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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cystic Fibrosis, Covid19, Social Isolation

Intervention / Treatment
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* Other: Telerehabilitation-based
* Other: Follow-up based


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telerehabilitation<br>Telerehabilitation based exercise training will be given to the study group. | Other: Telerehabilitation-based<br>* 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.<br>|
| Experimental: Exercise brochure<br>Exercise training will be provided by sending a document to the control group | Other: Follow-up based<br>* 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. .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 minute sit to stand test (STS) repetitions | number of sit to stand for one minute is recorded | before exercise training | 
| 1 minute sit to stand test (STS) repetitions | number of sit to stand for one minute is recorded | one month | 
| 1 minute sit to stand test (STS) repetitions | number of sit to stand for one minute is recorded | six week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| crunch repetitions | number of crunch completed is recorded | before exercise training | 
| crunch repetitions | number of crunch completed is recorded | one month | 
| crunch repetitions | number of crunch completed is recorded | six week | 
| squat repetitions | number of squats completed is recorded | before exercise training | 
| squat repetitions | number of squats completed is recorded | one month | 
| squat repetitions | number of squats completed is recorded | six week | 
| push-up repetitions | number of push-ups completed is recorded | before exercise training | 
| push-up repetitions | number of push-ups completed is recorded | one month | 
| push-up repetitions | number of push-ups completed is recorded | six week | 
| plank duration | duration of keeping plank position is recorded | before exercise training | 
| plank duration | duration of keeping plank position is recorded | one month | 
| plank duration | duration of keeping plank position is recorded | six week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, sleep, cystic fibrosis