Cystic FibrosisNCT05147285
The Effect of Telerehabilitation on Functional Capacity, Oxidative Stress and Respiratory Parameters in Cystic Fibrosis
A study testing stabilization exercises, combined exercises and Physical activity recommendations in people with Cystic Fibrosis and Telerehabilitation, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effects of different exercise modalities applied with tele-rehabilitation on functional capacity, oxidative stress and respiratory parameters in children with cystic fibrosis Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cystic Fibrosis, Telerehabilitation
- What is being tested?
- stabilization exercises, combined exercises and Physical activity recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2020to 20 May 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 8-18 years with a diagnosis of cystic fibrosis (CF)
- Access to online exercise training
- Percent predicted of forced expiratory volume at one second (FEV1) > 40% in pulmonary function test
Who cannot join
- Being diagnosed with acute pulmonary exacerbation at the time of study and / or within the last month.
- Being physically or perceptually competent to exercise
- Patients with allergic bronchopulmonary aspergillosis (ABPA) who were treated with systemic steroid therapy
- Having FEV1 %< 40% at pulmonary function test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Exercise Modalities Applied by Tele Rehabilitation on Functional Capacity, Oxidative Stress and Respiratory Parameters in Cystic Fibrosis Children
The aim of this study is to examine the effects of different exercise modalities applied with tele-rehabilitation on functional capacity, oxidative stress and respiratory parameters in children with cystic fibrosis
Read the detailed description
Cystic fibrosis (CF) is the most common life-shortening autosomal recessive disease among populations of caucasians with a frequency of 1 in 2000 to 3000 live births. The most common problems in these patients are increased bronchial secretion, decreased exercise capacity, and shortness of breath. In addition to progressive respiratory disease, peripheral and respiratory muscle function impairments, inflammation, and contribute to the decrease in exercise capacity in CF patients. Recent studies show that increased oxidative stress and impaired oxidant / antioxidant capacity have an important role in disease progression in CF patients. CF childrens may be more physically inactive. Cystic fibrosis transmembrane regulator (CFTR) modulators, airway clearance therapies, chest physiotherapy and exercise trainings are treatment options in these populations. Regular exercise which is the component of pulmonary rehabilitation (PR), is recommended for patients with CF. Aerobic exercise may help to mobilize secretions, in addition to providing the other known benefits of exercise in healthy individuals. Despite the benefits of PR programmes, low participant uptake, high drop-out rates, financial and transportation difficulties reduced the attendance in these programs. Different telemedicine treatments have been developed to overcome these difficulties and reduce healthcare costs. In recent studies, shows that tele-exercise is a promising new approach to promote exercise in children with CF. Although different exercise modalities such as aerobic exercise training and strength training have been investigated in CF patients, there is no study to examine stabilization exercises in this populations. Also there is no study to evaluate the effect of exercise training on irisin. In addition, although it is known that acute exercise has positive effects on both oxidant and antioxidant markers in the pediatric population, the effect of long-term exercise on oxidative stress has not been adequately studied. The aim of this study is to examine the effect of different exercise training modalities applied with telerehabilitation method on functional capacity, oxidative stress and respiratory parameters in CF patients. . In the study, after measuring respiratory functions, exercise capacity, oxidative stress parameters, peripheral muscle functions, balance, posture, quality of life and physical activity questionnaire, 39 people will be divided into three groups. First group will be applied only online supervised stabilization exercises, Second group will be applied online supervised aerobic exercise training and stabilization exercises. And the third group, the physical activity importance will be explained and appropriate physical activity recommendations will be made. All outcome measures will be repeated after exercise training.
- Conditions
- Cystic Fibrosis, Telerehabilitation
- Being tested
- stabilization exercises, combined exercises, Physical activity recommendations
- Keywords
- exercise, oxidative stress, respiratory muscles
- 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.
stabilization exercisesOther
Patients will be applied only online supervised stabilization exercises three times a week for 8 weeks.
combined exercisesOther
Patients will be applied online supervised aerobic exercise training and stabilization exercises.Aerobic exercises will be performed for 8 weeks, for 30-45 minutes, at 65-75% of the maximum heart rate, 3 days a week, on the days when stabilization exercises are not performed.
