Clinical trial NCT06527612: The Effect of Exercise Training on Quality of Life and Disease Progression in Fibrosing Interstitial Lung Patients
Official title: The Effect of Exercise Training on Quality of Life and Disease Progression in Fibrosing Interstitial Lung Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibrosis, Pulmonary
Pulmonary Rehabilitation
Keywords: ILD
fibrosis
exercise
pulmonary rehabilitation
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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

Primary outcomes:
measure: Saint George Quality of life questionnaire
timeFrame: Baseline, at 3rd, 6th and 12th months after the intervention
measure: Forced vital capacity
timeFrame: Baseline, at 3rd, 6th and 12th months after the intervention
measure: Diffusing Capacity of the Lungs for Carbon Monoxide
timeFrame: Baseline, at 3rd, 6th and 12th months after the intervention
measure: Peripheral oxygen saturation
timeFrame: Baseline, at 3rd, 6th and 12th months after the intervention
Secondary outcomes:
measure: Six minute walking test
timeFrame: Baseline, at 3rd, 6th and 12th months after the intervention
measure: Peripheral muscle strength
timeFrame: Baseline, at 3rd, 6th and 12th months after the intervention
measure: Modified Medical Research Council Dyspnea Score
timeFrame: Baseline, at 3rd, 6th and 12th months after the intervention
measure: Leicester cough questionnaire
timeFrame: Baseline, at 3rd, 6th and 12th months after the intervention
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Esra Pehli̇van
state: Üsküdar
Study officials:
References: