COPD (Chronic Obstructive Pulmonary Disease)NCT07122544
Pulmonary Rehabilitation in Salt Chambers for Patients With COPD
A study testing Therapeutic stay in subterranean sanatorium chambers (microclimate therapy), Breathing exercises and General fitness exercises in people with COPD (Chronic Obstructive Pulmonary Disease), run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
Trial summary
Title: The Impact of Pulmonary Rehabilitation Conducted in Therapeutic Salt Chambers on the Clinical Condition of Patients with Chronic Obstructive Pulmonary Disease Background and Rationale: Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory disorder that significantly reduces patients' quality… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Therapeutic stay in subterranean sanatorium chambers (microclimate therapy), Breathing exercises and General fitness exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2025to 1 Jan 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD diagnosis confirmed by a pulmonology specialist according to the 2025 GOLD guidelines.
- FEV1 ≥ 30% of the predicted value.
- FEV1/FVC < 0.7 after bronchodilator administration in spirometry.
- Negative bronchodilator reversibility test.
- Voluntary written consent to participate in the study.
Who cannot join
- COPD exacerbation.
- Active cancer or a history of cancer within the past five years.
- Musculoskeletal disorders preventing independent movement and participation in exercise tests and training included in the study protocol.
- Recent (within six months) surgical procedure or trauma to the chest, abdomen, skull, brain, or eye area.
- Severe valvular heart disease.
- Implanted cardioverter-defibrillator.
Show all 17Show fewer
- Diagnosed arrhythmias posing a risk of loss of consciousness.
- Acute coronary artery disease.
- Epilepsy.
- Uncontrolled arterial hypertension despite medication.
- Primary or secondary immunodeficiencies.
- Respiratory failure requiring chronic or intermittent oxygen therapy.
- Infectious diseases with fever during the experiment or within two weeks before the study.
- Claustrophobia.
- Pregnancy.
- Simultaneous participation in another rehabilitation program.
- Significant changes in pharmacological treatment during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
AKF Kraków
Krakow, Małopolska, 30-009
Paweł Janus, master, *48 502189055, pawel.janus@doctoral.awf.krakow.pl
About this study
Official title: The Impact of Pulmonary Rehabilitation Conducted in Therapeutic Salt Chambers on the Clinical Status of Patients With Chronic Obstructive Pulmonary Disease (COPD)
Title: The Impact of Pulmonary Rehabilitation Conducted in Therapeutic Salt Chambers on the Clinical Condition of Patients with Chronic Obstructive Pulmonary Disease
Background and Rationale:
Read more
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory disorder that significantly reduces patients' quality of life and functional capacity. In the search for supportive therapeutic strategies, there is growing interest in unconventional therapeutic environments such as therapeutic salt chambers. The underground climate of the "Wieliczka" Salt Mine in Poland - characterized by humidity 60-75%, temperature 12.9-14.5°C, high air purity and ionization - has shown therapeutic potential. However, the clinical effects of pulmonary rehabilitation conducted in such an environment in COPD patients remain insufficiently documented.
Study Objective:
To evaluate the effect of pulmonary rehabilitation and climatic therapy conducted in underground salt chambers on the clinical condition of patients with stable COPD.
Research Question:
Does pulmonary rehabilitation conducted in a subterranean salt mine environment offer measurable clinical benefits compared to standard surface-based rehabilitation?
Study Design and Methods:
This is a randomized, controlled, four-arm interventional study including 80 adult patients with a confirmed diagnosis of COPD according to the GOLD 2025 criteria. Participants will be randomly assigned to one of four groups:
Group A: Pulmonary rehabilitation in underground therapeutic salt chambers (physical training + microclimate exposure).
Group B: Pulmonary rehabilitation in a surface-level gymnasium (physical training without microclimate exposure).
Group C: Passive stay in underground salt chambers (microclimate exposure without physical training).
Group D: Health education only (control group, surface level).
The intervention program consists of 16 consecutive working days of 3-hour daily sessions. The content of the rehabilitation varies depending on the assigned group and includes general conditioning exercises, respiratory exercises, relaxation training, and health education.
