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NCT Number: 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical Pilates

Behavioral

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 care

Other

Participants will continue their usual medical treatment and routine clinical follow-up for interstitial lung disease without additional rehabilitation intervention.

Primary outcomes

  1. 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.

  2. 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)

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University

Other

Collaborators

  • İstanbul Yeni Yüzyıl Üniversitesi

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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