The Effect of Exercise Training on Quality of Life and Disease Progression in Fibrosing Interstitial Lung Patients
NCT Number: NCT06527612
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fibrosis, Pulmonary|Pulmonary Rehabilitation
Interventions: OTHER: Pulmonary rehabilitation exercise programme
Sponsor: Istanbul Medipol University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-29
Completion Date: 2026-08-01
Locations: Esra Pehli̇van, İstanbul, Üsküdar, 34668, Turkey

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.

Primary Outcome Measures: Saint George Quality of life questionnaire, Saint George Respiratory Questionaire (SGRQ) score: The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)., Baseline, at 3rd, 6th and 12th months after the intervention|Forced vital capacity, It will perform by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines., Baseline, at 3rd, 6th and 12th months after the intervention|Diffusing Capacity of the Lungs for Carbon Monoxide, Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) measurement will be conducted as part of the study to assess the lung function of participants. This test evaluates how well gases such as oxygen are transferred from the lungs to the blood., Baseline, at 3rd, 6th and 12th months after the intervention|Peripheral oxygen saturation, Peripheral oxygen saturation (SpO2) will be measured to assess the oxygen level in the blood. This non-invasive test provides an indication of how well oxygen is being transported to the extremities of the body, which is essential for evaluating respiratory function., Baseline, at 3rd, 6th and 12th months after the intervention
Secondary Outcome Measures: Six minute walking test, The 6-minute walking test will conduct in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Participants will ask to walk as far as they can. Prior to and following the test, oxygen saturation, heart rate and Borg fatigue rating will measure, and the walking distance will record., Baseline, at 3rd, 6th and 12th months after the intervention|Peripheral muscle strength, Peripheral muscle strength will be assessed using a digital dynamometer. This device measures the maximum force exerted by muscles in various extremities, providing quantitative data on muscle strength. The measurements will help evaluate the participants' muscle function and overall physical condition., Baseline, at 3rd, 6th and 12th months after the intervention|Modified Medical Research Council Dyspnea Score, Modified Medical Council Dyspnea score will rate the sensation of dyspnea as the person perceives it.The severity of dyspnea is rated on a scale of 0 to 4."0 point" means no dyspnea perception and "4point" means severe dyspnea perception., Baseline, at 3rd, 6th and 12th months after the intervention|Leicester cough questionnaire, The Leicester Cough Questionnaire (LCQ) consists of 19 items divided into three domains: physical, psychological, and social. Each item is scored on a 7-point Likert scale, where 1 indicates the greatest impairment and 7 indicates no impairment. The scores from each domain are summed to provide a total score, with higher scores indicating a better quality of life and fewer symptoms related to chronic cough. The maximum total score is 21, reflecting the best possible quality of life., Baseline, at 3rd, 6th and 12th months after the intervention