Physical activity recommendationsOther
The importance of physical activity will be explained to the patients and appropriate physical activity recommendations will be made.
| Study group | Role | What they receive |
|---|---|---|
| Stabilization group | Experimental | Only stabilization exercises in patients with cystic fibrosis Receives: Other: stabilization exercises |
| combined group | Experimental | stabilization exercise and aerobic exercise training in patients with cystic fibrosis Receives: Other: combined exercises |
| control group | Experimental | physical activity recommendations in patients with cystic fibrosis Receives: Other: Physical activity recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
six minute walk test distance
Six-minute walk test distance is recorded
Measured: before the exercise training
six minute walk test distance
Six-minute walk test distance is recorded
Measured: eight week
shuttle walk test distance
shuttle walk test distance is recorded
Measured: before exercise training
shuttle walk test distance
shuttle walk test distance is recorded
Measured: eight week
Secondary outcomes (60)
Respiratory muscle strength
Respiratory muscle strength will be evaluated using mouth pressure device
Measured: before exercise training
Respiratory muscle strength
Respiratory muscle strength will be evaluated using mouth pressure device
Measured: eight week
Respiratory muscle endurance
Respiratory muscle endurance will be evaluated using constant load test
Measured: before exercise training
Respiratory muscle endurance
Respiratory muscle endurance will be evaluated using constant load test
Measured: eight week
Pulmonary functions-FVC
Forced vital capacity (FVC)
Measured: before exercise training
Pulmonary functions-FVC
Forced vital capacity (FVC)
Measured: eight week
Pulmonary functions-FEV1
Forced expiratory volume in the first second (FEV1)
Measured: before exercise training
Pulmonary functions-FEV1
Forced expiratory volume in the first second (FEV1)
Measured: eight week
Pulmonary functions-FEV1/FVC
FEV1/ FVC
Measured: before exercise training
Pulmonary functions-FEV1/FVC
FEV1/ FVC
Measured: eight week
Pulmonary functions-PEF
Peak Expiratory Flow (PEF)
Measured: before exercise training
Pulmonary functions-PEF
Peak Expiratory Flow (PEF)
Measured: eight week
Pulmonary functions-FEF25-75
Forced mid-expiratory flow (FEF25-75)
Measured: before exercise training
Pulmonary functions-FEF25-75
Forced mid-expiratory flow (FEF25-75)
Measured: eight week
Oxidative stress-MDA
Malondialdehyde (MDA) will be determined in the blood samples.
Measured: before exercise training
Oxidative stress-MDA
Malondialdehyde (MDA) will be determined in the blood samples.
Measured: eight week
Oxidative stress-SOD
Superoxide dismutase (SOD) will be determined in the blood samples.
Measured: before exercise training
Oxidative stress-SOD
Superoxide dismutase (SOD) will be determined in the blood samples.
Measured: eight week
Oxidative stress-CAT
Catalase (CAT) will be determined in the blood samples.
Measured: before exercise training
Oxidative stress-CAT
Catalase (CAT) will be determined in the blood samples.
Measured: eight week
Oxidative stress-PC
Protein carbonyl (PC) will be determined in the blood samples.
Measured: before exercise training
Oxidative stress-PC
Protein carbonyl (PC) will be determined in the blood samples.
Measured: eight week
Oxidative stress-TOS
Total oxidant status (TOS) will be determined in the blood samples.
Measured: before exercise training
Oxidative stress-TOS
Total oxidant status (TOS) will be determined in the blood samples.
Measured: eight week
Oxidative stress-TAS
Total antioxidant status(TAS) will be determined in the blood samples.
Measured: before exercise training
Oxidative stress-TAS
Total antioxidant status (TAS) will be determined in the blood samples.
