Lung TransplantationNCT07065318
Lung Transplant Candidates: Effects of Aerobic vs. HIIT Training on ICF Assessments
A study testing LV-HIIT (Low-Volume High-Intensity Interval Training), MICT (Moderate-Intensity Continuous Training) and Ergometer cycle in people with Lung Transplantation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Lung transplantation is a crucial surgical intervention aimed at increasing survival rates in patients with end-stage lung diseases such as chronic obstructive pulmonary disease (COPD), cystic fibrosis, idiopathic pulmonary fibrosis, and pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- LV-HIIT (Low-Volume High-Intensity Interval Training), MICT (Moderate-Intensity Continuous Training) and Ergometer cycle
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being diagnosed with interstitial lung disease and being followed up at the Ankara City Hospital Chest Diseases Clinic,
- Being 18 years of age or older,
- Patients who are being followed up with a diagnosis of ILD according to the ATS/ERS 2022 international ILD guideline,
- Being on the lung transplant waiting list according to the International Society for Heart and Lung Transplantation and are being evaluated for listing and are being followed up by the chest diseases department (25-28),
- Being willing to participate in the exercise program regularly and volunteering to participate in the study,
- Patients who have dyspnea levels of 2 and above according to the Modified Medical Research Council dyspnea scale and are able to ambulate,
- Patients who receive long-term oxygen support will be included.
Who cannot join
- Patients with a history of exertional syncope,
- Patients in acute exacerbation,
- Patients with sarcoidosis,
- Patients with serious comorbidities that may limit exercise (e.g. musculoskeletal, neurological or cardiovascular problems) will not be included.
- Patients with an aortic aneurysm greater than 5.5 cm,
- Patients with cardiovascular impediments to exercise during cardiological evaluations prior to pulmonary rehabilitation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, 06000
Ankara Bilkent City Hospital H H, H
About this study
Official title: Comparison of the Effects of Continuous Aerobic Exercise Training and High-Intensity Interval Exercise Training on ICF-Based Assessments in Lung Transplant Candidates
Lung transplantation is a crucial surgical intervention aimed at increasing survival rates in patients with end-stage lung diseases such as chronic obstructive pulmonary disease (COPD), cystic fibrosis, idiopathic pulmonary fibrosis, and pulmonary hypertension. One of the most important determinants of health outcomes before and after lung transplantation is exercise capacity. An increase in the 6-minute walking distance (6MWD), which serves as a measure of functional exercise capacity, is associated with lower mortality rates in both pre- and post-transplantation settings. Therefore, effective rehabilitation programs are needed to enhance the exercise capacities of lung transplant candidates.
Pulmonary rehabilitation (PR) is a comprehensive program designed specifically for individuals with chronic respiratory diseases. PR aims to improve patients\' physical and psychological conditions through detailed assessments and personalized treatment plans. It can play a role in enhancing the preoperative exercise capacities of lung transplant candidates and improving their chances of successful health outcomes. However, lung transplant candidates often have more advanced lung disease and face greater challenges compared to typical patients undergoing PR, making the expected benefits more complex to achieve.
The primary aim of this study is to investigate the effects of high-intensity interval training (HIIT) in lung transplant candidates with interstitial lung disease (ILD). The first objective is to compare the physiological responses and effectiveness of HIIT and moderate-intensity continuous training (MICT) within the same exercise volume. The secondary aim is to evaluate the impact of HIIT on body structure and function, activity, and participation levels using ICF-based assessments.
Read the detailed description
Research Design This study employs a randomized controlled prospective design. The exercise training protocol consists of two main groups: high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT). The HIIT protocol includes high-intensity efforts performed in 30-second intervals, while the MICT protocol involves longer-duration, moderate-intensity exercise. The total training duration for both groups is planned for 8 weeks.
Participants will include individuals with interstitial lung disease who are on the waiting list for lung transplantation. They must agree to participate regularly in the exercise program. Power analysis indicated that a minimum of 10 participants per group is needed, leading to a total target of 20 participants.
Parameters to be Assessed The study will assess various parameters before and after the exercise training. These parameters include demographic information, exercise capacity, respiratory function, comorbidities, daily living activities, and quality of life.
