Trimodal Prehabilitation for Cystectomy Patients to Enhance Post-operative Care: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- 6-minute walk test (6MWT)
研究概览
简要总结
Trimodal prehabilitation is a preoperative three-tiered (trimodal) approach to optimizing physical and mental health. It has been found to successfully improve functional recovery in patients undergoing colorectal surgery following an evidence-based enhanced-recovery pathway (ERP). It is unknown whether the same program is effective in patients undergoing a similar surgery for bladder cancer (radical cystectomy).
Objective: To evaluate the appropriateness of a standardized prehabilitation program for implementation into an enhanced recovery pathway for cystectomy patients and determine whether prehabilitation facilitates earlier recovery of functional capacity.
Hypothesis: Prehabilitation will ultimately improve recovery of functional capacity, clinical and patient-centered outcomes in patients undergoing radical cystectomy for bladder cancer.
Design: Participants will follow an 8-week trimodal prehabilitation program consisting of exercise therapy combined with nutritional counseling, protein supplementation, and psychological care; they will be compared to a cohort of participants following ERP care alone.
Conclusion: The proposal will provide insight into the feasibility and effectiveness of trimodal prehabilitation for radical cystectomy patients and may ultimately lead to improved clinical outcomes and reduced morbidity.
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
- Single (Outcomes Assessor)
盲法说明
Assessor blinding; due to the nature of the study, participant, care provider & investigator cannot be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years of age at time of consent for surgery.
- •Documentation of bladder cancer diagnosis as evidenced by diagnostic imaging and biopsy.
- •May or may not receive adjuvant therapy.
- •Written informed consent obtained from subject
排除标准
- •Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or adherence to the program. This includes:
- •American Society of Anesthesiologists (ASA) health class status 4-5;
- •Co-morbid medical, physical, and/or mental conditions including dementia, disabling orthopedic and neuromuscular disease, psychosis;
- •Severe cardiac abnormalities, end-stage organ disease, sepsis, or morbid obesity (BMI greater than 35);
- •Undergoing radical cystectomy for a reason other than bladder cancer.
- •Poor comprehension of English or French
- •Screened by Total Cardiology staff and determined to be inappropriate for prehabilitation at their facility.
研究组 & 干预措施
Trimodal Prehab & ERP
Trimodal prehab includes:
- Guided exercise program at Repsol Place in Calgary, Alberta 2x/week, hosted by the Total Cardiology group. Home-exercise program for another 3x/week.
- Nutritional optimization with a high-protein oral supplement, along with nutritional counseling and access to a Registered Dietitian on site.
- Anxiety reduction workshop and take-home anxiety reduction program.
干预措施: Trimodal Prehab & ERP (Combination Product)
No Prehab; ERP Alone
The active comparator group will be given a home exercise program, nutrition education, and a take-home anxiety reduction program.
干预措施: No Prehab; ERP Alone (Other)
结局指标
主要结局
6-minute walk test (6MWT)
时间窗: Multiple time-points over 20-weeks
The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
次要结局
- 30s sit-to-stand test (30CST)(Multiple time-points over 20-weeks)
- Hand-grip dynamometry(Multiple time-points over 20-weeks)
- 10-meter walk test (10mWT)(Multiple time-points over 20-weeks)
- Functional Assessment of Cancer Therapy for Bladder Cancer (FACT-Bl)Questionnaire(Collected at beginning and end of 20-week participant involvement period)
- EuroQOL five dimensions (EQ-5D) Questionnaire(Collected at beginning and end of 20-week participant involvement period)
- Godin Leisure Time Exercise Questionnaire(Collected at beginning and end of 20-week participant involvement period)
研究者
Jason Martyn
Physiotherapist
Alberta Health Services, Calgary