Cystic FibrosisNCT05481190
The Impact Of A Tele-Exercise Program For Children With Cystic Fibrosis During The Covid-19 Pandemic On Quality Of Life
A study testing Tele-Exercise Program and Just observation in people with Cystic Fibrosis and Exercise Addiction, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the effect of the tele-exercise program applied to children with cystic fibrosis in the Covid-19 pandemic on the quality of life and the symptoms experienced during exercise Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Cystic Fibrosis, Exercise Addiction, Nursing Caries
- What is being tested?
- Tele-Exercise Program and Just observation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 15 Feb 2022
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Voluntary to participate in the study
- Getting consent from parents
- Being a child with cystic fibrosis between the ages of 10-18
- Having no psychological health problems
- No physical problems that would prevent the child from exercising"
- Computer/ owning a smart phone and being able to use these devices and having an internet connection at home".
Who cannot join
- Not participating in the exercise regularly (at least 2 times)",
- Not wanting to continue working out".
- Not being willing to participate in the study
- Not being able to get consent from their parents
- Being under the age of 10, over the age of 18 with a diagnosis of Cystic Fibrosis
- Having a psychological health problem
Show all 9Show fewer
- Having a physical problem that prevents the child from exercising
- Using a computer/smartphone not having and not being able to use these devices
- Not having an internet connection at home".
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University
Samsun, Atakum, 55139
About this study
Official title: The Impact Of A Tele-Exercise Program For Children With Cystic Fibrosis During The Covid-19 Pandemic On Quality Of Life: A Randomized Controlled Trial
The aim of this study was to examine the effect of the tele-exercise program applied to children with cystic fibrosis in the Covid-19 pandemic on the quality of life and the symptoms experienced during exercise
Read the detailed description
Cystic fibrosis is a chronic, progressive, life-shortening, genetic, complex disease that affects multiple organs and systems. The care and treatment process of cystic fibrosis disease requires a multidisciplinary approach. Regular exercise (as it is an important component of therapeutic treatment) improves respiratory function in children with cystic fibrosis. However, the treatment burden of the disease in the child and the serious respiratory system complications caused by the Covid-19 infection during the pandemic process cause patients with cystic fibrosis to be in the high risk group. Since it is thought that it is difficult for children with cystic fibrosis to exercise during the pandemic process, home exercise programs have gained importance. With the developing technology, patients are consulted remotely, training and consultancy services are provided and they can be followed continuously through phone calls and video conferences. Nurses are an important part of the multidisciplinary team responsible for the protection, development and maintenance of the health of the individual in every period of life. They have assumed the roles of educator, consultant, decision-maker, therapeutic, caregiver and researcher in order to protect the quality of life of children with exercise programs and to ensure that they lead an active life. In order for nurses to make exercise a part of the lives of children with cystic fibrosis, they should determine the knowledge level, awareness and needs of children and their families, and provide adequate and effective counseling so that they can meet their individual needs.
- Being tested
- Tele-Exercise Program, Just observation
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-Exercise ProgramBehavioural
Data collection tools were applied to the tele-exercise group and control group at the beginning of the study. For the tele-exercise group, by the researcher, Exp. A 6-week exercise program was created under the consultancy of a physiotherapist. Children who met the research criteria were asked to do these exercises for 20 minutes, 3 times a week for 6 weeks. The exercises were performed online with the researcher at the scheduled time one day a week, and by the children twice a week. On the days they exercised, diaries consisting of semi-structured questions were sent to the children's addresses by cargo and they were allowed to keep a diary. Phone calls were made once a week to provide motivation and increase compliance with exercise. A smart watch was sent to the children by cargo to increase motivation. The children were asked to fill in the follow-up form, which was sent via weekly google forms.
Just observationBehavioural
Standard care was given to the children in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Tele-exercise program to Child with Cystic Fibrosis | Experimental | Inclusion criteria were "Voluntary to participate in the study", "Getting consent from parents", "Being a child with cystic fibrosis between the ages of 10-18", "Having no psychological health problems", "No physical problems that would prevent the child from exercising" and "Computer/ owning a smart phone and being able to use these devices", "Having an internet connection at home".
The exclusion criteria were "Not volunteering to participate in the study", "Not being able to get consent from their parents", "Being under the age of 10 or over the age of 18 with a diagnosis of Cystic Fibrosis", "Having a psychological health problem", "Having a physical problem that prevents the child from exercising" and "Not having a computer/smart phone and not being able to use these devices" and "Not having an internet connection at home".
Exclusion criteria are "Not participating in the exercise regularly (at least 2 times)", "Not wanting to continue working out". Receives: Behavioral: Tele-Exercise Program; Behavioral: Just observation |
| Without exercise Child with Cystic Fibrosis | Experimental | Inclusion criteria were "Voluntary to participate in the study", "Getting consent from parents", "Being a child with cystic fibrosis between the ages of 10-18", "Having no psychological health problems", "No physical problems that would prevent the child from exercising" and "Computer/ owning a smart phone and being able to use these devices", "Having an internet connection at home".
