跳至主要内容
临床试验/NCT05723471
NCT05723471招募中不适用

Impact of a Collaborative Program of Customized, Adaptive and Supervised Physical Activity on Adherence, Fitness, Quality of Life and Resilience of Newly-diagnosed Cancer Patients

University Hospital, Toulouse4 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2024年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
350
试验地点
4
主要终点
Number of physical activity session

研究概览

简要总结

During the last twenty years, the cancer overall incidence has been increasing in europe and developed countries, while diagnostic and therapeutic progress have contributes to a reduction in mortality. Currently, almost 4 million people are treated or followed for cancer in France. The physical, psychological and social after-effects are significant.

Adaptated physical activity plays an important role in the rehabilitation process. Overall, meta-analyses carried-out with most frequent cancers demonstrate that physical activity practiced would allow an improvement in quality of life, tolerance to anticancer treatments and survival.

详细描述

This is a multicenter, two-arm parallel-group randomizes (in a 1:1 ratio), open-label, controlled intervention clinical trial of the comparison of long term adherence to physical activity between an adaptative, customized and collaborative exercise program and standard exercise prescription in patients with newly diagnosed cancer.

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
None

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

  • newly-diagnosed cancer patient
  • able to start a program of physical activity within the first year follow diagnosis
  • performance status between 0 to 2

排除标准

  • uncontrolled cardiovascular disease
  • peripheral neuropathy grade 3-4 with risk of falling
  • bone metastasis with risk of bone fracture
  • platelets <100X109/L
  • hemoglobin <8g/dL
  • patient under legal protection

结局指标

主要结局

Number of physical activity session

时间窗: 2 years

improvement of long-term adhesion to physical activity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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