Prehabilitation for Prostate Cancer Surgery

NCT02036684 | Completed Phase 1

• 1 other identifier: D-201327
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer Patients Undergoing Radical Prostatectomy

Keywords

Prostate cancer; Radical prostatectomy; Prehabilitation; Pelvic floor muscle exercises

Outcome Measures

Primary Outcomes (4)

• Recruitment

  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.

  When recruitment is complete (approximately 12 months after study initiation; January 2015)

• Adherence to Prehabilitation Program

  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.

  26 weeks postoperatively

• Contamination

  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.

  26 weeks postoperatively

• Study Retention

  Retention will be assessed by measuring attrition throughout the intervention period and at each assessment.

  26 weeks postoperatively

Secondary Outcomes (6)

• Physical Fitness

  At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.

• Quality of Life

  At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.

• Psychosocial Wellbeing

  At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.

• Physical Activity

  At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.

• Treatment Complications

  26 weeks postoperatively

Study Arms (2)

Healthy Lifestyle Booklet

NO INTERVENTION

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.

Prehabilitation (PREHAB)

EXPERIMENTAL

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)

Interventions

Prehabilitation (PREHAB) BEHAVIORAL

Prehabilitation (PREHAB)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Guelph-Humber: lead
• University Health Network, Toronto: collaborator
• Princess Margaret Hospital, Canada: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (2)

University Health Network

Toronto, Ontario, M5G2C4, Canada

Location

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (2)

• Au D, Matthew AG, Lopez P, Hilton WJ, Awasthi R, Bousquet-Dion G, Ladha K, Carli F, Santa Mina D. Prehabilitation and acute postoperative physical activity in patients undergoing radical prostatectomy: a secondary analysis from an RCT. Sports Med Open. 2019 May 22;5(1):18. doi: 10.1186/s40798-019-0191-2.

  PMID: 31119491 DERIVED

• Santa Mina D, Matthew AG, Hilton WJ, Au D, Awasthi R, Alibhai SM, Clarke H, Ritvo P, Trachtenberg J, Fleshner NE, Finelli A, Wijeysundera D, Aprikian A, Tanguay S, Carli F. Prehabilitation for men undergoing radical prostatectomy: a multi-centre, pilot randomized controlled trial. BMC Surg. 2014 Nov 13;14:89. doi: 10.1186/1471-2482-14-89.

  PMID: 25394949 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Head

Study Record Dates

• First Submitted: November 16, 2013
• First Posted: January 15, 2014
• Study Start: November 1, 2013
• Primary Completion: May 17, 2016
• Study Completion: May 17, 2016
• Last Updated: August 23, 2017

Record last verified: 2017-08

Locations

CA (2)