Exercise capacity will be evaluated using the 6-minute walk test (6MWT). Respiratory functions will be measured through pulmonary function tests (PFT), capturing values such as forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and carbon monoxide diffusion capacity (DLCO). Comorbidities will be assessed using the Charlson Comorbidity Index, while daily living activities will be measured using the London Chest and St. George questionnaires.
Quality of life will be evaluated through various scales. For instance, the Tampa Kinesiophobia Scale will assess fear and anxiety levels in patients. Additionally, the FRAIL Scale will evaluate frailty, sarcopenia levels, and muscle strength.
Hypotheses
This study has four main hypotheses:
There is a significant difference between HIIT and MICT regarding the effects on body structure and function impairments, activity, and participation levels.
HIIT has a positive effect on respiratory function, exercise capacity, and quality of life.
HIIT has an effect on sarcopenia and frailty levels. HIIT impacts body structure and function impairments, activity, and participation levels.
Conclusion This study aims to evaluate the effects of high-intensity interval training in lung transplant candidates. The findings may contribute to optimizing pre-transplant rehabilitation processes and improving the overall health status of these patients. Furthermore, the applicability and effectiveness of such exercise protocols may lead to significant changes in clinical practice. The results of the research will shed light on the development of exercise rehabilitation programs and the treatment processes for lung disease patients.
- Conditions
- Lung Transplantation
- Being tested
- LV-HIIT (Low-Volume High-Intensity Interval Training), MICT (Moderate-Intensity Continuous Training), Ergometer cycle
- Keywords
- lung transplant candidates, exercise training, high intensity interval training, aerobic exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LV-HIIT (Low-Volume High-Intensity Interval Training)Behavioural
30-sec intervals at 85-100% peak workload, 30-sec rest at 40%, total 20-30 min.
MICT (Moderate-Intensity Continuous Training)Behavioural
Continuous cycling at 60-80% peak workload for 20-30 min.
Ergometer cycleDevice
Electronically Ergometer cycle custo ec5000, CustoMed used for all exercise sessions. Calibrated before each trial.
| Study group | Role | What they receive |
|---|---|---|
| LV-HIIT (Low-Volume High-Intensity Interval Training) | Experimental | The first randomly assigned group will perform 30 seconds of high-intensity exercise at 85-100% of their maximum workload, followed by 30 seconds of exercise at 40% of their maximum workload. This 30-second high-intensity exercise followed by 30 seconds of low-intensity exercise will be referred to as one cycle. A total of 20 cycles will be completed. Additionally, 2 minutes of low-intensity warm-up and cool-down exercises will be performed. Receives: Behavioral: LV-HIIT (Low-Volume High-Intensity Interval Training); Device: Ergometer cycle |
| MICT (Moderate-Intensity Continuous Training) | Active comparator | The second group determined as a result of randomization will exercise for 20-30 minutes at 60-80% of maximum workload. Exercise volume (duration × %Wpeak) matched between groups. Receives: Behavioral: MICT (Moderate-Intensity Continuous Training); Device: Ergometer cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary exercise capacity
Peak Work Rate (PWR) PWR is determined through a symptom-limited incremental bicycle ergometer test. Patients pedal at 10 W, increasing by 10 W each minute until fatigue or a workload of 50 W is reached, or a fatigue level of 9 on the modified Borg scale. Workload and heart rate are monitored, with maximum workload (Wpeak) and heart rate recorded at the end.
Measured: through study completion, an average of 1 year
Submaximal exercise capacity
-Minute Walk Test (6MWT) The 6MWT assesses exercise capacity in a 30-meter corridor by measuring the distance walked. It evaluates oxygen saturation, heart rate, and dyspnea using the Borg scale before and after the test. Participants walk at their own pace and can pause or use oxygen as needed.
Measured: through study completion, an average of 1 year
Secondary outcomes (8)
Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry (Liters)
FEV1 will be assessed via CosmedQuark PFT Q-Box, Italy following. Participants will perform ≥3 reproducible maneuvers; the highest value within 5% repeatability will be recorded and reported in liters. Values will be expressed as absolute liters and % predicted using equation.
