Cystic FibrosisNCT05590169
Effects of Telerehabilitation-based Exercises in Cystic Fibrosis
A study testing Exercise training in people with Cystic Fibrosis and Exercise, run by Istanbul Bilgi University at 2 sites in Turkey (Türkiye).
Trial summary
Pulmonary rehabilitation programs are an important part of lifelong therapy in the treatment of patients with cystic fibrosis. Although the possible benefits of exercise are known, physical activity levels and participation in exercise are low in patients with cystic fibrosis. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Exercise, Telerehabilitation
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 May 2023to 30 Jun 2024
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Being diagnosed with cystic fibrosis
- Being between the ages of 8-18
- Having a device for video calls (phone, computer, tablet, etc.)
Who cannot join
- Severe airway obstruction (FEV1 (%, predicted) <40%)
- Pulmonary exacerbation/hospitalization in the last four weeks
- History of lung transplant
- Orthopedic problems that limit exercise
- Those who had a change in their medical treatment during the study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul University-Cerrahpasa
Istanbul, Istanbul, 34500
Istanbul Bilgi University
Istanbul
About this study
Official title: Comparison of Effects of Telerehabilitation-based Individual and Group Exercises on Functional Capacity in Patients with Cystic Fibrosis
Pulmonary rehabilitation programs are an important part of lifelong therapy in the treatment of patients with cystic fibrosis. Although the possible benefits of exercise are known, physical activity levels and participation in exercise are low in patients with cystic fibrosis. There are barriers such as lack of time, demoralization, lack of motivation, and transportation problems. Although group exercises are an approach that increases participation and motivation, it is not considered a very suitable method because it increases the risk of cross infection in patients with cystic fibrosis when performed face-to-face. Telerehabilitation programs, which are increasingly used in chronic respiratory diseases, show similar results with clinical rehabilitation programs. Telerehabilitation programs, the effects of which have been examined in different disease groups in recent years, on patients with cystic fibrosis are limited in the literature. Group exercises that can be given with the telerehabilitation method may be a good approach for patients with cystic fibrosis, eliminating possible infection transmission.
The goal of this interventional clinical trial is to compare of effects of telerehabilitation based individual and group exercises on functional exercise capacity, muscle strength, respiratory functions, balance, anaerobic power, quality of life, and adherence in children with cystic fibrosis. The main question it aims to answer are:
Read more
- Is there a difference between functional exercise capacity, muscle strength, respiratory functions, balance, anaerobic performance, quality of life and compliance with treatment between telerehabilitation based group exercises and telerehabilitation based individual exercises in patients with cystic fibrosis?
Participants will be randomized into three groups:
Group 1: They will be divided into groups of four and included in the exercise training for eight weeks with telerehabilitation.
Group 2: They will be individually included in exercise training with telerehabilitation for eight weeks.
Group 3 (control group): They will continue their routine treatment (medical treatment, airway cleaning techniques, physical activity counseling).
- Conditions
- Cystic Fibrosis, Exercise, Telerehabilitation, Exercise Capacity
- Being tested
- Exercise training
- Keywords
- physiotherapy, cystic fibrosis, randomized controlled trial, telerehabilitation
- Medical subject headings
- Cystic Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Also called Telerehabilitation-based exercise
Group 1: Group exercises via Zoom application Group 2: Individual exercises via Zoom application Group 3: Routine treatment
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | They will be included in exercise training as a group (three or four participants) with telerehabilitation (via Zoom application) for eight weeks. Exercise program includes: (F) 3 times a week, (I) at 60-70% of the maximum heart rate, (T): breathing, stretching, aerobic, plyometric, balance exercises, (T) 30 minutes each session, a total of 8 week. During the exercise sessions, the heart rate will be monitored via a Polar Unite Fitness Watch, and the oxygen saturations will be monitored with a pulse oximeter. Receives: Other: Exercise training |
| Group 2 | Experimental | They will be individually included in exercise training with (via Zoom application) for eight weeks. Exercise program includes: (F) 3 times a week, (I) at 60-70% of the maximum heart rate, (T): breathing, stretching, aerobic, plyometric, balance exercises, (T) 30 minutes each session, a total of 8 week. During the exercise sessions, the heart rate will be monitored via a Polar Unite Fitness Watch, and the oxygen saturations will be monitored with a pulse oximeter. Receives: Other: Exercise training |
| Group 3 | No intervention | They will continue their routine treatment (medical treatment, airway cleaning techniques, physical activity counseling). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional exercise capacity
Six-minute walking test: Before the test, oxygen saturation, heart rate, blood pressure, dyspnea and fatigue measurements are recorded. The patient walks for six minutes as fast as they can walk on the ground for at least 30 meters. The walking distance is recorded in meters. If the patient stops during the test, the total time he stopped, the number of times he stopped is recorded. After the test, the evaluations made before the test are repeated.
