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临床试验/NCT06097624
NCT06097624已完成不适用

Effectiveness of Synchronized Tele-exercise on Sleep Quality and Quality of Life for Healthy Young Adults: A Randomized Double-blind Controlled Trial

Okan University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
World Health Organization Quality of Life-Brief Form

研究概览

简要总结

The aim of this study is to determine the effect of telehealth-synchronized group exercise on sleep and quality of life, and secondarily, on the health and body perception of healthy young adults. This study is planned as a randomized double-blind controlled clinical study.

详细描述

The aim of this study is to determine the effect of telehealth-synchronized group exercise on sleep and quality of life, and secondarily, on the health and body perception of healthy young adults. This study is planned as a randomized double-blind controlled clinical study. The sample size was calculated using G*power 3.1.9.2, which required 42 patients and a size effect of 0.8, 80% power, 1:1 allocation ratio, and an error probability of 0.05. Forty-eight participants were planned to be included in the study, based on the probability that 15% of the patients could be excluded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

盲法说明

Examiners and researchers who are going to run the data analysis will be blinded to the assignment

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • being a volunteer,
  • being in the age range of 18-25,
  • having no barriers to online sessions through a computer,
  • having no visual impairment.

排除标准

  • having experienced a physical injury in the last 3 months
  • having any major disorder,
  • learning difficulty,
  • having a mental disorder that could affect the results

结局指标

主要结局

World Health Organization Quality of Life-Brief Form

时间窗: 4th week

The WHOQOL is based on a purely subjective evaluation to assess the perceived quality of life. The short version, the World Health Organization Quality of Life-Brief Form (WHOQOL-BREF) is a 26-item self-report questionnaire that assesses the quality of life (QOL) within the context of an individual's culture, value systems, personal goals, standards, and concerns. It covers four domains: physical health, psychological health, social relationships, and environmental health.

The Pittsburgh Sleep Quality Index (PSQI)

时间窗: 4th week

The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire that assesses sleep quality over the last month. Its adaptation to Turkish and its reliability and validity analyses were carried out in 1996 by Ağargün el al. It covers seven components of sleep each of which are scored between 0-3: sleep duration, sleep disturbances, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use. The PSQI provides a global score that ranges from 0 to 21, with higher scores indicating poorer sleep quality: smaller than 5, the score points to "Good Sleep Quality"; greater than or equal to 5, it indicates poor sleep quality (Buysee 1989, Agargun 1996). PSQI is a reliable and valid tool for assessing sleep quality in clinical and research settings.

次要结局

  • Body Perception(4th week)
  • Perception of Physical Fitness(4th week)
  • Perception of General Health(4th week)

研究者

发起方
Okan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Begüm Okudan

Researcher

Okan University

研究点 (1)

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