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临床试验/NCT03162484
NCT03162484已完成不适用

Effect of a Physical Activity Group Programme on the Health of People With Chronic Acquired Brain Injury

Universidad Politecnica de Madrid0 个研究点目标入组 60 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Mood change measurement

研究概览

简要总结

Most individuals who have survived an acquired brain injury (ABI) present consequences affecting the sensorimotor, cognitive, affective or behavioural components. The conditions can vary from mild to extreme. The consequences of an ABI may have a considerable impact on their functioning, and secondary conditions like depression or sedentary behaviours, so they suffer changes in their Health-Related Quality of Life (HRQoL).

The purpose of this project is to determine the effect of a physical activity group program on HRQoL. As well as to identify factors that facilitate or act as a barrier to practice physical activity.

详细描述

This study is a quasi experimental pre-post test with nonequivalent group design. There were two groups: 30 subjects with chronic ABI took part in a physical activity group program designed by a Sport Club in Madrid, Spain; and 30 subjects with chronic ABI which did not practice physical activity.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • Individuals with mild to moderate chronic acquired brain injury from any cause.
  • Being over 18 years of age.
  • Being practice two or more sessions per week.
  • Ability to understand and complete questionnaires in Spanish.
  • Voluntary participation in the study.
  • Signed informed consent by the patient and/or their primary caregiver.

排除标准

  • Return to work

结局指标

主要结局

Mood change measurement

时间窗: Change from baseline mood at 18 weeks

Profile of Mood States (POMS) Questionnaire

Quality of life change measurement

时间窗: Change from baseline quality of life at 18 weeks

Short Form 36 Health Survey

Participation in Physical Activities change measurement

时间窗: Change from baseline participation at 18 weeks

Global Physical Activity Questionnaire

次要结局

  • Months since injury(Baseline)
  • Depression change measurement(Change from baseline depression at 18 weeks)
  • Amount of weekly physical activity(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marta Pérez Rodriguez

Principal investigator

Universidad Politecnica de Madrid

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