Prehabilitation for Prostate Cancer Surgery
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|ClinicalTrials.gov Identifier: NCT02036684|
Recruitment Status : Completed
First Posted : January 15, 2014
Last Update Posted : August 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Patients Undergoing Radical Prostatectomy||Behavioral: Prehabilitation (PREHAB)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Multicentre, Pilot Randomized Controlled Trial to Examine the Effects of Prehabilitation on Functional Outcomes After Radical Prostatectomy|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||May 17, 2016|
|Actual Study Completion Date :||May 17, 2016|
No Intervention: Healthy Lifestyle Booklet
Standard care for radical prostatectomy (RP) patients includes the provision of preoperative information from a urology nurse educator. Usual care (UC) participants will be given generic instructions by the research coordinator about pelvic floor muscle exercises (PFMX), mobilization and general timeframes for a return to normal activities. The UC group will receive the same PFMX prescription as the PREHAB (Experimental) group and will receive weekly communication from the research coordinator regarding compliance with the PFMX prescription to provide an attentional-control. These instructions are provided in a healthy lifestyle booklet for men with prostate cancer.
Experimental: Prehabilitation (PREHAB)
The prehabilitation (PREHAB) program focuses on total-body physical exercises and pelvic floor muscle exercises (PFMX). The total-body exercise prescription will consist of 60 minutes of home-based, unsupervised exercise on 3-4 days per week, alternating between aerobic and resistance training. Each session will include: a 5-minute warm-up, 25 minutes of aerobic exercise, 25 minutes of resistance training (5 exercises targeting major muscle groups), and a 5-minute cool-down. Training intensity progression will occur throughout the intervention. Participants will be provided with resistance bands, a stability ball, and an exercise mat. The PFMX prescription will include a gradual increase in PFMX exercises from 60 per day during weeks 1-2, 120 per day during weeks 3-4, and 180 per day during weeks 5-6 until the surgery date. The total number of repetitions of the PFMXs will be divided equally between the rhythmic and sustained contractions.
Behavioral: Prehabilitation (PREHAB)
- Recruitment [ Time Frame: When recruitment is complete (approximately 12 months after study initiation; January 2015) ]Prior exercise trials in prostate cancer patients on hormone and/or radiation therapy have observed recruitment rates of 25-40%, but no studies have assessed recruitment to a preoperative exercise intervention among prostate cancer survivors. We will measure recruitment-success percentage and will record reasons for non-participation to better understand why men electing radical prostatectomy would not participate in an exercise intervention.
- Adherence to Prehabilitation Program [ Time Frame: 26 weeks postoperatively ]Adherence to the home-based exercise program (aerobic and resistance) and pelvic floor muscle exercises will be measured through a logbook completed by the research coordinator during weekly communication.
- Contamination [ Time Frame: 26 weeks postoperatively ]The same exercise logbook questions that ask about aerobic and resistance exercise, and pelvic floor muscle exercises, will be administered to both groups to assess contamination.
- Study Retention [ Time Frame: 26 weeks postoperatively ]Retention will be assessed by measuring attrition throughout the intervention period and at each assessment.
- Physical Fitness [ Time Frame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively. ]Musculoskeletal fitness will be assessed using grip strength (hand dynamometer) and maximal upper body strength (handheld digital dynamometer). Body composition will be assessed via body mass index, waist circumference (midpoint between lowest rib and iliac crest), and body fat percentage (bioelectrical impedance analysis). Aerobic fitness is measured using the 6-Minute Walk Test.
- Quality of Life [ Time Frame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively. ]Prostate cancer-specific health related quality of life (HRQOL) will be measured using the Functional Assessment of Cancer Treatment-Prostate (FACT-P) and the Patient-Oriented Prostate Utility Scale (PORPUS).
- Psychosocial Wellbeing [ Time Frame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively. ]Depressive symptoms will be measured with the 14-item Hospital Anxiety and Depression Scale (HADS). Cancer-specific fatigue will be measured using the FACT-Fatigue which is a widely used 13-item measure with strong reliability and validity. The Pain Disability Index (PDI) will be used to assess the extent to which persistent pain interferes with an individual's ability to engage in seven different areas of everyday activity.
- Physical Activity [ Time Frame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively. ]Physical activity level will be measured through the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire. In-hospital and in-home physical activity during the acute postoperative period will be measured by the Actiwatch-64, a small wristwatch-like accelerometer device. The Actiwatch will be worn from admission to the in-patient unit until the patient returns to the hospital for catheter removal (approximately 7 days).
- Treatment Complications [ Time Frame: 26 weeks postoperatively ]The number and type of peri-operative complications will be extracted from medical records.
- Length of stay [ Time Frame: From time of surgery to discharge (typically 1 week) ]We will collect the postoperative length of stay information for all participants from the patient record.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036684
|University Health Network|
|Toronto, Ontario, Canada, M5G2C4|
|McGill University Health Centre|
|Montreal, Quebec, Canada, H3G 1A4|