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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04742049
Enrollment
30
Registered
2021-02-05
Start date
2020-12-28
Completion date
2021-03-29
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Cystic Fibrosis, Social Isolation

Keywords

exercise, sleep, cystic fibrosis

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.

Interventions

15 pediatric cystic fibrosis patients who are at home during the self- isolation process due to the COVID-19 pandemic will be included in this group. Online exercise training protocol will be apply for patients. Each training protocol was planned as 30 minutes for 3 days a week for 6 weeks with a physiotherapist. Exercise protocol will start with the warm-up exercises and finish with cooling exercises.

OTHERFollow-up based

15 pediatric cystic fibrosis patients who are at home during the self- isolation process due to the COVID-19 pandemic will be included in this group. An exercise document including the same exercise protocol in study group will be sent the patients. Patients will be called by the physiotherapist once a week for follow-up. .

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
1 minute sit to stand test (STS) repetitionsbefore exercise trainingnumber of sit to stand for one minute is recorded

Secondary

MeasureTime frameDescription
physical activity levelbefore exercise trainingPhysical activity level will be evaluated by Physical Activity Questionnaire. Physical Activity Questionnaire is composed ten questions that evaluate the physical activity status for the last seven days. Each question, except last question is evaluated on a 5-point scale and there is an activity score between 1-5. 1 indicates low physical activity, 5 indicates high physical activity.
crunch repetitionsbefore exercise trainingnumber of crunch completed is recorded
sleep quality assessmentbefore exercise trainingSleep quality will be evaluated by Epworth Sleepiness Scale and Pediatric Sleep Questionnaire (PSQ). Epworth Sleepiness Scale evaluates persons' daytime sleepiness and scores ranged from 0-24. Higher scores indicate higher daytime sleepiness. PSQ consist of 22 items that evaluate the frequency and severity of snoring during sleep, apnea at night during sleep hyperactivity and other pediatric obstructive sleep apnea symptoms. Responses to the items are as yes, no and I don't know which are scored as 1, 0 and missing respectively. Total score of PSQ is the mean of the scores of all items excluding the missing items.
push-up repetitionsbefore exercise trainingnumber of push-ups completed is recorded
plank durationbefore exercise trainingduration of keeping plank position is recorded
squat repetitionsbefore exercise trainingnumber of squats completed is recorded

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026