Interstitial Lung Disease (ILD)NCT07411066
Effects of Clinical Pilates on Physical and Psychosocial Outcomes in Individuals With Interstitial Lung Disease
A study testing Clinical Pilates and standart care in people with Interstitial Lung Disease (ILD), run by Recep Tayyip Erdogan University.
Trial summary
This study aims to investigate the effects of Clinical Pilates on physical and psychosocial outcomes in individuals with interstitial lung disease (ILD). Interstitial lung disease is a group of chronic conditions that affect lung tissue and can lead to breathing difficulties, reduced physical capacity, fatigue, and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Interstitial Lung Disease (ILD)
- What is being tested?
- Clinical Pilates and standart care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 May 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 75 years.
- Clinically confirmed diagnosis of interstitial lung disease (ILD) by a physician.
- Clinically stable condition (no acute exacerbation or hospitalization related to ILD within the last 4 weeks).
- On stable medical treatment and routine follow-up.
- Able to walk and participate in low-to-moderate intensity exercise as determined by the clinician/physiotherapist.
- Able to understand study procedures and provide written informed consent.
Who cannot join
- Coexisting chronic respiratory disease that may confound outcomes (e.g., COPD, uncontrolled asthma, bronchiectasis).
- Acute exacerbation of ILD or hospitalization within the last 4 weeks.
- Unstable cardiovascular disease or other medical conditions making exercise unsafe (e.g., unstable angina, recent myocardial infarction).
- Severe neurological, musculoskeletal, or balance disorders limiting safe participation in exercise.
- Pulmonary hypertension or oxygen dependency requiring unstable/high-flow support if judged unsafe for exercise participation by the treating clinician.
- Current participation in another structured exercise / pulmonary rehabilitation program during the study period.
- Major psychiatric disorder or cognitive impairment interfering with participation or adherence.
- Pregnancy.
About this study
This study aims to investigate the effects of Clinical Pilates on physical and psychosocial outcomes in individuals with interstitial lung disease (ILD). Interstitial lung disease is a group of chronic conditions that affect lung tissue and can lead to breathing difficulties, reduced physical capacity, fatigue, and decreased quality of life.
In addition to medical treatment, exercise-based rehabilitation approaches may help individuals with ILD improve their physical function and overall well-being. Clinical Pilates is a structured exercise method that focuses on breathing control, posture, core stability, flexibility, and body awareness.
Read more
Participants in this study will be randomly assigned to either a Clinical Pilates group or a control group receiving standard care. The Clinical Pilates program will be delivered by a trained physiotherapist over several weeks through supervised sessions.
The main outcomes of this study include physical function, respiratory symptoms, quality of life, and psychological well-being. The results of this study are expected to provide evidence on whether Clinical Pilates can be an effective and safe supportive approach for pulmonary rehabilitation in individuals with interstitial lung disease.
Read the detailed description
This study is designed to evaluate the effectiveness of Clinical Pilates as a supportive rehabilitation approach for individuals with interstitial lung disease (ILD). ILD is a group of chronic and progressive lung disorders characterized by impaired gas exchange, reduced lung compliance, and exercise intolerance. Individuals with ILD commonly experience dyspnea, fatigue, decreased physical capacity, and psychosocial difficulties, which negatively affect daily functioning and quality of life.
Although pharmacological treatment is essential for disease management, pulmonary rehabilitation has been increasingly recognized as an important component of comprehensive care in ILD. Exercise-based interventions may improve functional capacity, symptom perception, and psychological well-being. However, evidence regarding specific structured exercise methods such as Clinical Pilates in individuals with ILD remains limited.
Clinical Pilates is a physiotherapist-guided exercise approach that emphasizes controlled breathing, postural alignment, core stability, flexibility, and body awareness. The method aims to enhance movement efficiency, improve respiratory control, and support both physical and mental well-being. Due to its low-impact and adaptable nature, Clinical Pilates may be particularly suitable for individuals with chronic respiratory conditions.
In this randomized controlled study, eligible participants will be randomly assigned to either a Clinical Pilates intervention group or a control group receiving standard care. The intervention will consist of supervised Clinical Pilates sessions delivered by a trained physiotherapist over a predefined period. The exercises will be individually adapted according to participants' functional capacity and clinical status.
