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临床试验/NCT00661843
NCT00661843已完成不适用

A Mixed Design, With Wait List Control Crossover to Intervention, Clinical Trial of Integrated Yoga Style Practice Intervention for Improving Sleep and Quality of Life in the Elderly Population

Shaare Zedek Medical Center2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2008年5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
74
试验地点
2
主要终点
Subjective sleep and life quality assessment using standard questionnaires and sleep logs

研究概览

简要总结

Insomnia is common in the elderly population and is associated with increased health problems, reduced quality of life and greater use of sleep inducing drugs. This research aims to examine the effectiveness of Yoga practice to treat insomnia in elderly people, determine the ability to enhance their quality of life and determine if it is suitable to western culture and conditions.

详细描述

Introduction: Geriatric insomnia is prevalent, reducing life quality, diminishing cognition and increasing risk of accidents and mortality. Treatment with sedative-hypnotic drugs has limited effectiveness and further increases the risk of accidents and falls. Yoga has been shown to increase well-being in the elderly.

Hypotheses

  1. Integrated yoga style practice can improve sleep quality/quantity
  2. Integrated yoga style practice can improve quality of life.

Objectives:

  1. Examine effectiveness of yoga for insomnia and reduction in use of hypnotics/relaxants in the elderly;
  2. Determine whether yoga enhances quality of life in the elderly; and 3. Determine whether yoga is suitable for elderly in western culture(s).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 60 years or older
  • Independent, self mobile
  • Suffering from light to severe primary insomnia

排除标准

  • Age less than 60 years
  • Currently or in the past engaged in regular yoga practice
  • Suffering from any physical or mental health condition or disability which may affect sleep, or for which Yoga practice is counter indicated or may lead to health risks or complications.
  • Suffering from co-morbid insomnia in conjunction with another condition clearly salient to sleep disturbance.

结局指标

主要结局

Subjective sleep and life quality assessment using standard questionnaires and sleep logs

时间窗: 24 weeks

all measures taken at baseline and post intervention for all participants participant who crossed over measured pre and post control phase and post intervention phase

Objective home based sleep studies using

时间窗: 24 weeks

objective sleep studies using embletta mobile sleep recording system in conjunction with the HPC1000 sleep analysis system. all measures taken pre and post intervention. Participants who crossed over measured pre control, post control and post intervention phases

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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