A Multicentre, Pilot Randomized Controlled Trial to Examine the Effects of Prehabilitation on Functional Outcomes After Radical Prostatectomy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Study Retention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with localized prostate cancer (stage cT1- cT2) who have consented for radical prostatectomy
- •between the ages of 40 and 80 years.
排除标准
- •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).
研究组 & 干预措施
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.
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.
干预措施: Prehabilitation (PREHAB) (Behavioral)
结局指标
主要结局
Study Retention
时间窗: 26 weeks postoperatively
Retention will be assessed by measuring attrition throughout the intervention period and at each assessment.
Contamination
时间窗: 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.
Recruitment
时间窗: 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
时间窗: 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.
次要结局
- Treatment Complications(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.)
- Length of stay(From time of surgery to discharge (typically 1 week))
- Physical Fitness(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.)
研究者
Daniel Santa Mina
Program Head
University of Guelph-Humber