The primary outcomes of the study include physical function and respiratory symptoms. Secondary outcomes include quality of life, psychological well-being, and psychosocial functioning. Outcome measures will be assessed at baseline and after completion of the intervention period.
The results of this study are expected to contribute to the evidence base for pulmonary rehabilitation in ILD and to clarify whether Clinical Pilates can serve as a safe, feasible, and effective complementary intervention to improve both physical and psychosocial health in this population.
- Conditions
- Interstitial Lung Disease (ILD)
- Being tested
- Clinical Pilates, standart care
- Keywords
- interstitial lung disease, clinical pilates, pilates
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical PilatesBehavioural
A supervised Clinical Pilates exercise program conducted by a physiotherapist, including breathing-focused, posture-based, and low-impact strengthening and flexibility exercises tailored to individuals with interstitial lung disease.
standart careOther
Participants will continue their usual medical treatment and routine clinical follow-up for interstitial lung disease without additional rehabilitation intervention.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Pilates Group | Experimental | Participants will receive a structured Clinical Pilates program delivered by a trained physiotherapist, focusing on breathing control, posture, core stability, flexibility, and functional movement. Receives: Behavioral: Clinical Pilates; Other: standart care |
| Standard Care Control Group | Active comparator | Participants will receive standard medical care for interstitial lung disease without additional structured exercise or Clinical Pilates intervention. Receives: Other: standart care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-Minute Walk Test Distance
Physical function will be assessed using the Six-Minute Walk Test (6MWT). Total walking distance will be recorded.
Measured: Baseline (Week 0) and Week 8
Modified Medical Research Council Dyspnea Scale Score
Respiratory symptom severity will be assessed using the Modified Medical Research Council (mMRC) Dyspnea Scale total score. Points (range 0-4; higher scores indicate worse dyspnea)
Measured: Baseline (Week 0) and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Disease (ILD)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups: a Clinical Pilates intervention group and a control group receiving standard care. Outcomes will be compared between groups at baseline and after completion of the intervention period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Collaborators
- İstanbul Yeni Yüzyıl Üniversitesi
- Responsible party
- Principal investigator, Seda Karaca, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411066
- Sponsor's protocol ID
- 2025/012-1758
- Status last verified
- Feb 2026
- First submitted
- 31 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly due to ethical and privacy considerations, as the data include sensitive personal and health-related information. Data will be used only for the purposes of the current study and stored in accordance with institutional and data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Clinical Pilates on Physical and Psychosocial Outcomes in Individuals With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07411066
- Acronym / sponsor ID
- 2025/012-1758
- Conditions
- Interstitial Lung Disease (ILD)
- Keywords
- interstitial lung disease, clinical pilates, pilates
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Collaborators
- İstanbul Yeni Yüzyıl Üniversitesi
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 13 Feb 2026 (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.
This study aims to investigate the effects of Clinical Pilates on physical and psychosocial outcomes in individuals with interstitial lung disease (ILD). Interstitial lung disease is a group of chronic conditions that affect lung tissue and can lead to breathing difficulties, reduced physical capacity, fatigue, and decreased quality of life.
In addition to medical treatment, exercise-based rehabilitation approaches may help individuals with ILD improve their physical function and overall well-being. Clinical Pilates is a structured exercise method that focuses on breathing control, posture, core stability, flexibility, and body awareness.
Participants in this study will be randomly assigned to either a Clinical Pilates group or a control group receiving standard care. The Clinical Pilates program will be delivered by a trained physiotherapist over several weeks through supervised sessions.
The main outcomes of this study include physical function, respiratory symptoms, quality of life, and psychological well-being. The results of this study are expected to provide evidence on whether Clinical Pilates can be an effective and safe supportive approach for pulmonary rehabilitation in individuals with interstitial lung disease.
Detailed description
This study is designed to evaluate the effectiveness of Clinical Pilates as a supportive rehabilitation approach for individuals with interstitial lung disease (ILD). ILD is a group of chronic and progressive lung disorders characterized by impaired gas exchange, reduced lung compliance, and exercise intolerance. Individuals with ILD commonly experience dyspnea, fatigue, decreased physical capacity, and psychosocial difficulties, which negatively affect daily functioning and quality of life.
