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临床试验/NCT03361150
NCT03361150已完成不适用

High-Intensity Interval Training Versus Moderate Continuous Training in Multimodal Prehabilitation for Colorectal Surgery: A Randomized Controlled Trial.

McGill University Health Centre/Research Institute of the McGill University Health Centre1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Oxygen consumption (VO2)

研究概览

简要总结

Surgery is a stressful procedure associate with perioperative physical impairment. In a previous study, the investigators showed that physical fitness could be optimize in surgical patients using prehabilitation, a preoperative conditioning intervention in form of exercise, nutrition and relaxation technique. The best modality of exercise has yet to be known.The purpose of this study is to compare high interval (HIT) vs. moderate continuous intensity (MC) training, integrated in a prehabilitation intervention in colorectal surgical patients.

详细描述

All patients will receive prehabilitation preoperatively for 4 weeks, that is composed of 3 elements, exercise, nutritional supplements and psychological coping strategies. Both exercise protocol will be supervised, 3-time per week, in-hospital programs. Patients will be randomized to perform either HIT or MC training. Exercise intensity will be defined and personalized on the individual values at cardiopulmonary exercise testing (CPET). Patients' nutritional status and dietary intake will be assessed by the nutritionist, and supplement will be prescribed if needed to achieve a daily intake of 1.5 g protein/kg. Perioperative care will follow the McGill Surgical Recovery Pathway, also called Enhanced Recovery Program, which is an evidence-based care plan set up by the Surgical Recovery (SuRe) multidisciplinary committee of the McGill University Health Centre.

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
Double (Investigator, Outcomes Assessor)

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

  • •Subjects eligible to enter the study will include those aged 18 and above and referred electively for resection of malignant colorectal lesions.

排除标准

  • •American Society of Anesthesiologists (ASA) health status class 4-5 or co-morbid medical, physical and mental conditions interfering with the ability to perform exercise at home or to complete the testing procedures. Poor English and French comprehension.

研究组 & 干预措施

HIT

Experimental

Preoperative nutrition, relaxation strategies + high intensity interval training (HIT). HIT alternates a series of high-intensity bouts with relief period. This will be a personalized, 3 times per week, 40-min exercise. Protein supplement will be prescribed if needed to achieve a daily intake of 1.5 g protein/kg.

干预措施: HIT (Procedure)

MCT

Active Comparator

Preoperative nutrition, relaxation strategies + high intensity interval training (MCT). MCT is continuous exercise with a constant intensity below anaerobic threshold. This will be a personalized, 3 times per week, 40-min exercise. Protein supplement will be prescribed if needed to achieve a daily intake of 1.5 g protein/kg.

干预措施: MCT (Procedure)

结局指标

主要结局

Oxygen consumption (VO2)

时间窗: 4 weeks (before surgery)

Cardiopulmonary exercise testing (CPET) will be conducted on a cycle ergometer. Coupling expired gas analysis with minute ventilation, It will provide oxygen consumption during exercise.

次要结局

  • Sit-to-Stand test(4 weeks (before surgery))
  • Six-minute walking distance.(4 weeks (before surgery))
  • Community Health Activities Model Program for Seniors (CHAMPS) score(4 weeks (before surgery))
  • Hospital Anxiety and Depression Scale (HADS) score(4 weeks (before surgery))

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Franco Carli

Clinical Professor

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (1)

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