Measured: through study completion, an average of 1 year
Fragility
Frail Frailty Scale It is a scale that evaluates the patient\'s fatigue, resistance, mobility, weight loss and other diseases by questioning them. The FRAIL scale, which consists of 5 items, receives 0 or 1 points according to the answers given by the patients, and a total of 0 points is considered as non-frail, 1-2 points as pre-frail and \>2 points as frail.
Measured: through study completion, an average of 1 year
Life Quality
St George Quality of Life Questionnaire
It is a scale that measures the quality of life specific to respiratory diseases. It consists of a total of 50 items, 8 of which question the patient\'s symptoms, 16 of which question the activities, and 26 of which question the effects of the disease. While evaluating the symptoms, the patient\'s level of shortness of breath, cough, and sputum respiratory discomfort are questioned. While evaluating the activity component, physical activities that cause shortness of breath or are restricted due to shortness of breath are questioned. While evaluating the effects of the disease, it includes factors such as work, occupation, keeping health under control, and discomfort during daily living activities. The 3 sections of the test are calculated separately and the total score is calculated. A score of 0 indicates normal, a score of 100 indicates maximum disability
Measured: through study completion, an average of 1 year
Kinesiophobia
The Tampa Scale for Kinesiophobia (TSK) is a validated 17-item questionnaire assessing fear of movement and reinjury in chronic pain patients, scored on a 4-point Likert scale (1=strongly disagree to 4=strongly agree). Total scores range from 17 (no kinesiophobia) to 68 (severe kinesiophobia), with scores ≥38 indicating clinically significant fear that may impair recovery.
Measured: through study completion, an average of 1 year
Muscle strength
Hand Grip Strength Jamar (Jamar®, California, USA) brand hand dynamometer, which is valid in clinical studies, will be used to measure hand grip strength.
Measured: through study completion, an average of 1 year
Balance
Timed-up and Go Test Test is a test performed to evaluate dynamic balance and functional mobility. A standardized chair, stopwatch and 3 meters of walking space are needed. The test begins while sitting in a chair, the individual gets up with the start command, walks 3 meters at normal walking speed, turns back and sits on the chair. Test completion time is recorded for scoring. Those who complete it in more than 15 seconds are considered to have impairment in daily living activities.
Measured: through study completion, an average of 1 year
Sarcopenia
SARC-F The SARC-F questionnaire is a self-reported screening tool for sarcopenia risk, based on five components: Strength, Assistance in walking, Rising from a chair, Climbing stairs, and Falls. It takes its name from the initials of the components. Each item is scored from 0 to 2, with a total score of ≥4 indicating a high risk. In this study, SARC-F will be used to assess sarcopenia risk at baseline and follow-up.
Measured: through study completion, an average of 1 year
Respiratory muscle strength
Maximum Inspiratory Pressure (MIP) (cmH₂O) Maximum Expiratory Pressure (MEP) (cmH₂O)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Nov 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
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 Lung TransplantationStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Model description
- There will be 2 groups in the study. Group 1 will do low volume high-intensity interval exercise training. Group 2 will receive moderate-intensity continuous aerobic exercise training.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulaş Ar, Ankara City Hospital Bilkent
- Investigators
- Hatice K Kılıc, Prof. Dr., Study chair, Ankara City Hospital BilkentEbru CK Calık Kutukcu, Prof. Dr., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065318
- Sponsor's protocol ID
- TABED-2-24-305
- Status last verified
- Sep 2026
- First submitted
- 21 Nov 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hume E, Ward L, Wilkinson M, Manifield J, Clark S, Vogiatzis I. Exercise training for lung transplant candidates and recipients: a systematic review. Eur Respir Rev. 2020 Oct 28;29(158):200053. doi: 10.1183/16000617.0053-2020. Print 2020 Dec 31.
PubMed 33115788
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Continuous Aerobic Exercise Training and High-Intensity Interval Exercise Training on ICF-Based Assessments in Lung Transplant Candidates
- ClinicalTrials.gov ID
- NCT07065318
- Acronym / sponsor ID
- TABED-2-24-305
- Conditions
- Lung Transplantation
- Keywords
- lung transplant candidates, exercise training, high intensity interval training, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Jul 2025 (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.
