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Prehabilitation for Prostate Cancer Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02036684
First Posted: January 15, 2014
Last Update Posted: August 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University Health Network, Toronto
Princess Margaret Hospital, Canada
McGill University Health Center
Information provided by (Responsible Party):
Daniel Santa Mina, University of Guelph-Humber
  Purpose
Radical prostatectomy is the most common and effective treatment for localized prostate cancer. Unfortunately, radical prostatectomy is associated with significant adverse effects, such as urinary incontinence, sexual dysfunction, and reduced physical function that collectively diminish health-related quality of life which may persist for up to two years postoperatively. The primary objective of this trial is to assess the feasibility of conducting of a multi-site randomized controlled trial to test the effect of a comprehensive prehabilitation program versus standard care for men with prostate cancer undergoing radical prostatectomy. We hypothesize that men with prostate cancer undergoing radical prostatectomy in the comprehensive prehabilitation program (full-body exercises and pelvic floor muscle exercises) will report better health-related quality of life, urological symptoms, and physical fitness, physical activity, and pain, as well as a shorter postoperative length of stay than participants receiving standard preoperative care (pelvic floor muscle exercises alone). Our secondary objective is to report estimates of efficacy on several clinically important outcomes for this population that will be used for sample size calculations in an adequately powered trial.

Condition Intervention Phase
Prostate Cancer Patients Undergoing Radical Prostatectomy Behavioral: Prehabilitation (PREHAB) Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:


Further study details as provided by Daniel Santa Mina, University of Guelph-Humber:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 86
Study Start Date: November 2013
Study Completion Date: May 17, 2016
Primary Completion Date: May 17, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men with localized prostate cancer (stage cT1- cT2) who have consented for radical prostatectomy
  • between the ages of 40 and 80 years.

Exclusion Criteria:

  • i) severe coronary artery disease (Canadian Cardiovascular Society class III or greater);
  • ii) significant congestive heart failure (New York Heart Association class III or greater);
  • iii) uncontrolled pain;
  • iv) neurological or musculoskeletal co-morbidity inhibiting exercise;
  • v) diagnosed psychotic, addictive, or major cognitive disorders;
  • vi) no more than two of the following Coronary Risk Factors as defined by the American College of Sports Medicine : family history of coronary disease, cigarette smoking, hypertension (SBP > 140 mmHg; DBP > 90 mmHg), known dyslipidemia, known impaired fasting, glucose (>110 mg/dL), obesity (BMI > 30 kg/m2 or waist circumference > 102cm), or physically inactive (<150 min of moderate intensity physical activity per week).
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G2C4
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
University of Guelph-Humber
University Health Network, Toronto
Princess Margaret Hospital, Canada
McGill University Health Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel Santa Mina, Program Head, University of Guelph-Humber
ClinicalTrials.gov Identifier: NCT02036684     History of Changes
Other Study ID Numbers: D-201327
First Submitted: November 16, 2013
First Posted: January 15, 2014
Last Update Posted: August 23, 2017
Last Verified: August 2017

Keywords provided by Daniel Santa Mina, University of Guelph-Humber:
Prostate cancer
Radical prostatectomy
Prehabilitation
Pelvic floor muscle exercises

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases


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