Measured: 0-8 weeks
Functional exercise capacity
Modified shuttle walking test: It is a maximal test performed by adjusting walking speed with pre-recorded signals. Before the test, oxygen saturation, heart rate and blood pressure, dyspnea and fatigue will be recorded. The patient walks between two 10-meter points. Walking speed is increased every minute. The test is terminated when the required speed cannot be maintained or the speed cannot be followed. At the end of the test, the measurements are repeated.
Measured: 0-8 weeks
Secondary outcomes (6)
Muscle strength
For the peripheral muscle strength, the strength and grip strength of the knee extensor, hip flexor and abductor muscles in the lower extremity, and the elbow flexor, shoulder flexor and abductor muscles in the upper extremity will be examined. Measurement of muscle strength will be made with a Lafayette manual muscle tester, measurement of grip strength will be made with a Jamar hydraulic hand dynamometer. Evaluations will be made with the patient in a sitting position with back support. Evaluation of muscle strength will be done by evaluating the right and left extremities, and the grip strength will be repeated three times separately for the dominant hand and the non-dominant hand.
Measured: 0-8 weeks
Spirometric measurements
The measured and predictive (%) values of FEV1, forced vital capacity (FVC), FEV1/FVC ratio, peak expiratory flow (PEF) will be recorded from the results of the pulmonary function test performed in accordance with the American Thoracic Society/European Respiratory Society guidelines.
Measured: 0-8 weeks
Balance
Timed up and go test will use for balance assessment. The test, which starts with sitting in a chair, ends with walking a distance of three meters, turning and sitting on the chair again. The test completion time is recorded in seconds.
Measured: 0-8 weeks
Anaerobic performance
The anaerobic performance of the patients will be evaluated with the vertical jump test. The vertical jump test is an indicator of lower extremity explosive strength. When the patient jumps as high as possible, the distance achieved by the jump is recorded in meters. The test is repeated three times and the best performance is recorded.
Measured: 0-8 weeks
Health-related quality of life by questionnaire
The Pediatric Quality of Life Inventory (PedsQL) developed by Varni et al. will be used to evaluate the quality of life of the patients. The scale consists of 23 items in total. Eight of these items question physical, five emotional, five social, and five school functionality. The total score is calculated by scoring each item on a five-point Likert scale (0-4). The higher the score, the better the health-related quality of life.
Measured: 0-8 weeks
Adherence rate
An exercise diary will be given to monitor the patients' daily routine physiotherapy (airway cleaning techniques, physical activity, etc.). Sessions will be logged by patients and their families. At the end of the treatment, the continuity of the routine treatment will be calculated as % with the equation "routine treatment sessions x 100/total days". A record of participation in telerehabilitation-based supervised exercise sessions will be recorded by the physiotherapist. When the training is over, the adherence rate will be calculated as % with the equation "exercise sessionsx100/24".
Measured: When the exercise training is over (after eight weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start20 May 2023
- Primary completion31 May 2024
- Study completion30 Jun 2024
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.
- 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
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Cigdem Emirza, Istanbul Bilgi University
- Investigators
- Goksen Kuran Aslan, PT, phD, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590169
- Sponsor's protocol ID
- 05112022/96
- Status last verified
- Feb 2024
- First submitted
- 16 Oct 2022
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 30324099Stanford G, Daniels T, Brown C, Ferguson K, Prasad A, Agent P, Gates A, Morrison L. Role of the Physical Therapist in Cystic Fibrosis Care. Phys Ther. 2022 Dec 30;103(1):pzac136. doi: 10.1093/ptj/pzac136.
PubMed 36193006Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
PubMed 33511633
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Telerehabilitation-based Individual and Group Exercises on Functional Capacity in Patients with Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT05590169
- Acronym / sponsor ID
- 05112022/96
- Conditions
- Cystic Fibrosis, Exercise, Telerehabilitation, Exercise Capacity
- Keywords
- physiotherapy, cystic fibrosis, randomized controlled trial, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 20 May 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 21 Oct 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.
Pulmonary rehabilitation programs are an important part of lifelong therapy in the treatment of patients with cystic fibrosis. Although the possible benefits of exercise are known, physical activity levels and participation in exercise are low in patients with cystic fibrosis. There are barriers such as lack of time, demoralization, lack of motivation, and transportation problems. Although group exercises are an approach that increases participation and motivation, it is not considered a very suitable method because it increases the risk of cross infection in patients with cystic fibrosis when performed face-to-face. Telerehabilitation programs, which are increasingly used in chronic respiratory diseases, show similar results with clinical rehabilitation programs. Telerehabilitation programs, the effects of which have been examined in different disease groups in recent years, on patients with cystic fibrosis are limited in the literature. Group exercises that can be given with the telerehabilitation method may be a good approach for patients with cystic fibrosis, eliminating possible infection transmission.