Measured: eight week
Oxidative stress-oxidative stress index
Oxidative stress index (TOS/TAS)
Measured: before exercise training
Oxidative stress-oxidative stress index
Oxidative stress index (TOS/TAS)
Measured: eight week
Peripheral muscle strength
Peripheral muscle strength will be evaluated using dynamometer
Measured: before exercise training
Peripheral muscle strength
Peripheral muscle strength will be evaluated using dynamometer
Measured: eight week
crunch repetitions
number of crunch completed is recorded
Measured: before exercise training
crunch repetitions
number of crunch completed is recorded
Measured: eight week
squat repetitions
number of squats completed is recorded
Measured: before exercise training
squat repetitions
number of squats completed is recorded
Measured: eight 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: eight week
plank duration
duration of keeping plank position is recorded
Measured: before exercise training
plank duration
duration of keeping plank position is recorded
Measured: eight week
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: eight week
myokine assessment
irisin levels will be determined in the blood sample
Measured: before exercise training
myokine assessment
irisin levels will be determined in the blood sample
Measured: eight week
posture-Corbin
Posture will be evaluated using Corbin Postural Assessment scale. Lateral and posterior views will be assessed (0 = absent, 1 = mild, 2 = moderate, 3 = severe) and posture score will be determined as excellent (0-2), very good (3-4), good (5-7), fair (8-11) and poor (>12).
Measured: before exercise training
posture-Corbin
Posture will be evaluated using Corbin Postural Assessment scale. Lateral and posterior views will be assessed (0 = absent, 1 = mild, 2 = moderate, 3 = severe) and posture score will be determined as excellent (0-2), very good (3-4), good (5-7), fair (8-11) and poor (>12).
Measured: eight week
posture
Thoracic kyphosis and lumbar lordosis angles will be evaluated in the sagittal plane with spinal mouse device.
Measured: before exercise training
posture
Thoracic kyphosis and lumbar lordosis angles will be evaluated in the sagittal plane with spinal mouse device.
Measured: eight week
balance
Pediatric berg balance scale will be used. The scale consists of 14 parts. Each section is scored between 0-4. The highest score that can be obtained from the scale is 56.Higher score means a better outcome.
Measured: before exercise training
balance
Pediatric berg balance scale will be used. The scale consists of 14 parts. Each section is scored between 0-4. The highest score that can be obtained from the scale is 56.Higher score means a better outcome.
Measured: eight week
static balance
static balance will be evaluated functional reach test
Measured: before exercise training
static balance
static balance will be evaluated functional reach test
Measured: eight week
dynamic balance
Balance will be evaluated using one-legged standing test
Measured: before exercise training
dynamic balance
Balance will be evaluated using one-legged standing test
Measured: eight week
functional mobility
functional mobility will be evaluated time-up go test
Measured: before exercise training
functional mobility
functional mobility will be evaluated time-up go test
Measured: eight week
Mcgill core endurance test
Endurance of trunk muscles will be evaluated trunk flexor, trunk extensor and side plank test
Measured: before exercise training
Mcgill core endurance test
Endurance of trunk muscles will be evaluated trunk flexor, trunk extensor and side plank test
Measured: eight week
Quality of life assessment
Quality of life will be evaluated using the Cystic Fibrosis Questionnaire-Revised (CFQ-R).The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a disease-specific health-related quality of life (HRQOL) measure for children, adolescents with cystic fibrosis (CF). The questionnaire assess physical functioning, emotional functioning, social functioning, body image, eating disorders, treatment, respiratory symptoms and digestive symptoms.Score range is 0-100. Higher scores indicating higher health-related quality of life.
Measured: before exercise training
Quality of life assessment
Quality of life will be evaluated using the Cystic Fibrosis Questionnaire-Revised (CFQ-R).The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a disease-specific health-related quality of life (HRQOL) measure for children, adolescents with cystic fibrosis (CF). The questionnaire assess physical functioning, emotional functioning, social functioning, body image, eating disorders, treatment, respiratory symptoms and digestive symptoms.Score range is 0-100. Higher scores indicating higher health-related quality of life.
