Prehabilitation Before Surgery in Colorectal Cancer With Improved Fast Track Rehabilitation : Part 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in cardiorespiratory fitness
研究概览
简要总结
Objectives To investigate the impact of tele-supervised prehabilitation on functional capacity in colon cancer patients undergoing colorectal resection for cancer and to evaluate the effects of prehabilitation on muscle strength and endurance, quality of life (QoL), executive functions, fatigue and inflammatory and metabolic parameters.
Methods A randomized controlled trial will be conducted. Patients will be randomised into either a prehabilitation group or a control group. The prehabilitation group will receive tele-supervised prehabilitation for 4weeks and telerehabilitation for 8weeks post-surgery while control group will begin telerehabilitation only after surgery for 8weeks. Patients will care with an enhanced recovery pathway. Telerehabilitation pre and post-surgery will consist of three moderate-intensity aerobic and resistance sessions per week. Subjects will be assessed at baseline, pre-intervention, post-intervention and post-rehabilitation. The primary outcome will be functional capacity measured using the 6-min walk test. The secondary outcomes will be: physical measurement, quality of life, level of physical activity, executive functions, fatigue, body composition, blood test, energy expenditure.
详细描述
Study objectives Primary objective: The investigators want to assess if a tele-supervised prehabilitation improves preoperative cardio-respiratory fitness in colon cancer patients in the setting of an enhanced recovery pathway.
Secondary objectives
- The investigators want to examine if this tele-supervised prehabilitation has beneficial effects on muscle strength and endurance, on quality of life, on executive functions, on fatigue, on inflammatory parameters and on metabolic disruption pre-surgery.
- The investigators want to determine whether changes in the preoperative period remain in the postoperative period after 8 weeks of telerehabilitation.
Rationale and scientific background:
In Belgium, colon cancer is the third most common cancer in men and the second most common in women and is the second cause of cancer death. Surgery is currently the primary treatment for stage I to III. This surgery benefits from several years of multimodal program, commonly called "Fast Track" program or enhanced recovery. Nowadays, the lack of preoperative fitness is not specifically taken into account in the Fast Track program. Nevertheless, studies have shown that patients with poor preoperative physical fitness are less able to cope with the adverse effects of surgery and hospitalization resulting in increased risk of mortality, postoperative complications and functional recovery time. It seems relevant to intervene during the preoperative period to improve the patient's functional capacity before the surgery, via physical training to overcome the stress of the surgery and to improve postoperative recovery. This process is called "prehabilitation" Structured and supervised programs have shown to be effective and feasible. However, time, resources, expensive care are often a barrier for the patient. Thereby, a home-based tele-supervising rehabilitation would be an attractive therapeutic option to offer a distinct advantage in this regard. More specifically, "telerehabilitation can be defined as the application of telecommunication, remote sensing and operation technologies, and computing technologies to assist with the provision of medical rehabilitation services at a distance".
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)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of colon cancer requiring surgery;
- •more than 40 years of age;
- •autonomous and voluntary person;
- •able to read, write and understand French;
- •Frailty phenotype criteria < 3
排除标准
- •a physical impairment that would seriously impair physical mobility;
- •an unfavorable familial context;
- •American Society of Anesthesiologists score IV-V;
- •emergency;
- •neuropsychiatric disease.
结局指标
主要结局
Change in cardiorespiratory fitness
时间窗: Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation
Cardiorespiratory is measured by a 6-minute walk test
次要结局
- Change in muscle strength(Assessments at baseline, one day before the surgery, immediately after the rehabilitation)
- Change in muscle endurance(Assessments at baseline, one day before the surgery, 1week after the surgery and immediately after the rehabilitation)
- Change in quality of life(Assessments at baseline, one day before the surgery, 1week after the surgery and immediately after the rehabilitation)
- Change in fatigue(Assessments at baseline, one day before the surgery, 1week after the surgery and immediately after the rehabilitation)
- Change in Fasting glucose(Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation)
- Change in Fasting insulin(Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation)
- Change in executive functions(Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation)
- Change in level of physical activity(Assessments at baseline, one day before the surgery, 1week after the surgery and immediately after the rehabilitation)
- Change in weight(Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation)
- Change in lean body mass(Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation)
- Change in fat body mass(Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation)
- Energy expenditure(During 7 days before the surgery and during 7 days after the surgery)
- Change in cholesterol(Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation)
- Change in neutrophil/lymphocyte(Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation)
- Change in C-reactive protein(Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation)
- Adherence(Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation)
研究者
G.Reychler
Principal Investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain