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临床试验/NCT03097224
NCT03097224Unknown不适用

Prehabilitation Before Surgery in Colorectal Cancer With Improved Fast Track Rehabilitation : Part 2

Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年4月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
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 frail colon cancer patients undergoing colorectal resection 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 (PREHAB) or a control group. Prehabilitation group will participate in a 4-week telerehabilitation before surgery while the control group will receive usual care and World Health Organization recommendations on physical activity for health before surgery. Program exercise will consist of three moderate-intensity aerobic and resistance sessions per week. Subjects will have assessments at baseline, pre-intervention and 8 weeks after surgery. The primary outcome will be functional capacity measured by using the 6-min walk test. The secondary outcomes will be: physical measurements, QoL, level of physical activity, executive functions, fatigue, body composition, blood test, energy expenditure.

详细描述

Objectives Primary objective: To assess if a 4-week tele-supervised prehabilitation is effective in improving post-operative cardio-respiratory fitness in frail colon cancer patients.

Secondary objectives : To examine if a 4-week preoperative 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.

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. 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. Moreover, approximately 60% of colon cancer patients are older than 70 years at diagnosis and more than 50% of older cancer patients have frailty or pre-frailty. Frailty is a state of vulnerability decreased functional reserve, impairment or dysregulation in several physiological systems, and reduced capacity to recover physiological homeostasis after a stress. Nowadays, no frail definition is clearly defined. One widely accepted definition uses the Fried criteria including the assessment of weight loss, physical exhaustion, physical activity level, grip strength and walking speed. Preoperative frail colon cancer patients have a significantly higher risk of adverse postoperative outcomes including institutionalization, length of stay, morbidity and mortality. 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 and 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. To date, no study has studied the effects of tele-supervised prehabilitation in these "frail" patients.

Study design A single-blind, randomized, controlled trial will be conducted. Participants will be randomized into either a prehabilitation group or a control group. An assessor who will be blinded to group allocation will collect outcomes measures for each participant.

Study sample To be eligible for this study participants will need to meet the following criteria: diagnosis of colon cancer requiring surgery; more than 65 years of age; able to read, write and understand French; Frailty phenotype criteria ≥ 3. Frailty was assessed using the components of the Frailty Phenotype, which was first developed by Fried et al., which consists of five criteria: weight loss, exhaustion, low physical activity, slowness, and weakness.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of colon cancer requiring surgery
  • More than 65 years of age;
  • Able to read, write and understand French;
  • Frailty phenotype criteria ≥ 3

排除标准

  • The participants have a physical impairment that would seriously impair physical mobility;
  • the surgery is an emergency;
  • The participants have a neuropsychiatric disease.

研究组 & 干预措施

Prehabilitation group

Experimental

Tele-supervised prehabilitation

干预措施: Prehabilitation (Behavioral)

Control group

No Intervention

Usual care

结局指标

主要结局

Change in cardiorespiratory fitness

时间窗: Assessments at baseline, one day before the surgery and 8 weeks after the surgery

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 and 8 weeks after the surgery)
  • Change in muscle endurance(Assessments at baseline, one day before the surgery and 8 weeks after the surgery)
  • Change in quality of life(Assessments at baseline, one day before the surgery and 8 weeks after the surgery)
  • Change in fatigue(Assessments at baseline, one day before the surgery and 8 weeks after the surgery)
  • Change in level of physical activity(Assessments at baseline, one day before the surgery and 8 weeks after the surgery)
  • Change in weight(Assessments at baseline, one day before the surgery and 8 weeks after the surgery)
  • Change in lean body mass(Assessments at baseline, one day before the surgery and 8 weeks after the surgery)
  • Change in fat body mass(Assessments at baseline, one day before the surgery and 8 weeks after the surgery)
  • Energy expenditure(During 7 days before the surgery and during 7 days after the surgery)
  • Change in Fasting glucose(Assessments at baseline, one day before the surgery and 8 weeks after the surgery)
  • Change in Fasting insulin(Assessments at baseline, one day before the surgery and 8 weeks after the surgery)
  • Change in cholesterol(Assessments at baseline, one day before the surgery and 8 weeks after the surgery)
  • Change in neutrophil/lymphocyte(Assessments at baseline, one day before the surgery and 8 weeks after the surgery)
  • Change in C-reactive protein(Assessments at baseline, one day before the surgery and 8 weeks after the surgery)
  • Adherence(Weekly through the intervention (during four weeks))
  • Change in executive functions(Assessments at baseline, one day before the surgery and 8 weeks after the surgery)

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Principal Investigator
主要研究者

Caty Gilles

Principal Investigator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

研究点 (2)

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