Cystic FibrosisNCT04742049
The Effects of Telerehabilitation on Muscle Function, Physical Activity and Sleep in Cystic Fibrosis During Pandemic
A study testing Telerehabilitation-based and Follow-up based in people with Cystic Fibrosis and Covid19, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Cystic Fibrosis, Covid19, Social Isolation
- What is being tested?
- Telerehabilitation-based and Follow-up based
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Dec 2020to 29 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cystic Fibrosis, Covid19, Social Isolation
- Being tested
- Telerehabilitation-based, Follow-up based
- Keywords
- exercise, sleep, cystic fibrosis
- Medical subject headings
- Cystic Fibrosis, COVID-19, Social Isolation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation-basedOther
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 basedOther
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. .
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | Telerehabilitation based exercise training will be given to the study group. Receives: Other: Telerehabilitation-based |
| Exercise brochure | Experimental | Exercise training will be provided by sending a document to the control group Receives: Other: Follow-up based |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 minute sit to stand test (STS) repetitions
number of sit to stand for one minute is recorded
Measured: before exercise training
1 minute sit to stand test (STS) repetitions
number of sit to stand for one minute is recorded
Measured: one month
1 minute sit to stand test (STS) repetitions
number of sit to stand for one minute is recorded
Measured: six week
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: six week
crunch repetitions
number of crunch completed is recorded
Measured: before exercise training
crunch repetitions
number of crunch completed is recorded
Measured: one month
crunch repetitions
number of crunch completed is recorded
Measured: six week
squat repetitions
number of squats completed is recorded
Measured: before exercise training
squat repetitions
number of squats completed is recorded
Measured: one month
squat repetitions
number of squats completed is recorded
Measured: six week
push-up repetitions
number of push-ups completed is recorded
Measured: before exercise training
push-up repetitions
number of push-ups completed is recorded
Measured: one month
push-up repetitions
number of push-ups completed is recorded
Measured: six week
plank duration
duration of keeping plank position is recorded
Measured: before exercise training
plank duration
duration of keeping plank position is recorded
Measured: one month
plank duration
duration of keeping plank position is recorded
Measured: six week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start28 Dec 2020
- Primary completion29 Mar 2021
- Study completion29 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Kılıç, Hacettepe University
- Investigators
- Deniz Dogru-Ersoz, Professor, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742049
- Sponsor's protocol ID
- KA-20058
- Status last verified
- Aug 2023
- First submitted
- 17 Jan 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04742049
- Acronym / sponsor ID
- KA-20058
- Conditions
- Cystic Fibrosis, Covid19, Social Isolation
- Keywords
- exercise, sleep, cystic fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- 29 Mar 2021 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Other: Telerehabilitation-basedTelerehabilitation based exercise training will be given to the study group. |
| Exercise brochure | Experimental | Other: Follow-up basedExercise training will be provided by sending a document to the control group |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation-based15 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. | Other | Telerehabilitation |
| Follow-up based15 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. . | Other | Exercise brochure |
Primary outcome
1 minute sit to stand test (STS) repetitions
Time frame: before exercise training
number of sit to stand for one minute is recorded
1 minute sit to stand test (STS) repetitions
Time frame: one month
number of sit to stand for one minute is recorded
1 minute sit to stand test (STS) repetitions
Time frame: six week
number of sit to stand for one minute is recorded
16 secondary outcomes
sleep quality assessment
Time frame: before exercise training
sleep quality assessment
Time frame: six week
physical activity level
Time frame: before exercise training
physical activity level
Time frame: six week
crunch repetitions
Time frame: before exercise training
crunch repetitions
Time frame: one month
crunch repetitions
Time frame: six week
squat repetitions
Time frame: before exercise training
squat repetitions
Time frame: one month
squat repetitions
Time frame: six week
push-up repetitions
Time frame: before exercise training
push-up repetitions
Time frame: one month
push-up repetitions
Time frame: six week
plank duration
Time frame: before exercise training
plank duration
Time frame: one month
plank duration
Time frame: six week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deniz Dogru-Ersoz, Professor principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation-based and Follow-up based in people with Cystic Fibrosis and Covid19, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 minute sit to stand test (STS) repetitions (time frame: before exercise training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.