Clinical trial NCT04742049: The Effects of Telerehabilitation on Muscle Function, Physical Activity and Sleep in Cystic Fibrosis During Pandemic
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Covid19
Social Isolation
Keywords: exercise
sleep
cystic fibrosis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 1 minute sit to stand test (STS) repetitions
timeFrame: before exercise training
measure: 1 minute sit to stand test (STS) repetitions
timeFrame: one month
measure: 1 minute sit to stand test (STS) repetitions
timeFrame: six week
Secondary outcomes:
measure: sleep quality assessment
timeFrame: before exercise training
measure: sleep quality assessment
timeFrame: six week
measure: physical activity level
timeFrame: before exercise training
measure: physical activity level
timeFrame: six week
measure: crunch repetitions
timeFrame: before exercise training
measure: crunch repetitions
timeFrame: one month
measure: crunch repetitions
timeFrame: six week
measure: squat repetitions
timeFrame: before exercise training
measure: squat repetitions
timeFrame: one month
measure: squat repetitions
timeFrame: six week
measure: push-up repetitions
timeFrame: before exercise training
measure: push-up repetitions
timeFrame: one month
measure: push-up repetitions
timeFrame: six week
measure: plank duration
timeFrame: before exercise training
measure: plank duration
timeFrame: one month
measure: plank duration
timeFrame: six week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Deniz Dogru-Ersoz, Professor
role: PRINCIPAL_INVESTIGATOR
References: