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临床试验/NCT02785861
NCT02785861已完成不适用

Evaluating the Effectiveness of Supervised Practice or Distance Supervised Physical Activity (Walking) in the Overall Management of Fatigue in Breast Cancer Patients During Hormonal Therapy: Pilot Study

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2013年2月18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
入组人数
17
试验地点
1
主要终点
fatigue of the patient with QLQC-30

研究概览

简要总结

After treatment, women want to regain a 'normal' lifestyle while some factors interfere as chronic fatigue. In the absence of anemia, fatigue is often a consequence of physical deconditioning . The following protocol will focus at this problem.It will consist of a brisk walking program twice a week over a period of 6 weeks, at an intensity of 60% of HR pic during 20 minutes.

详细描述

Pinto and colleagues, for a walking level from 55 to 65% HRmax, estimated a reduction of fatigue in post treatment. Supervised exercise show greater adherence to short-term practice at home. However, there are a growing number of studies suggesting a practice at home, the most activity being walking. The authors do not justify the choice of the type of supervision. But physical activity with a professional and / or group in a specific place definitely has different effects in relation to practice at home. Segal and his colleagues in 2001 for the first time wished to compare the two types of supervision. The results are in favor of supervised exercise. The training was identical. However, to answer the five weekly sessions requested, the patient group had to complete two supervised practice sessions at home. So, the investigators really can not quantify the difference in impact between home practice and supervised practice. In a meta-analysis, Velthuis and colleagues conclude a significant difference in fatigue during treatment for a supervised aerobic exercise against a home that does not show significant difference. If the training is the same in both situations, the investigators should not find any difference in physiologic responses. However, the psychological impact can vary from one situation to another.

The following protocol will focus at this problem. It will consist of a brisk walking program twice a week over a period of 6 weeks, at an intensity of 60% of HR pic during 20 minutes.

Biweekly session from 60% of the heart rate pic during 20 minutes will be proposed.

Each patient of supervised walking group will meet the student each session. Each patient of home-based walking group will be called by phone every week by the student to inform the patient of the progress of the training, collect the work and answer any questions.

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 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Sex: female
  • Age less than or equal to 75 years
  • Breast cancer stage I to III
  • Chemotherapy and / or radiotherapy adjuvant completed
  • Hormone treatments ongoing

排除标准

  • Age over 75 years
  • Breast cancer stage IV and O
  • Anemia, Cardiac arrhythmia, asthma, hypertension or uncontrolled diabetes, coronary artery disease or severe respiratory disease, psycho-cognitive may disturb walking program

研究组 & 干预措施

supervised practice

Experimental

brisk walking program twice a week over a period of 6 weeks, at an intensity of 60% of HR pic during 20 minutes.

Biweekly session from 60% of the heart rate pic during 20 minutes will be proposed.

Each patient of supervised walking group will meet the student each session

干预措施: supervision of physical activity (Behavioral)

distance supervised physical activity

Experimental

brisk walking program twice a week over a period of 6 weeks, at an intensity of 60% of HR pic during 20 minutes.

Biweekly session from 60% of the heart rate pic during 20 minutes will be proposed.

Each patient of home-based walking group will be called by phone every week by the student to inform the patient of the progress of the training, collect the work and answer any questions

干预措施: distance supervised physical activity (Behavioral)

结局指标

主要结局

fatigue of the patient with QLQC-30

时间窗: 6 weeks

次要结局

  • Activity level with IPAQ(6 weeks)
  • Global Quality of life with QLQC-30(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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