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Completed

NCT Number: NCT04742049

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

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.

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Key information

Conditions

Cystic Fibrosis Behavior COVID-19 Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronaviridae Infections Coronavirus Infections Covid19 Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Infections Lung Diseases Motor Activity Nidovirales Infections Pancreatic Diseases Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Social Behavior Social Isolation Virus Diseases

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telerehabilitation-based

Other

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

Other

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. .

Primary outcomes

  1. 1 minute sit to stand test (STS) repetitions

    Time frame: before exercise training

    number of sit to stand for one minute is recorded

  2. 1 minute sit to stand test (STS) repetitions

    Time frame: one month

    number of sit to stand for one minute is recorded

  3. 1 minute sit to stand test (STS) repetitions

    Time frame: six week

    number of sit to stand for one minute is recorded

Secondary outcomes

  1. sleep quality assessment

    Time frame: before exercise training

    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.

  2. sleep quality assessment

    Time frame: six week

    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.

  3. physical activity level

    Time frame: before exercise training

    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.

  4. physical activity level

    Time frame: six week

    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.

  5. crunch repetitions

    Time frame: before exercise training

    number of crunch completed is recorded

  6. crunch repetitions

    Time frame: one month

    number of crunch completed is recorded

  7. crunch repetitions

    Time frame: six week

    number of crunch completed is recorded

  8. squat repetitions

    Time frame: before exercise training

    number of squats completed is recorded

  9. squat repetitions

    Time frame: one month

    number of squats completed is recorded

  10. squat repetitions

    Time frame: six week

    number of squats completed is recorded

  11. push-up repetitions

    Time frame: before exercise training

    number of push-ups completed is recorded

  12. push-up repetitions

    Time frame: one month

    number of push-ups completed is recorded

  13. push-up repetitions

    Time frame: six week

    number of push-ups completed is recorded

  14. plank duration

    Time frame: before exercise training

    duration of keeping plank position is recorded

  15. plank duration

    Time frame: one month

    duration of keeping plank position is recorded

  16. plank duration

    Time frame: six week

    duration of keeping plank position is recorded

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2021
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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