The exclusion criteria were "Not volunteering to participate in the study", "Not being able to get consent from their parents", "Being under the age of 10 or over the age of 18 with a diagnosis of Cystic Fibrosis", "Having a psychological health problem", "Having a physical problem that prevents the child from exercising" and "Not having a computer/smart phone and not being able to use these devices" and "Not having an internet connection at home".
Exclusion criteria are "Not participating in the exercise regularly (at least 2 times)", "Not wanting to continue working out". Receives: Behavioral: Tele-Exercise Program; Behavioral: Just observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
changing the quality of life
changing the quality of life of children with cystic fibrosis after tele-exercise program
Measured: Up to Six Weeks
affects the symptoms
affects the symptoms experienced by the children in the tele-exercise group during exercise.
Measured: Up to Six Weeks
Secondary outcomes (2)
changing the quality of life "Cystic Fibrosis Quality of Life Questionnaire"
The questionnaire prepared in a four-point likert type is scored according to frequency and difficulty level or whether the answers are correct or incorrect. It is thought that the higher the total score obtained from the questionnaire, the higher the health-related quality of life.
Measured: Up to Six Weeks
affects the symptoms during the tele-exercise
The children were asked to record their symptom findings daily and they were asked to share the recording documents with the researcher. In addition, the researcher questioned the symptom findings of the participants once a week by phone call and once a week via google form. The symptoms questioned through diary keeping, phone call and google form were recorded as symptom present/absent.
Measured: Up to Six Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Apr 2021
- Primary completion15 Sep 2021
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized controlled experimental study.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Koyun, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481190
- Sponsor's protocol ID
- Tele-Exercise
- Status last verified
- Dec 2023
- First submitted
- 28 Jul 2022
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: other researhers may view the study once it is published.
Publications
Chen JJ, Cooper DM, Haddad F, Sladkey A, Nussbaum E, Radom-Aizik S. Tele-Exercise as a Promising Tool to Promote Exercise in Children With Cystic Fibrosis. Front Public Health. 2018 Sep 28;6:269. doi: 10.3389/fpubh.2018.00269. eCollection 2018.
PubMed 30324099Cox NS, Alison JA, Button BM, Wilson JW, Holland AE. Feasibility and acceptability of an internet-based program to promote physical activity in adults with cystic fibrosis. Respir Care. 2015 Mar;60(3):422-9. doi: 10.4187/respcare.03165. Epub 2014 Nov 25.
PubMed 25425703Quittner AL, Buu A, Messer MA, Modi AC, Watrous M. Development and validation of The Cystic Fibrosis Questionnaire in the United States: a health-related quality-of-life measure for cystic fibrosis. Chest. 2005 Oct;128(4):2347-54. doi: 10.1378/chest.128.4.2347.
PubMed 16236893
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Of A Tele-Exercise Program For Children With Cystic Fibrosis During The Covid-19 Pandemic On Quality Of Life: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05481190
- Acronym / sponsor ID
- Tele-Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 1 Aug 2022 (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 was to examine the effect of the tele-exercise program applied to children with cystic fibrosis in the Covid-19 pandemic on the quality of life and the symptoms experienced during exercise
Detailed description
Cystic fibrosis is a chronic, progressive, life-shortening, genetic, complex disease that affects multiple organs and systems. The care and treatment process of cystic fibrosis disease requires a multidisciplinary approach. Regular exercise (as it is an important component of therapeutic treatment) improves respiratory function in children with cystic fibrosis. However, the treatment burden of the disease in the child and the serious respiratory system complications caused by the Covid-19 infection during the pandemic process cause patients with cystic fibrosis to be in the high risk group. Since it is thought that it is difficult for children with cystic fibrosis to exercise during the pandemic process, home exercise programs have gained importance. With the developing technology, patients are consulted remotely, training and consultancy services are provided and they can be followed continuously through phone calls and video conferences. Nurses are an important part of the multidisciplinary team responsible for the protection, development and maintenance of the health of the individual in every period of life. They have assumed the roles of educator, consultant, decision-maker, therapeutic, caregiver and researcher in order to protect the quality of life of children with exercise programs and to ensure that they lead an active life. In order for nurses to make exercise a part of the lives of children with cystic fibrosis, they should determine the knowledge level, awareness and needs of children and their families, and provide adequate and effective counseling so that they can meet their individual needs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| Tele-exercise program to Child with Cystic Fibrosis | Experimental | Behavioral: Tele-Exercise Program, Behavioral: Just observationInclusion criteria were "Voluntary to participate in the study", "Getting consent from parents", "Being a child with cystic fibrosis between the ages of 10-18", "Having no psychological health problems", "No physical problems that would prevent the child from exercising" and "Computer/ owning a smart phone and being able to use these devices", "Having an internet connection at home". The exclusion criteria were "Not volunteering to participate in the study", "Not being able to get consent from their parents", "Being under the age of 10 or over the age of 18 with a diagnosis of Cystic Fibrosis", "Having a psychological health problem", "Having a physical problem that prevents the child from exercising" and "Not having a computer/smart phone and not being able to use these devices" and "Not having an internet connection at home". Exclusion criteria are "Not participating in the exercise regularly (at least 2 times)", "Not wanting to continue working out". |
