects of the program on the primary outcome measure of urinary continence in comparison with usual care.
Secondary objectives of this study
1. To determine the effects of the program on cardiometabolic indicators in comparison with usual care.
2. To determine the effects of the program on general fitness, secondary outcomes of urinary continence, sexual function, self-efficacy, and cancer symptom burden, in comparison with usual care.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 106
- have a diagnosis of prostate cancer (stage I to IV);
- be scheduled for a prostatectomy surgery (any surgical approach);
- have no restriction to participate in at least mild levels of physical activity, as confirmed by the Physical Activity Readiness Questionnaire (PAR-Q+);
- speak and understand English.
- adult: 18 years of age or older
- optional exercise component: willing and able to commit to the 12-week intervention
- have any medical conditions that may interfere with continence (i.e. neurological diseases);
- have any contraindications to exercise testing or training;
- have recent (>6 months) modifications to any medication aiming to reduce urinary incontinence (i.e. Myrbetric);
- do not have regular access to the internet and a smart device or a computer at home/ at their community center;
- are already receiving a pelvic floor exercise program through a pelvic floor physical therapist from their community.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Pelvic floor exercise program Pelvic floor exercises and standard care (physical activity counseling) Intervention Pelvic floor exercise program Pelvic floor exercise program and general exercise programming Control Physical Activity Counseling Pelvic floor exercises and standard care (physical activity counseling) Intervention General exercise Pelvic floor exercise program and general exercise programming
- Primary Outcome Measures
Name Time Method Completion Rate Final assessment at one year The number of participants completing the study including all planned outcomes
- Secondary Outcome Measures
Name Time Method Recruitment rate One year Percentage of participants who are eligible and agree to participate
Upper limb mobility 12 weeks Shoulder Range of Motion: mean value in degrees
Adherence rate Post-intervention: 12 weeks Adherence to the intervention components
International Consultation on Incontinence Questionnaire One-year 13 questions: occurrence and bother of lower urinary tract symptoms, quality of life; Range of scores: 0-20 voiding subscale; 0-20 incontinence symptoms; Higher scores indicate worse functioning
Edmonton Symptom Assessment Scale One year 11-item ordinal scale; Range 0-60; with higher scores indicating higher symptom burden
Self-efficacy Questionnaire: Incontinence One year 6 item ordinal scale: Range 0-60; Higher scores indicating higher self-efficacy
Expanded Prostate Cancer Index Composite for Clinical Practice One-year 16-questions: urinary function, sexual and erectile function, bowel and hormonal function; Scores: 0 (no symptoms) to 60 (most severe symptoms); Higher scores indicate worse functioning
Glucose 12-weeks mmol/L (mean value)
24-hour pad test 24 hours at two time points: immediate post surgery and 12 weeks Mean: Individual's urine loss by measuring weight (grams) of an absorbent pad
36-Item Short Form Survey One-year Quality of life measure: Items are scored 0-100 (percentage of total possible score): Higher scores equal better quality of life
Grip Strength 12 weeks Dyanometer: mean in kgs
Lower body strength 12-weeks Sit-to-stand: mean number completed in 30 seconds
Walking endurance 12-weeks Six-minute walk test: mean distance in metres
Lipid profile 12-weeks Cholesterol level: mg/dL (mean value)
Balance 12-weeks One-leg stance test: mean time in seconds
Body Mass Index 12-weeks Height and weight will be combined to calculate BMI: mean: weight in kilograms divided by height in metres squared
Insulin level 12-weeks mmol/L (mean value)
Hemoglobin A1c 12-weeks Value in percentage (mean value)
Flexibility 12-weeks Sit and reach: mean value in cm
Trial Locations
- Locations (1)
University of Alberta
🇨🇦Edmonton, Alberta, Canada