The goal of this interventional clinical trial is to compare of effects of telerehabilitation based individual and group exercises on functional exercise capacity, muscle strength, respiratory functions, balance, anaerobic power, quality of life, and adherence in children with cystic fibrosis. The main question it aims to answer are:
- Is there a difference between functional exercise capacity, muscle strength, respiratory functions, balance, anaerobic performance, quality of life and compliance with treatment between telerehabilitation based group exercises and telerehabilitation based individual exercises in patients with cystic fibrosis?
Participants will be randomized into three groups:
Group 1: They will be divided into groups of four and included in the exercise training for eight weeks with telerehabilitation.
Group 2: They will be individually included in exercise training with telerehabilitation for eight weeks.
Group 3 (control group): They will continue their routine treatment (medical treatment, airway cleaning techniques, physical activity counseling).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Exercise trainingThey will be included in exercise training as a group (three or four participants) with telerehabilitation (via Zoom application) for eight weeks. Exercise program includes: (F) 3 times a week, (I) at 60-70% of the maximum heart rate, (T): breathing, stretching, aerobic, plyometric, balance exercises, (T) 30 minutes each session, a total of 8 week. During the exercise sessions, the heart rate will be monitored via a Polar Unite Fitness Watch, and the oxygen saturations will be monitored with a pulse oximeter. |
| Group 2 | Experimental | Other: Exercise trainingThey will be individually included in exercise training with (via Zoom application) for eight weeks. Exercise program includes: (F) 3 times a week, (I) at 60-70% of the maximum heart rate, (T): breathing, stretching, aerobic, plyometric, balance exercises, (T) 30 minutes each session, a total of 8 week. During the exercise sessions, the heart rate will be monitored via a Polar Unite Fitness Watch, and the oxygen saturations will be monitored with a pulse oximeter. |
| Group 3 | No intervention | –They will continue their routine treatment (medical treatment, airway cleaning techniques, physical activity counseling). |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Being diagnosed with cystic fibrosis
- Being between the ages of 8-18
- Having a device for video calls (phone, computer, tablet, etc.)
Key exclusion criteria (5 listed)
- Severe airway obstruction (FEV1 (%, predicted) <40%)
- Pulmonary exacerbation/hospitalization in the last four weeks
- History of lung transplant
- Orthopedic problems that limit exercise
- Those who had a change in their medical treatment during the study
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 |
|---|---|---|
| Exercise trainingAlso: Telerehabilitation-based exerciseGroup 1: Group exercises via Zoom application Group 2: Individual exercises via Zoom application Group 3: Routine treatment | Other | Group 2, Group I |
Primary outcome
Functional exercise capacity
Time frame: 0-8 weeks
Six-minute walking test: Before the test, oxygen saturation, heart rate, blood pressure, dyspnea and fatigue measurements are recorded. The patient walks for six minutes as fast as they can walk on the ground for at least 30 meters. The walking distance is recorded in meters. If the patient stops during the test, the total time he stopped, the number of times he stopped is recorded. After the test, the evaluations made before the test are repeated.
Functional exercise capacity
Time frame: 0-8 weeks
Modified shuttle walking test: It is a maximal test performed by adjusting walking speed with pre-recorded signals. Before the test, oxygen saturation, heart rate and blood pressure, dyspnea and fatigue will be recorded. The patient walks between two 10-meter points. Walking speed is increased every minute. The test is terminated when the required speed cannot be maintained or the speed cannot be followed. At the end of the test, the measurements are repeated.
6 secondary outcomes
Muscle strength
Time frame: 0-8 weeks
Spirometric measurements
Time frame: 0-8 weeks
Balance
Time frame: 0-8 weeks
Anaerobic performance
Time frame: 0-8 weeks
Health-related quality of life by questionnaire
Time frame: 0-8 weeks
Adherence rate
Time frame: When the exercise training is over (after eight 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 24 Mar 2025.
- 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 36193006Stanford G, Daniels T, Brown C, Ferguson K, Prasad A, Agent P, Gates A, Morrison L. Role of the Physical Therapist in Cystic Fibrosis Care. Phys Ther. 2022 Dec 30;103(1):pzac136. doi: 10.1093/ptj/pzac136.
- Background: PubMed 33511633Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
- 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.
Goksen Kuran Aslan, PT, phD study director
Istanbul University - Cerrahpasa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Cystic Fibrosis and Exercise, run by Istanbul Bilgi University at 2 sites 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 3 inclusion and 5 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 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Functional exercise capacity (time frame: 0-8 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 NCT05590169, 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 24 Mar 2025.