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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04742049
• Other study ID #: KA-20058
• Status: Completed
• Phase: N/A
• Start date: December 28, 2020
• Est. completion date: March 29, 2021

Study information

• Verified date: August 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 29, 2021
• Est. primary completion date: March 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Cystic Fibrosis
• Fibrosis
• Social Isolation

Intervention

Other:
• Telerehabilitation-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. 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.
• Follow-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. .

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 minute sit to stand test (STS) repetitions	number of sit to stand for one minute is recorded	before exercise training
Primary	1 minute sit to stand test (STS) repetitions	number of sit to stand for one minute is recorded	one month
Primary	1 minute sit to stand test (STS) repetitions	number of sit to stand for one minute is recorded	six week
Secondary	sleep quality assessment	Sleep 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.	before exercise training
Secondary	sleep quality assessment	Sleep 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.	six week
Secondary	physical activity level	Physical 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.	before exercise training
Secondary	physical activity level	Physical 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.	six week
Secondary	crunch repetitions	number of crunch completed is recorded	before exercise training
Secondary	crunch repetitions	number of crunch completed is recorded	one month
Secondary	crunch repetitions	number of crunch completed is recorded	six week
Secondary	squat repetitions	number of squats completed is recorded	before exercise training
Secondary	squat repetitions	number of squats completed is recorded	one month
Secondary	squat repetitions	number of squats completed is recorded	six week
Secondary	push-up repetitions	number of push-ups completed is recorded	before exercise training
Secondary	push-up repetitions	number of push-ups completed is recorded	one month
Secondary	push-up repetitions	number of push-ups completed is recorded	six week
Secondary	plank duration	duration of keeping plank position is recorded	before exercise training
Secondary	plank duration	duration of keeping plank position is recorded	one month
Secondary	plank duration	duration of keeping plank position is recorded	six week