Outcome Measures and Assessment Tools:
Clinical assessments will be conducted at three time points: prior to the intervention (T0), immediately after the intervention (T1), and at a 3-month follow-up (T2 - for Groups A and B only). The monitored variables include:
Exercise Tolerance: Incremental Shuttle Walk Test (ISWT)
Health-Related Quality of Life: St. George's Respiratory Questionnaire
COPD Symptoms and Risk Indexes: COPD Assessment Test (CAT), BODE Index
Muscle Strength: Deadlift test, hand dynamometer, 30-second Chair Stand Test
Respiratory Muscle Strength: Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP)
Body Composition: Bioelectrical Impedance Analysis (BIA)
Dyspnea Scales: Borg Scale, modified Medical Research Council (mMRC) scale
Chest Mobility: Measuring tape assessment
The study is designed to evaluate both the immediate and long-term effects of different pulmonary rehabilitation models on clinical outcomes in COPD patients, with a focus on whether the underground environment enhances rehabilitation efficacy.
- Being tested
- Therapeutic stay in subterranean sanatorium chambers (microclimate therapy), Breathing exercises, General fitness exercises, Relaxation training, Health education
- Keywords
- speleotherapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic stay in subterranean sanatorium chambers (microclimate therapy)Behavioural
Characteristics of the underground environment in the Wieliczka sanatorium chambers:
Stable climatic conditions: relative humidity ranging from 60-75%, temperature between 12.9-14.5°C; High chemical and biological air purity; Mineral content in the air: 2.7-8.1 mg/m³, consisting mainly of chloride, sodium, potassium, calcium, and fluoride ions; Air ionization: 1,200-4,700 aeroions/cm³ of air. Elevated atmospheric pressure: increased by approximately 16-20 mmHg compared to surface conditions.
Breathing exercisesBehavioural
30 minutes daily. Breathing exercises will include active respiratory exercises, drainage and effective coughing techniques, resistance training of the respiratory muscles, chest mobilization and relaxation exercises, breathing through pursed lips, as well as short and prolonged exhalation exercises.
General fitness exercisesBehavioural
30 minutes daily. General conditioning exercises will incorporate components aimed at improving overall aerobic capacity (e.g., walking-based activities, dance routines, step exercises), flexibility and coordination (e.g., stretching and balance exercises), and strength (e.g., exercises using resistance bands or dumbbells). The training will be conducted in interval, circuit, and free-form formats. Resistance levels will be individually adjusted to the patient's capacity.
Relaxation trainingBehavioural
30 minutes, once during the entire cycle. Relaxation training will include rest in a seated position, with dimmed lighting and calming music.
Health educationBehavioural
Educational materials in printed form for distribution covering the following topics:
COPD - information about the disease;
Breathing exercises and bronchial hygiene;
Benefits of physical activity, including examples of exercises that can be performed at home.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Rehabilitation in Salt Chambers | Experimental | Participants undergo a 16-day pulmonary rehabilitation program conducted in therapeutic salt chambers. The intervention includes general fitness, respiratory and relaxation exercises, health education. Conducted under supervision of a multidisciplinary team (physiotherapist, nurse, dietitian, physician). Sessions take place in the underground salt chambers of the "Wessel" complex (Salt Mine 'Wieliczka', Wieliczka, Poland). Receives: Behavioral: Therapeutic stay in subterranean sanatorium chambers (microclimate therapy); Behavioral: Breathing exercises; Behavioral: General fitness exercises; Behavioral: Relaxation training; Behavioral: Health education |
| Surface Rehabilitation | Active comparator | Participants undergo the same 16-day pulmonary rehabilitation program as in Arm 1, but conducted in standard surface conditions without exposure to salt chamber microclimate. Receives: Behavioral: Breathing exercises; Behavioral: General fitness exercises; Behavioral: Relaxation training; Behavioral: Health education |
| Passive Stay in Salt Chambers | Experimental | Participants attend daily 180-minutes passive sessions in therapeutic salt chambers for 16 days, without any physical exercise component. Receives: Behavioral: Therapeutic stay in subterranean sanatorium chambers (microclimate therapy); Behavioral: Health education |
| Health education only | Active comparator | Participants receive printed materials and general health education related to COPD management. No supervised exercise or microclimatic exposure is included. Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in exercise tolerance (ISWT distance)
Incremental Shuttle Walk Test (ISWT) used to assess functional exercise tolerance in COPD patients. Measured as distance walked in meters. Evaluates change from baseline to post-intervention and at 3-month follow-up to assess immediate and sustained effects of rehabilitation.
Measured: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Change in quality of life (SGRQ-C total score)
St. George's Respiratory Questionnaire version COPD (SGRQ-C) measures disease-specific quality of life.
Measured: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Secondary outcomes (6)
Change in Respiratory Muscle Strength
Respiratory Muscle Strength: Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP)
Measured: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Change in Chest Mobility
Measured using thoracic expansion assessment during respiration.