Measured: eight week
Physical activity assessment
Physical activity levels will be assessed by The Physical Activity Questionnaire. Score range is 1-5. Higher scores indicating higher physical activity
Measured: before exercise training
Physical activity assessment
Physical activity levels will be assessed by The Physical Activity Questionnaire. Score range is 1-5. Higher scores indicating higher physical activity
Measured: eight week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start22 Oct 2020
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 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
- 39 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
- NCT05147285
- Sponsor's protocol ID
- KA-20069
- Status last verified
- Apr 2024
- First submitted
- 31 Oct 2021
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kilic K, Vardar-Yagli N, Nayir-Buyuksahin H, Guzelkas I, Dogru D, Saglam M, Calik-Kutukcu E, Inal-Ince D, Emiralioglu N, Yalcin E, Ozcelik U, Kiper N. Exercise intolerance, oxidative stress, and irisin in pediatric cystic fibrosis: Can telehealth-based exercise training make a difference? Heart Lung. 2024 Nov-Dec;68:145-153. doi: 10.1016/j.hrtlng.2024.06.016. Epub 2024 Jul 8.
PubMed 38981171
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Exercise Modalities Applied by Tele Rehabilitation on Functional Capacity, Oxidative Stress and Respiratory Parameters in Cystic Fibrosis Children
- ClinicalTrials.gov ID
- NCT05147285
- Acronym / sponsor ID
- KA-20069
- Conditions
- Cystic Fibrosis, Telerehabilitation
- Keywords
- exercise, oxidative stress, respiratory muscles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 7 Dec 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 examine the effects of different exercise modalities applied with tele-rehabilitation on functional capacity, oxidative stress and respiratory parameters in children with cystic fibrosis
Detailed description
Cystic fibrosis (CF) is the most common life-shortening autosomal recessive disease among populations of caucasians with a frequency of 1 in 2000 to 3000 live births. The most common problems in these patients are increased bronchial secretion, decreased exercise capacity, and shortness of breath. In addition to progressive respiratory disease, peripheral and respiratory muscle function impairments, inflammation, and contribute to the decrease in exercise capacity in CF patients. Recent studies show that increased oxidative stress and impaired oxidant / antioxidant capacity have an important role in disease progression in CF patients. CF childrens may be more physically inactive. Cystic fibrosis transmembrane regulator (CFTR) modulators, airway clearance therapies, chest physiotherapy and exercise trainings are treatment options in these populations. Regular exercise which is the component of pulmonary rehabilitation (PR), is recommended for patients with CF. Aerobic exercise may help to mobilize secretions, in addition to providing the other known benefits of exercise in healthy individuals. Despite the benefits of PR programmes, low participant uptake, high drop-out rates, financial and transportation difficulties reduced the attendance in these programs. Different telemedicine treatments have been developed to overcome these difficulties and reduce healthcare costs. In recent studies, shows that tele-exercise is a promising new approach to promote exercise in children with CF. Although different exercise modalities such as aerobic exercise training and strength training have been investigated in CF patients, there is no study to examine stabilization exercises in this populations. Also there is no study to evaluate the effect of exercise training on irisin. In addition, although it is known that acute exercise has positive effects on both oxidant and antioxidant markers in the pediatric population, the effect of long-term exercise on oxidative stress has not been adequately studied. The aim of this study is to examine the effect of different exercise training modalities applied with telerehabilitation method on functional capacity, oxidative stress and respiratory parameters in CF patients. . In the study, after measuring respiratory functions, exercise capacity, oxidative stress parameters, peripheral muscle functions, balance, posture, quality of life and physical activity questionnaire, 39 people will be divided into three groups. First group will be applied only online supervised stabilization exercises, Second group will be applied online supervised aerobic exercise training and stabilization exercises. And the third group, the physical activity importance will be explained and appropriate physical activity recommendations will be made. All outcome measures will be repeated after exercise training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stabilization group | Experimental | Other: stabilization exercisesOnly stabilization exercises in patients with cystic fibrosis |
| combined group | Experimental | Other: combined exercisesstabilization exercise and aerobic exercise training in patients with cystic fibrosis |
| control group | Experimental | Other: Physical activity recommendationsphysical activity recommendations in patients with cystic fibrosis |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients aged 8-18 years with a diagnosis of cystic fibrosis (CF)
- Access to online exercise training
- Percent predicted of forced expiratory volume at one second (FEV1) > 40% in pulmonary function test
Key exclusion criteria (4 listed)
- Being diagnosed with acute pulmonary exacerbation at the time of study and / or within the last month.
- Being physically or perceptually competent to exercise
- Patients with allergic bronchopulmonary aspergillosis (ABPA) who were treated with systemic steroid therapy
- Having FEV1 %< 40% at pulmonary function test.