Lung transplantation is a crucial surgical intervention aimed at increasing survival rates in patients with end-stage lung diseases such as chronic obstructive pulmonary disease (COPD), cystic fibrosis, idiopathic pulmonary fibrosis, and pulmonary hypertension. One of the most important determinants of health outcomes before and after lung transplantation is exercise capacity. An increase in the 6-minute walking distance (6MWD), which serves as a measure of functional exercise capacity, is associated with lower mortality rates in both pre- and post-transplantation settings. Therefore, effective rehabilitation programs are needed to enhance the exercise capacities of lung transplant candidates.
Pulmonary rehabilitation (PR) is a comprehensive program designed specifically for individuals with chronic respiratory diseases. PR aims to improve patients\' physical and psychological conditions through detailed assessments and personalized treatment plans. It can play a role in enhancing the preoperative exercise capacities of lung transplant candidates and improving their chances of successful health outcomes. However, lung transplant candidates often have more advanced lung disease and face greater challenges compared to typical patients undergoing PR, making the expected benefits more complex to achieve.
The primary aim of this study is to investigate the effects of high-intensity interval training (HIIT) in lung transplant candidates with interstitial lung disease (ILD). The first objective is to compare the physiological responses and effectiveness of HIIT and moderate-intensity continuous training (MICT) within the same exercise volume. The secondary aim is to evaluate the impact of HIIT on body structure and function, activity, and participation levels using ICF-based assessments.
Detailed description
Research Design This study employs a randomized controlled prospective design. The exercise training protocol consists of two main groups: high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT). The HIIT protocol includes high-intensity efforts performed in 30-second intervals, while the MICT protocol involves longer-duration, moderate-intensity exercise. The total training duration for both groups is planned for 8 weeks.
Participants will include individuals with interstitial lung disease who are on the waiting list for lung transplantation. They must agree to participate regularly in the exercise program. Power analysis indicated that a minimum of 10 participants per group is needed, leading to a total target of 20 participants.
Parameters to be Assessed The study will assess various parameters before and after the exercise training. These parameters include demographic information, exercise capacity, respiratory function, comorbidities, daily living activities, and quality of life.
Exercise capacity will be evaluated using the 6-minute walk test (6MWT). Respiratory functions will be measured through pulmonary function tests (PFT), capturing values such as forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and carbon monoxide diffusion capacity (DLCO). Comorbidities will be assessed using the Charlson Comorbidity Index, while daily living activities will be measured using the London Chest and St. George questionnaires.
Quality of life will be evaluated through various scales. For instance, the Tampa Kinesiophobia Scale will assess fear and anxiety levels in patients. Additionally, the FRAIL Scale will evaluate frailty, sarcopenia levels, and muscle strength.
Hypotheses
This study has four main hypotheses:
There is a significant difference between HIIT and MICT regarding the effects on body structure and function impairments, activity, and participation levels.
HIIT has a positive effect on respiratory function, exercise capacity, and quality of life.
HIIT has an effect on sarcopenia and frailty levels. HIIT impacts body structure and function impairments, activity, and participation levels.
Conclusion This study aims to evaluate the effects of high-intensity interval training in lung transplant candidates. The findings may contribute to optimizing pre-transplant rehabilitation processes and improving the overall health status of these patients. Furthermore, the applicability and effectiveness of such exercise protocols may lead to significant changes in clinical practice. The results of the research will shed light on the development of exercise rehabilitation programs and the treatment processes for lung disease patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There will be 2 groups in the study. Group 1 will do low volume high-intensity interval exercise training. Group 2 will receive moderate-intensity continuous aerobic exercise training.