Measured: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Change in COPD Symptoms Severity
Evaluated using the COPD Assessment Test (CAT).
Measured: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Change in Dyspnea Severity
Measured using the Modified Medical Research Council (mMRC) Dyspnea Scale and Borg Dyspnea Scale.
Measured: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Change in Muscle Strength
Assessed with the 30-Second Chair Stand Test (30sCST), handgrip dynamometry, and deadlift strength test.
Measured: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Thigh circumference
Circumferential measurement of both thighs at their widest point with a tailor's tape measure.
Measured: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Sep 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University School of Physical Education, Krakow, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122544
- Sponsor's protocol ID
- 169/MN/SD/2025
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pulmonary Rehabilitation Conducted in Therapeutic Salt Chambers on the Clinical Status of Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT07122544
- Acronym / sponsor ID
- 169/MN/SD/2025
- Keywords
- speleotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University School of Physical Education, Krakow, PolandUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 14 Aug 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.
Title: The Impact of Pulmonary Rehabilitation Conducted in Therapeutic Salt Chambers on the Clinical Condition of Patients with Chronic Obstructive Pulmonary Disease
Background and Rationale:
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory disorder that significantly reduces patients' quality of life and functional capacity. In the search for supportive therapeutic strategies, there is growing interest in unconventional therapeutic environments such as therapeutic salt chambers. The underground climate of the "Wieliczka" Salt Mine in Poland - characterized by humidity 60-75%, temperature 12.9-14.5°C, high air purity and ionization - has shown therapeutic potential. However, the clinical effects of pulmonary rehabilitation conducted in such an environment in COPD patients remain insufficiently documented.
Study Objective:
To evaluate the effect of pulmonary rehabilitation and climatic therapy conducted in underground salt chambers on the clinical condition of patients with stable COPD.
Research Question:
Does pulmonary rehabilitation conducted in a subterranean salt mine environment offer measurable clinical benefits compared to standard surface-based rehabilitation?
Study Design and Methods:
This is a randomized, controlled, four-arm interventional study including 80 adult patients with a confirmed diagnosis of COPD according to the GOLD 2025 criteria. Participants will be randomly assigned to one of four groups:
Group A: Pulmonary rehabilitation in underground therapeutic salt chambers (physical training + microclimate exposure).
Group B: Pulmonary rehabilitation in a surface-level gymnasium (physical training without microclimate exposure).
Group C: Passive stay in underground salt chambers (microclimate exposure without physical training).
Group D: Health education only (control group, surface level).
The intervention program consists of 16 consecutive working days of 3-hour daily sessions. The content of the rehabilitation varies depending on the assigned group and includes general conditioning exercises, respiratory exercises, relaxation training, and health education.
Outcome Measures and Assessment Tools:
Clinical assessments will be conducted at three time points: prior to the intervention (T0), immediately after the intervention (T1), and at a 3-month follow-up (T2 - for Groups A and B only). The monitored variables include:
Exercise Tolerance: Incremental Shuttle Walk Test (ISWT)
Health-Related Quality of Life: St. George's Respiratory Questionnaire
COPD Symptoms and Risk Indexes: COPD Assessment Test (CAT), BODE Index
Muscle Strength: Deadlift test, hand dynamometer, 30-second Chair Stand Test
Respiratory Muscle Strength: Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP)
Body Composition: Bioelectrical Impedance Analysis (BIA)
Dyspnea Scales: Borg Scale, modified Medical Research Council (mMRC) scale
Chest Mobility: Measuring tape assessment
The study is designed to evaluate both the immediate and long-term effects of different pulmonary rehabilitation models on clinical outcomes in COPD patients, with a focus on whether the underground environment enhances rehabilitation efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehabilitation in Salt Chambers | Experimental | Behavioral: Therapeutic stay in subterranean sanatorium chambers (microclimate therapy), Behavioral: Breathing exercises, Behavioral: General fitness exercises, Behavioral: Relaxation training, Behavioral: Health educationParticipants undergo a 16-day pulmonary rehabilitation program conducted in therapeutic salt chambers. The intervention includes general fitness, respiratory and relaxation exercises, health education. Conducted under supervision of a multidisciplinary team (physiotherapist, nurse, dietitian, physician). Sessions take place in the underground salt chambers of the "Wessel" complex (Salt Mine 'Wieliczka', Wieliczka, Poland). |
| Surface Rehabilitation | Active comparator | Behavioral: Breathing exercises, Behavioral: General fitness exercises, Behavioral: Relaxation training, Behavioral: Health educationParticipants undergo the same 16-day pulmonary rehabilitation program as in Arm 1, but conducted in standard surface conditions without exposure to salt chamber microclimate. |
| Passive Stay in Salt Chambers | Experimental | Behavioral: Therapeutic stay in subterranean sanatorium chambers (microclimate therapy), Behavioral: Health educationParticipants attend daily 180-minutes passive sessions in therapeutic salt chambers for 16 days, without any physical exercise component. |
| Health education only | Active comparator | Behavioral: Health educationParticipants receive printed materials and general health education related to COPD management. No supervised exercise or microclimatic exposure is included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COPD diagnosis confirmed by a pulmonology specialist according to the 2025 GOLD guidelines.