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 |
|---|---|---|
| stabilization exercisesPatients will be applied only online supervised stabilization exercises three times a week for 8 weeks. | Other | Stabilization group |
| combined exercisesPatients will be applied online supervised aerobic exercise training and stabilization exercises.Aerobic exercises will be performed for 8 weeks, for 30-45 minutes, at 65-75% of the maximum heart rate, 3 days a week, on the days when stabilization exercises are not performed. | Other | combined group |
| Physical activity recommendationsThe importance of physical activity will be explained to the patients and appropriate physical activity recommendations will be made. | Other | control group |
Primary outcome
six minute walk test distance
Time frame: before the exercise training
Six-minute walk test distance is recorded
six minute walk test distance
Time frame: eight week
Six-minute walk test distance is recorded
shuttle walk test distance
Time frame: before exercise training
shuttle walk test distance is recorded
shuttle walk test distance
Time frame: eight week
shuttle walk test distance is recorded
60 secondary outcomes
Respiratory muscle strength
Time frame: before exercise training
Respiratory muscle strength
Time frame: eight week
Respiratory muscle endurance
Time frame: before exercise training
Respiratory muscle endurance
Time frame: eight week
Pulmonary functions-FVC
Time frame: before exercise training
Pulmonary functions-FVC
Time frame: eight week
Pulmonary functions-FEV1
Time frame: before exercise training
Pulmonary functions-FEV1
Time frame: eight week
Pulmonary functions-FEV1/FVC
Time frame: before exercise training
Pulmonary functions-FEV1/FVC
Time frame: eight week
Pulmonary functions-PEF
Time frame: before exercise training
Pulmonary functions-PEF
Time frame: eight week
Pulmonary functions-FEF25-75
Time frame: before exercise training
Pulmonary functions-FEF25-75
Time frame: eight week
Oxidative stress-MDA
Time frame: before exercise training
Oxidative stress-MDA
Time frame: eight week
Oxidative stress-SOD
Time frame: before exercise training
Oxidative stress-SOD
Time frame: eight week
Oxidative stress-CAT
Time frame: before exercise training
Oxidative stress-CAT
Time frame: eight week
Oxidative stress-PC
Time frame: before exercise training
Oxidative stress-PC
Time frame: eight week
Oxidative stress-TOS
Time frame: before exercise training
Oxidative stress-TOS
Time frame: eight week
Oxidative stress-TAS
Time frame: before exercise training
Oxidative stress-TAS
Time frame: eight week
Oxidative stress-oxidative stress index
Time frame: before exercise training
Oxidative stress-oxidative stress index
Time frame: eight week
Peripheral muscle strength
Time frame: before exercise training
Peripheral muscle strength
Time frame: eight week
crunch repetitions
Time frame: before exercise training
crunch repetitions
Time frame: eight week
squat repetitions
Time frame: before exercise training
squat repetitions
Time frame: eight week
push-up repetitions
Time frame: before exercise training
push-up repetitions
Time frame: eight week
plank duration
Time frame: before exercise training
plank duration
Time frame: eight week
1 minute sit to stand test (STS) repetitions
Time frame: before exercise training
1 minute sit to stand test (STS) repetitions
Time frame: eight 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 25 Apr 2024.
- Derived from this study: PubMed 38981171Kilic K, Vardar-Yagli N, Nayir-Buyuksahin H, Guzelkas I, Dogru D, Saglam M, Calik-Kutukcu E, Inal-Ince D, Emiralioglu N, Yalcin E, Ozcelik U, Kiper N. Exercise intolerance, oxidative stress, and irisin in pediatric cystic fibrosis: Can telehealth-based exercise training make a difference? Heart Lung. 2024 Nov-Dec;68:145-153. doi: 10.1016/j.hrtlng.2024.06.016. Epub 2024 Jul 8.
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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 stabilization exercises, combined exercises and Physical activity recommendations in people with Cystic Fibrosis and Telerehabilitation, 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 3 inclusion and 4 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 25 Apr 2024. 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?
six minute walk test distance (time frame: before the exercise training). The study lists 4 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 NCT05147285, which also lists 1 linked publication.
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 25 Apr 2024.