- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07411066
Effects of Clinical Pilates on Physical and Psychosocial Outcomes in Individuals With Interstitial Lung Disease
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Clinical Pilates Group
Participants will receive a structured Clinical Pilates program delivered by a trained physiotherapist, focusing on breathing control, posture, core stability, flexibility, and functional movement.
|
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.
Participants will continue their usual medical treatment and routine clinical follow-up for interstitial lung disease without additional rehabilitation intervention.
|
|
Active Comparator: Standard Care Control Group
Participants will receive standard medical care for interstitial lung disease without additional structured exercise or Clinical Pilates intervention.
|
Participants will continue their usual medical treatment and routine clinical follow-up for interstitial lung disease without additional rehabilitation intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (Week 0) and Week 8
|
|
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)
|
Baseline (Week 0) and Week 8
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/012-1758
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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