Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07411066
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Clinical Pilates on Physical and Psychosocial Outcomes in Individuals With Interstitial Lung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-06', 'studyFirstSubmitDate': '2026-01-31', 'studyFirstSubmitQcDate': '2026-02-06', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Six-Minute Walk Test Distance', 'timeFrame': 'Baseline (Week 0) and Week 8', 'description': 'Physical function will be assessed using the Six-Minute Walk Test (6MWT). Total walking distance will be recorded.'}, {'measure': 'Modified Medical Research Council Dyspnea Scale Score', 'timeFrame': 'Baseline (Week 0) and Week 8', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['interstitial lung disease', 'clinical pilates', 'pilates'], 'conditions': ['Interstitial Lung Disease (ILD)']}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nParticipants 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.\n\nThe 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.', 'detailedDescription': "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.\n\nAlthough 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.\n\nClinical 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.\n\nIn 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.\n\nThe 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 to 75 years.\n* Clinically confirmed diagnosis of interstitial lung disease (ILD) by a physician.\n* Clinically stable condition (no acute exacerbation or hospitalization related to ILD within the last 4 weeks).\n* On stable medical treatment and routine follow-up.\n* Able to walk and participate in low-to-moderate intensity exercise as determined by the clinician/physiotherapist.\n* Able to understand study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Coexisting chronic respiratory disease that may confound outcomes (e.g., COPD, uncontrolled asthma, bronchiectasis).\n* Acute exacerbation of ILD or hospitalization within the last 4 weeks.\n* Unstable cardiovascular disease or other medical conditions making exercise unsafe (e.g., unstable angina, recent myocardial infarction).\n* Severe neurological, musculoskeletal, or balance disorders limiting safe participation in exercise.\n* Pulmonary hypertension or oxygen dependency requiring unstable/high-flow support if judged unsafe for exercise participation by the treating clinician.\n* Current participation in another structured exercise / pulmonary rehabilitation program during the study period.\n* Major psychiatric disorder or cognitive impairment interfering with participation or adherence.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT07411066', 'briefTitle': 'Effects of Clinical Pilates on Physical and Psychosocial Outcomes in Individuals With Interstitial Lung Disease', 'organization': {'class': 'OTHER', 'fullName': 'Recep Tayyip Erdogan University'}, 'officialTitle': 'Effects of Clinical Pilates on Physical and Psychosocial Outcomes in Individuals With Interstitial Lung Disease', 'orgStudyIdInfo': {'id': '2025/012-1758'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinical Pilates Group', 'description': 'Participants will receive a structured Clinical Pilates program delivered by a trained physiotherapist, focusing on breathing control, posture, core stability, flexibility, and functional movement.', 'interventionNames': ['Behavioral: Clinical Pilates', 'Other: standart care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care Control Group', 'description': 'Participants will receive standard medical care for interstitial lung disease without additional structured exercise or Clinical Pilates intervention.', 'interventionNames': ['Other: standart care']}], 'interventions': [{'name': 'Clinical Pilates', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Clinical Pilates Group']}, {'name': 'standart care', 'type': 'OTHER', 'description': 'Participants will continue their usual medical treatment and routine clinical follow-up for interstitial lung disease without additional rehabilitation intervention.', 'armGroupLabels': ['Clinical Pilates Group', 'Standard Care Control Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Recep Tayyip Erdogan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'İstanbul Yeni Yüzyıl Üniversitesi', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Seda Karaca', 'investigatorAffiliation': 'Recep Tayyip Erdogan University'}}}}