NCT07411066

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

January 31, 2026

Last Update Submit

February 6, 2026

Conditions

Keywords

interstitial lung diseaseclinical pilatespilates

Outcome Measures

Primary Outcomes (2)

  • Six-Minute Walk Test Distance

    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

    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

Study Arms (2)

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.

Behavioral: Clinical PilatesOther: 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.

Other: standart care

Interventions

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.

Clinical Pilates Group

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

Clinical Pilates GroupStandard Care Control Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 31, 2026

First Posted

February 13, 2026

Study Start

February 1, 2026

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.