- FEV1 ≥ 30% of the predicted value.
- FEV1/FVC < 0.7 after bronchodilator administration in spirometry.
- Negative bronchodilator reversibility test.
- Voluntary written consent to participate in the study.
Key exclusion criteria (17 listed)
- COPD exacerbation.
- Active cancer or a history of cancer within the past five years.
- Musculoskeletal disorders preventing independent movement and participation in exercise tests and training included in the study protocol.
- Recent (within six months) surgical procedure or trauma to the chest, abdomen, skull, brain, or eye area.
- Severe valvular heart disease.
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 |
|---|---|---|
| Therapeutic stay in subterranean sanatorium chambers (microclimate therapy)Characteristics of the underground environment in the Wieliczka sanatorium chambers: Stable climatic conditions: relative humidity ranging from 60-75%, temperature between 12.9-14.5°C; High chemical and biological air purity; Mineral content in the air: 2.7-8.1 mg/m³, consisting mainly of chloride, sodium, potassium, calcium, and fluoride ions; Air ionization: 1,200-4,700 aeroions/cm³ of air. Elevated atmospheric pressure: increased by approximately 16-20 mmHg compared to surface conditions. | Behavioural | Passive Stay in Salt Chambers, Pulmonary Rehabilitation in Salt Chambers |
| Breathing exercises30 minutes daily. Breathing exercises will include active respiratory exercises, drainage and effective coughing techniques, resistance training of the respiratory muscles, chest mobilization and relaxation exercises, breathing through pursed lips, as well as short and prolonged exhalation exercises. | Behavioural | Pulmonary Rehabilitation in Salt Chambers, Surface Rehabilitation |
| General fitness exercises30 minutes daily. General conditioning exercises will incorporate components aimed at improving overall aerobic capacity (e.g., walking-based activities, dance routines, step exercises), flexibility and coordination (e.g., stretching and balance exercises), and strength (e.g., exercises using resistance bands or dumbbells). The training will be conducted in interval, circuit, and free-form formats. Resistance levels will be individually adjusted to the patient's capacity. | Behavioural | Pulmonary Rehabilitation in Salt Chambers, Surface Rehabilitation |
| Relaxation training30 minutes, once during the entire cycle. Relaxation training will include rest in a seated position, with dimmed lighting and calming music. | Behavioural | Pulmonary Rehabilitation in Salt Chambers, Surface Rehabilitation |
| Health educationEducational materials in printed form for distribution covering the following topics: COPD - information about the disease; Breathing exercises and bronchial hygiene; Benefits of physical activity, including examples of exercises that can be performed at home. | Behavioural | Health education only, Passive Stay in Salt Chambers, Pulmonary Rehabilitation in Salt Chambers, Surface Rehabilitation |
Primary outcome
Change in exercise tolerance (ISWT distance)
Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Incremental Shuttle Walk Test (ISWT) used to assess functional exercise tolerance in COPD patients. Measured as distance walked in meters. Evaluates change from baseline to post-intervention and at 3-month follow-up to assess immediate and sustained effects of rehabilitation.
Change in quality of life (SGRQ-C total score)
Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
St. George's Respiratory Questionnaire version COPD (SGRQ-C) measures disease-specific quality of life.
6 secondary outcomes
Change in Respiratory Muscle Strength
Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Change in Chest Mobility
Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Change in COPD Symptoms Severity
Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Change in Dyspnea Severity
Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Change in Muscle Strength
Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Thigh circumference
Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
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 26 Nov 2025.
Related trials for COPD (Chronic Obstructive Pulmonary Disease)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic stay in subterranean sanatorium chambers (microclimate therapy), Breathing exercises and General fitness exercises in people with COPD (Chronic Obstructive Pulmonary Disease), run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
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 5 inclusion and 17 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 26 Nov 2025. 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 Poland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in exercise tolerance (ISWT distance) (time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)). 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?
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 26 Nov 2025.