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

Sponsor
Hacettepe University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04742049
Collaborator
(none)
30
1
2
2.1
14.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Telerehabilitation-based
  • Other: Follow-up based
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 28, 2020
Anticipated Primary Completion Date :
Mar 1, 2021
Anticipated Study Completion Date :
Mar 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Telerehabilitation

Telerehabilitation based exercise training will be given to the study group.

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.

Experimental: Exercise brochure

Exercise training will be provided by sending a document to the control group

Other: 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. .

Outcome Measures

Primary Outcome Measures

  1. 1 minute sit to stand test (STS) repetitions [before exercise training]

    number of sit to stand for one minute is recorded

  2. 1 minute sit to stand test (STS) repetitions [one month]

    number of sit to stand for one minute is recorded

  3. 1 minute sit to stand test (STS) repetitions [six week]

    number of sit to stand for one minute is recorded

  4. crunch repetitions [before exercise training]

    number of crunch completed is recorded

  5. crunch repetitions [one month]

    number of crunch completed is recorded

  6. crunch repetitions [six week]

    number of crunch completed is recorded

  7. squat repetitions [before exercise training]

    number of squats completed is recorded

  8. squat repetitions [one month]

    number of squats completed is recorded

  9. squat repetitions [six week]

    number of squats completed is recorded

  10. push-up repetitions [before exercise training]

    number of push-ups completed is recorded

  11. push-up repetitions [one month]

    number of push-ups completed is recorded

  12. push-up repetitions [six week]

    number of push-ups completed is recorded

  13. plank duration [before exercise training]

    duration of keeping plank position is recorded

  14. plank duration [one month]

    duration of keeping plank position is recorded

  15. plank duration [six week]

    duration of keeping plank position is recorded

Secondary Outcome Measures

  1. sleep quality assessment [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 14 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hacettepe University Ankara Turkey

Sponsors and Collaborators

  • Hacettepe University

Investigators

  • Principal Investigator: Deniz Dogru-Ersoz, Professor, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kübra Kılıç, Physiotherapist, Hacettepe University
ClinicalTrials.gov Identifier:
NCT04742049
Other Study ID Numbers:
  • KA-20058
First Posted:
Feb 5, 2021
Last Update Posted:
Feb 5, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kübra Kılıç, Physiotherapist, Hacettepe University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 5, 2021