Although pharmacological treatment is essential for disease management, pulmonary rehabilitation has been increasingly recognized as an important component of comprehensive care in ILD. Exercise-based interventions may improve functional capacity, symptom perception, and psychological well-being. However, evidence regarding specific structured exercise methods such as Clinical Pilates in individuals with ILD remains limited.
Clinical Pilates is a physiotherapist-guided exercise approach that emphasizes controlled breathing, postural alignment, core stability, flexibility, and body awareness. The method aims to enhance movement efficiency, improve respiratory control, and support both physical and mental well-being. Due to its low-impact and adaptable nature, Clinical Pilates may be particularly suitable for individuals with chronic respiratory conditions.
In this randomized controlled study, eligible participants will be randomly assigned to either a Clinical Pilates intervention group or a control group receiving standard care. The intervention will consist of supervised Clinical Pilates sessions delivered by a trained physiotherapist over a predefined period. The exercises will be individually adapted according to participants' functional capacity and clinical status.
The primary outcomes of the study include physical function and respiratory symptoms. Secondary outcomes include quality of life, psychological well-being, and psychosocial functioning. Outcome measures will be assessed at baseline and after completion of the intervention period.
The results of this study are expected to contribute to the evidence base for pulmonary rehabilitation in ILD and to clarify whether Clinical Pilates can serve as a safe, feasible, and effective complementary intervention to improve both physical and psychosocial health in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: a Clinical Pilates intervention group and a control group receiving standard care. Outcomes will be compared between groups at baseline and after completion of the intervention period.
| Arm | Type | Receives |
|---|---|---|
| Clinical Pilates Group | Experimental | Behavioral: Clinical Pilates, Other: standart careParticipants will receive a structured Clinical Pilates program delivered by a trained physiotherapist, focusing on breathing control, posture, core stability, flexibility, and functional movement. |
| Standard Care Control Group | Active comparator | Other: standart careParticipants will receive standard medical care for interstitial lung disease without additional structured exercise or Clinical Pilates intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 to 75 years.
- Clinically confirmed diagnosis of interstitial lung disease (ILD) by a physician.
- Clinically stable condition (no acute exacerbation or hospitalization related to ILD within the last 4 weeks).
- On stable medical treatment and routine follow-up.
- Able to walk and participate in low-to-moderate intensity exercise as determined by the clinician/physiotherapist.
Key exclusion criteria (8 listed)
- Coexisting chronic respiratory disease that may confound outcomes (e.g., COPD, uncontrolled asthma, bronchiectasis).
- Acute exacerbation of ILD or hospitalization within the last 4 weeks.
- Unstable cardiovascular disease or other medical conditions making exercise unsafe (e.g., unstable angina, recent myocardial infarction).
- Severe neurological, musculoskeletal, or balance disorders limiting safe participation in exercise.
- Pulmonary hypertension or oxygen dependency requiring unstable/high-flow support if judged unsafe for exercise participation by the treating clinician.
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 |
|---|---|---|
| Clinical PilatesA supervised Clinical Pilates exercise program conducted by a physiotherapist, including breathing-focused, posture-based, and low-impact strengthening and flexibility exercises tailored to individuals with interstitial lung disease. | Behavioural | Clinical Pilates Group |
| standart careParticipants will continue their usual medical treatment and routine clinical follow-up for interstitial lung disease without additional rehabilitation intervention. | Other | Clinical Pilates Group, Standard Care Control Group |
Primary outcome
Six-Minute Walk Test Distance
Time frame: Baseline (Week 0) and Week 8
Physical function will be assessed using the Six-Minute Walk Test (6MWT). Total walking distance will be recorded.
Modified Medical Research Council Dyspnea Scale Score
Time frame: Baseline (Week 0) and Week 8
Respiratory symptom severity will be assessed using the Modified Medical Research Council (mMRC) Dyspnea Scale total score. Points (range 0-4; higher scores indicate worse dyspnea)
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 13 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly due to ethical and privacy considerations, as the data include sensitive personal and health-related information. Data will be used only for the purposes of the current study and stored in accordance with institutional and data protection regulations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Pilates and standart care in people with Interstitial Lung Disease (ILD), run by Recep Tayyip Erdogan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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: Baseline (Week 0) and Week 8). 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 13 Feb 2026.