跳至主要内容
临床试验/NCT04581005
NCT04581005Unknown不适用

Prehabilitation to Enhance Functional Capacity in Esophageal Cancer Care

McGill University Health Centre/Research Institute of the McGill University Health Centre2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2019年8月19日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
54
试验地点
2
主要终点
Oxygen consumption (VO2)

研究概览

简要总结

Prehabilitation utilizes the preoperative period to prevent or attenuate the treatment-related functional decline and its consequences. This project aims at testing feasibility and effectiveness of multimodal prehabilitation in esophageal cancer care.

详细描述

While evidence on prehabilitation is mounting, upper gastrointestinal surgery still remains under-investigated. This trial aims to explore the effect of prehabilitation over the whole perioperative trajectory, including neo-adjuvant treatment (NAT).

Multimodal prehabilitation includes exercise, nutrition therapy, and mental distress coping strategies. In the context of a multimodal approach, the two groups follow different exercise prescriptions: high-intensity interval supervised training prescribed accordingly cardiopulmonary exercise testing (CPET)-derived variables, versus a home-based program. For both groups, multimodal prehabilitation is prescribed over the whole preoperative period, including during NAT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (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

入选标准

  • Patients with non-metastatic esophageal cancer undergoing neo-adjuvant chemotherapy and surgery.

排除标准

  • co-morbid medical, physical and mental conditions that contraindicate exercise or oral nutrition

结局指标

主要结局

Oxygen consumption (VO2)

时间窗: Change from baseline to post neo-adjuvant therapy (average duration 6-8 weeks)

Oxygen consumption at anaerobic threshold (VO2 at AT) measured with cardiopulmonary exercise testing (CPET)

次要结局

未报告次要终点

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

Professor

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

研究点 (2)

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