| Without exercise Child with Cystic Fibrosis | Experimental | Behavioral: Tele-Exercise Program, Behavioral: Just observationInclusion criteria were "Voluntary to participate in the study", "Getting consent from parents", "Being a child with cystic fibrosis between the ages of 10-18", "Having no psychological health problems", "No physical problems that would prevent the child from exercising" and "Computer/ owning a smart phone and being able to use these devices", "Having an internet connection at home". The exclusion criteria were "Not volunteering to participate in the study", "Not being able to get consent from their parents", "Being under the age of 10 or over the age of 18 with a diagnosis of Cystic Fibrosis", "Having a psychological health problem", "Having a physical problem that prevents the child from exercising" and "Not having a computer/smart phone and not being able to use these devices" and "Not having an internet connection at home". Exclusion criteria are "Not participating in the exercise regularly (at least 2 times)", "Not wanting to continue working out". |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Voluntary to participate in the study
- Getting consent from parents
- Being a child with cystic fibrosis between the ages of 10-18
- Having no psychological health problems
- No physical problems that would prevent the child from exercising"
Key exclusion criteria (9 listed)
- Not participating in the exercise regularly (at least 2 times)",
- Not wanting to continue working out".
- Not being willing to participate in the study
- Not being able to get consent from their parents
- Being under the age of 10, over the age of 18 with a diagnosis of Cystic Fibrosis
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 |
|---|---|---|
| Tele-Exercise ProgramData collection tools were applied to the tele-exercise group and control group at the beginning of the study. For the tele-exercise group, by the researcher, Exp. A 6-week exercise program was created under the consultancy of a physiotherapist. Children who met the research criteria were asked to do these exercises for 20 minutes, 3 times a week for 6 weeks. The exercises were performed online with the researcher at the scheduled time one day a week, and by the children twice a week. On the days they exercised, diaries consisting of semi-structured questions were sent to the children's addresses by cargo and they were allowed to keep a diary. Phone calls were made once a week to provide motivation and increase compliance with exercise. A smart watch was sent to the children by cargo to increase motivation. The children were asked to fill in the follow-up form, which was sent via weekly google forms. | Behavioural | Tele-exercise program to Child with Cystic Fibrosis, Without exercise Child with Cystic Fibrosis |
| Just observationStandard care was given to the children in the control group. | Behavioural | Tele-exercise program to Child with Cystic Fibrosis, Without exercise Child with Cystic Fibrosis |
Primary outcome
changing the quality of life
Time frame: Up to Six Weeks
changing the quality of life of children with cystic fibrosis after tele-exercise program
affects the symptoms
Time frame: Up to Six Weeks
affects the symptoms experienced by the children in the tele-exercise group during exercise.
2 secondary outcomes
changing the quality of life "Cystic Fibrosis Quality of Life Questionnaire"
Time frame: Up to Six Weeks
affects the symptoms during the tele-exercise
Time frame: Up to Six Weeks
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 20 Dec 2023.
- Background: PubMed 30324099Chen JJ, Cooper DM, Haddad F, Sladkey A, Nussbaum E, Radom-Aizik S. Tele-Exercise as a Promising Tool to Promote Exercise in Children With Cystic Fibrosis. Front Public Health. 2018 Sep 28;6:269. doi: 10.3389/fpubh.2018.00269. eCollection 2018.
- Background: PubMed 25425703Cox NS, Alison JA, Button BM, Wilson JW, Holland AE. Feasibility and acceptability of an internet-based program to promote physical activity in adults with cystic fibrosis. Respir Care. 2015 Mar;60(3):422-9. doi: 10.4187/respcare.03165. Epub 2014 Nov 25.
- Results publication: PubMed 16236893Quittner AL, Buu A, Messer MA, Modi AC, Watrous M. Development and validation of The Cystic Fibrosis Questionnaire in the United States: a health-related quality-of-life measure for cystic fibrosis. Chest. 2005 Oct;128(4):2347-54. doi: 10.1378/chest.128.4.2347.
- Individual participant dataSharing planned: No. other researhers may view the study once it is published.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-Exercise Program and Just observation in people with Cystic Fibrosis and Exercise Addiction, run by Ondokuz Mayıs 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 6 inclusion and 9 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 20 Dec 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?
changing the quality of life (time frame: Up to Six Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05481190, which also lists 3 linked publications.
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 20 Dec 2023.