| Arm | Type | Receives |
|---|---|---|
| LV-HIIT (Low-Volume High-Intensity Interval Training) | Experimental | Behavioral: LV-HIIT (Low-Volume High-Intensity Interval Training), Device: Ergometer cycleThe first randomly assigned group will perform 30 seconds of high-intensity exercise at 85-100% of their maximum workload, followed by 30 seconds of exercise at 40% of their maximum workload. This 30-second high-intensity exercise followed by 30 seconds of low-intensity exercise will be referred to as one cycle. A total of 20 cycles will be completed. Additionally, 2 minutes of low-intensity warm-up and cool-down exercises will be performed. |
| MICT (Moderate-Intensity Continuous Training) | Active comparator | Behavioral: MICT (Moderate-Intensity Continuous Training), Device: Ergometer cycleThe second group determined as a result of randomization will exercise for 20-30 minutes at 60-80% of maximum workload. Exercise volume (duration × %Wpeak) matched between groups. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Being diagnosed with interstitial lung disease and being followed up at the Ankara City Hospital Chest Diseases Clinic,
- Being 18 years of age or older,
- Patients who are being followed up with a diagnosis of ILD according to the ATS/ERS 2022 international ILD guideline,
- Being on the lung transplant waiting list according to the International Society for Heart and Lung Transplantation and are being evaluated for listing and are being followed up by the chest diseases department (25-28),
- Being willing to participate in the exercise program regularly and volunteering to participate in the study,
Key exclusion criteria (6 listed)
- Patients with a history of exertional syncope,
- Patients in acute exacerbation,
- Patients with sarcoidosis,
- Patients with serious comorbidities that may limit exercise (e.g. musculoskeletal, neurological or cardiovascular problems) will not be included.
- Patients with an aortic aneurysm greater than 5.5 cm,
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 |
|---|---|---|
| LV-HIIT (Low-Volume High-Intensity Interval Training)30-sec intervals at 85-100% peak workload, 30-sec rest at 40%, total 20-30 min. | Behavioural | LV-HIIT (Low-Volume High-Intensity Interval Training) |
| MICT (Moderate-Intensity Continuous Training)Continuous cycling at 60-80% peak workload for 20-30 min. | Behavioural | MICT (Moderate-Intensity Continuous Training) |
| Ergometer cycleElectronically Ergometer cycle custo ec5000, CustoMed used for all exercise sessions. Calibrated before each trial. | Device | LV-HIIT (Low-Volume High-Intensity Interval Training), MICT (Moderate-Intensity Continuous Training) |
Primary outcome
Cardiopulmonary exercise capacity
Time frame: through study completion, an average of 1 year
Peak Work Rate (PWR) PWR is determined through a symptom-limited incremental bicycle ergometer test. Patients pedal at 10 W, increasing by 10 W each minute until fatigue or a workload of 50 W is reached, or a fatigue level of 9 on the modified Borg scale. Workload and heart rate are monitored, with maximum workload (Wpeak) and heart rate recorded at the end.
Submaximal exercise capacity
Time frame: through study completion, an average of 1 year
-Minute Walk Test (6MWT) The 6MWT assesses exercise capacity in a 30-meter corridor by measuring the distance walked. It evaluates oxygen saturation, heart rate, and dyspnea using the Borg scale before and after the test. Participants walk at their own pace and can pause or use oxygen as needed.
8 secondary outcomes
Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry (Liters)
Time frame: through study completion, an average of 1 year
Fragility
Time frame: through study completion, an average of 1 year
Life Quality
Time frame: through study completion, an average of 1 year
Kinesiophobia
Time frame: through study completion, an average of 1 year
Muscle strength
Time frame: through study completion, an average of 1 year
Balance
Time frame: through study completion, an average of 1 year
Sarcopenia
Time frame: through study completion, an average of 1 year
Respiratory muscle strength
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Results publication: PubMed 33115788Hume E, Ward L, Wilkinson M, Manifield J, Clark S, Vogiatzis I. Exercise training for lung transplant candidates and recipients: a systematic review. Eur Respir Rev. 2020 Oct 28;29(158):200053. doi: 10.1183/16000617.0053-2020. Print 2020 Dec 31.
- 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.
Hatice K Kılıc, Prof. Dr. study chair
Ankara City Hospital Bilkent
Ebru CK Calık Kutukcu, Prof. Dr. study director
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 LV-HIIT (Low-Volume High-Intensity Interval Training), MICT (Moderate-Intensity Continuous Training) and Ergometer cycle in people with Lung Transplantation, run by Ankara City Hospital Bilkent 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 7 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ulas A Ar, MSc (90 312-552-6000, ulas12ar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary exercise capacity (time frame: through study completion, an average of 1 year). 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 NCT07065318, 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 30 Sep 2026.