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The Effects of Telerehabilitation on Muscle Function, Physical Activity and Sleep in Cystic Fibrosis During Pandemic

H

Hacettepe University

Status

Completed

Conditions

Covid19
Cystic Fibrosis
Social Isolation

Treatments

Other: Telerehabilitation-based
Other: Follow-up based

Study type

Interventional

Funder types

Other

Identifiers

NCT04742049
KA-20058

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 patients

Sex

All

Ages

8 to 14 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Telerehabilitation
Experimental group
Description:
Telerehabilitation based exercise training will be given to the study group.
Treatment:
Other: Telerehabilitation-based
Exercise brochure
Experimental group
Description:
Exercise training will be provided by sending a document to the control group
Treatment:
Other: Follow-up based

Trial contacts and locations

1

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Central trial contact

Kubra Kilic, PhD Student; Hacettepe University

Data sourced from clinicaltrials.gov

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