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临床试验/NCT04742049
NCT04742049已完成不适用

The Effects of Telerehabilitation on Peripheral Muscle Function, Physical Activity Level and Sleep Quality in Pediatric Cystic Fibrosis Patients Having Social Isolation Due to Pandemic

Hacettepe University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年12月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
1 minute sit to stand test (STS) repetitions

研究概览

简要总结

The aim of this study is to evaluate the peripheral muscle function, sleep disorders and physical activity level in children with cystic fibrosis who are physically inactive at home due to social isolation and to examine the effect of the 6-week online exercise protocol.

详细描述

Considering the new coronavirus (COVID-19) pandemic global information, some patient populations have been identified at higher risk of this pandemic like older age, hypertension, cardiovascular and respiratory diseases. Self- isolation is recommended for preventive strategy in cystic fibrosis patients. Long-term social isolation and school closure can have negative effects on childrens' physical and mental health. Due to social isolation childrens are less physical active, have longer screen exposure and irregular sleep patterns.

There is no study to evaluate the the peripheral muscle function, sleep disorders and physical activity level and examine the effects of exercise training in children with cystic fibrosis in social isolation due the COVID-19 pandemic.

This study will be included children with cystic fibrosis who had stabile conditions Patients' peripheral muscle function, sleep quality and physical activity level will be assess and record at beginning, after the twelve and eighteen session.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • People who diagnosed cystic fibrosis disease at stabile conditions.
  • Volunteering to participate in the study,
  • Having a social isolation due to COVID-19 pandemic
  • Having forced expiratory volume at one second (FEV1) %> 40 % at last pulmonary function test.

排除标准

  • Being diagnosed with acute pulmonary exacerbation at the time of study and / or within the last month.
  • having a diagnosed with COVID-19 before or during the study
  • Being physically or perceptually competent to exercise
  • Patients with allergic bronchopulmonary aspergillosis (ABPA) who were treated with systemic steroid therapy
  • Patients who were not complete the exercise training ability.
  • Having FEV1 %< 40% at pulmonary function test.

结局指标

主要结局

1 minute sit to stand test (STS) repetitions

时间窗: six week

number of sit to stand for one minute is recorded

次要结局

  • sleep quality assessment(six week)
  • physical activity level(six week)
  • crunch repetitions(six week)
  • plank duration(six week)
  • squat repetitions(six week)
  • push-up repetitions(six week)

研究者

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

Kübra Kılıç

Physiotherapist

Hacettepe University

研究点 (1)

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