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

Primary Purpose

Cystic Fibrosis, Covid19, Social Isolation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation-based
Follow-up based
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring exercise, sleep, cystic fibrosis

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Telerehabilitation

Exercise brochure

Arm Description

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

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

Outcomes

Primary Outcome Measures

1 minute sit to stand test (STS) repetitions
number of sit to stand for one minute is recorded
1 minute sit to stand test (STS) repetitions
number of sit to stand for one minute is recorded
1 minute sit to stand test (STS) repetitions
number of sit to stand for one minute is recorded

Secondary Outcome Measures

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.
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.
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.
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.
crunch repetitions
number of crunch completed is recorded
crunch repetitions
number of crunch completed is recorded
crunch repetitions
number of crunch completed is recorded
squat repetitions
number of squats completed is recorded
squat repetitions
number of squats completed is recorded
squat repetitions
number of squats completed is recorded
push-up repetitions
number of push-ups completed is recorded
push-up repetitions
number of push-ups completed is recorded
push-up repetitions
number of push-ups completed is recorded
plank duration
duration of keeping plank position is recorded
plank duration
duration of keeping plank position is recorded
plank duration
duration of keeping plank position is recorded

Full Information

First Posted
January 17, 2021
Last Updated
August 8, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04742049
Brief Title
The Effects of Telerehabilitation on Muscle Function, Physical Activity and Sleep in Cystic Fibrosis During Pandemic
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 28, 2020 (Actual)
Primary Completion Date
March 29, 2021 (Actual)
Study Completion Date
March 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Covid19, Social Isolation
Keywords
exercise, sleep, cystic fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation
Arm Type
Experimental
Arm Description
Telerehabilitation based exercise training will be given to the study group.
Arm Title
Exercise brochure
Arm Type
Experimental
Arm Description
Exercise training will be provided by sending a document to the control group
Intervention Type
Other
Intervention Name(s)
Telerehabilitation-based
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Follow-up based
Intervention Description
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 Outcome Measure Information:
Title
1 minute sit to stand test (STS) repetitions
Description
number of sit to stand for one minute is recorded
Time Frame
before exercise training
Title
1 minute sit to stand test (STS) repetitions
Description
number of sit to stand for one minute is recorded
Time Frame
one month
Title
1 minute sit to stand test (STS) repetitions
Description
number of sit to stand for one minute is recorded
Time Frame
six week
Secondary Outcome Measure Information:
Title
sleep quality assessment
Description
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.
Time Frame
before exercise training
Title
sleep quality assessment
Description
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.
Time Frame
six week
Title
physical activity level
Description
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.
Time Frame
before exercise training
Title
physical activity level
Description
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.
Time Frame
six week
Title
crunch repetitions
Description
number of crunch completed is recorded
Time Frame
before exercise training
Title
crunch repetitions
Description
number of crunch completed is recorded
Time Frame
one month
Title
crunch repetitions
Description
number of crunch completed is recorded
Time Frame
six week
Title
squat repetitions
Description
number of squats completed is recorded
Time Frame
before exercise training
Title
squat repetitions
Description
number of squats completed is recorded
Time Frame
one month
Title
squat repetitions
Description
number of squats completed is recorded
Time Frame
six week
Title
push-up repetitions
Description
number of push-ups completed is recorded
Time Frame
before exercise training
Title
push-up repetitions
Description
number of push-ups completed is recorded
Time Frame
one month
Title
push-up repetitions
Description
number of push-ups completed is recorded
Time Frame
six week
Title
plank duration
Description
duration of keeping plank position is recorded
Time Frame
before exercise training
Title
plank duration
Description
duration of keeping plank position is recorded
Time Frame
one month
Title
plank duration
Description
duration of keeping plank position is recorded
Time Frame
six week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniz Dogru-Ersoz, Professor
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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