Impact of a Multimodal Prehabilitation Program Before Robotic-assisted Radical Prostatectomy. A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Perioperative anxiety levels
研究概览
简要总结
The aim of the study is to verify whether a multimodal prehabilitation programme prior to robotic radical prostatectomy contributes to a faster recovery of quality of life after surgery, to better functional results (including erectile function and continence) and to less perioperative anxiety.
详细描述
Single center randomized clinical trial including prostate cancer patients undergoing robotic-assisted radical prostatectomy at the Hospital Clínic de Barcelona. Patients will be randomized into two groups, one receiving multimodal prehabilitation and the other a control group. Multimodal prehabilitation consists of improving the functional and mental capacity of an individual to cope with a significant stressor, in this case surgery. The design of our prehabilitation program, lasting 4 weeks prior to surgery, consists of three parts; physical state, nutritional state and mental health. In the case of physical condition, a series of supervised and "home-based" exercises (aerobic and functional) will be carried out in addition to specific pelvic floor exercises. The nutritional status will be evaluated by a nutritionist. Diet guidelines will be given and if there are deficiencies they will be supplemented. Regarding mental health, a visit will be made with a psychologist and group and online therapies will be offered. The outcomes will be evaluated before starting the prehabilitation program, at the end of it (just before surgery) and at 4, 8 and 16 weeks after surgery. The outcomes include variables on physical, nutritional and mental state, health-related quality of life (HRQoL), and continence and erectile function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with localized prostate cancer
- •Candidates to robotic radical prostatectomy
排除标准
- •Non-localized prostate cancer
- •Previous history of pelvic radiotherapy or pelvic surgery
- •Failure to consent,
- •Unwillingness to participate
- •Anticipated failure to adhere to the program sessions.
结局指标
主要结局
Perioperative anxiety levels
时间窗: Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op)
Change in perioperative anxiety levels Hospital Anxiety \& Depression (HAD ) Scoring scale: 0-21 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
Continence recovery
时间窗: Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op)
Change in continence during the prehabilitation program and postoperative recovery. International Consultation on Incontinence Questionnaire (ICIQ) Scoring scale: 0-21 Higher value means worse outcome
次要结局
- Change in physical status by STS(Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op))
- Perceived application usability(Week 4)
- Change in physical status by 6MWT(Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op))
- Erectile function recovery(Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op))
- Change in perceived general quality of life(Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op))
- Early postoperative morbidity by CCI(Week 8 (post-op))
- Change in perception of physical status(Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op))
- Change in perceived prostate quality of life(Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op))
- Early postoperative morbidity by CDC(Week 8 (post-op))
- Nutritional status(Week 0 and 4)
- Satisfaction with the multimodal program(Week 4)