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Recruiting NCT06527612

The Effect of Exercise Training on Quality of Life and Disease Progression in Fibrosing Interstitial Lung Patients

No phase Interventional Fibrosis, Pulmonary Pulmonary Rehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pulmonary rehabilitation exercise programme.
Who it may be relevant to
Registry conditions: Fibrosis, Pulmonary, Pulmonary Rehabilitation. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

In this study, the progression of the disease and changes in quality of life will be examined over a 1-year follow-up period in groups of patients with Fibrosing Interstitial Lung Disease who either participated in or did not participate in a pulmonary rehabilitation program. After the initial evaluation, the patients will be randomized into two groups: one serving as the control group and the other as the pulmonary rehabilitation exercise group.

Detailed description

Patients diagnosed with fibrosing lung disease by a pulmonology specialist at Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital will be included in the study. Those meeting the inclusion criteria will be randomized into two groups: the Exercise Group (EGr) and the Control Group (CGr). After the initial evaluation, patients will be assessed at 3, 6, and 12 months. They will be called back to the hospital for follow-up evaluations. In addition to standard medical treatment, the EGr will undergo an exercise program. The initial exercise training will be conducted in the hospital, followed by online exercise sessions via video conferencing three times a week during the first week. From the second week onwards, they will be asked to perform their exercises at home three times a week using provided exercise videos and will be monitored for one year. Compliance with the exercise regimen will be assessed through a weekly survey shared in a WhatsApp group established for the exercise group patients. Patients in the CGr will receive an information brochure containing medical treatment and physical activity recommendations

Interventions

  • Other Pulmonary rehabilitation exercise programme
    In addition to standard medical treatment, the EGr will undergo an exercise program. The initial exercise training will be conducted in the hospital, followed by online exercise sessions via video conferencing three times a week during the first week. From the second week onwards, they will be asked to perform their exercises at home three times a week using provided exercise videos and will be monitored for one year. Compliance with the exercise regimen will be assessed through a weekly survey

Primary outcome measures

  • Saint George Quality of life questionnaire [Time frame: Baseline, at 3rd, 6th and 12th months after the intervention]
  • Forced vital capacity [Time frame: Baseline, at 3rd, 6th and 12th months after the intervention]
  • Diffusing Capacity of the Lungs for Carbon Monoxide [Time frame: Baseline, at 3rd, 6th and 12th months after the intervention]
  • Peripheral oxygen saturation [Time frame: Baseline, at 3rd, 6th and 12th months after the intervention]
Secondary outcome measures (4)
  • Six minute walking test [Time frame: Baseline, at 3rd, 6th and 12th months after the intervention]
  • Peripheral muscle strength [Time frame: Baseline, at 3rd, 6th and 12th months after the intervention]
  • Modified Medical Research Council Dyspnea Score [Time frame: Baseline, at 3rd, 6th and 12th months after the intervention]
  • Leicester cough questionnaire [Time frame: Baseline, at 3rd, 6th and 12th months after the intervention]

Eligibility criteria

Inclusion criteria

  • Aged between 18-75 years
  • Diagnosed with fibrosing interstitial lung disease according to the clinical diagnostic criteria of the American Thoracic Society and European Respiratory Society (ATS-ERS)
  • Presence of dyspnea on exertion
  • Stable clinical condition at the time of inclusion without infection or exacerbation in the previous 4 weeks
  • Proficiency in using a smartphone

Exclusion criteria

  • Severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases, or requiring high-flow oxygen therapy (> 3-4 L/min)
  • History of exertional syncope or any comorbidity that prevents exercise training (such as severe orthopedic or neurological deficits or unstable heart disease)
  • Participation in a pulmonary rehabilitation program within the last 12 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Esra Pehli̇van — Istanbul

Identifiers

NCT: NCT06527612 · FILD_Progression

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