An interventional study of Pulmonary rehabilitation exercise programme in Fibrosis, Pulmonary and Pulmonary Rehabilitation, sponsored by Istanbul Medipol University Hospital. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-12.
Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment
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.
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
680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.
This study's planned enrollment of 56 is above the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.
Browse Pulmonary Fibrosis studies →Istanbul Medipol University Hospital is the lead sponsor of 350 studies on the registry; 58 are open to participants now.
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Exclusion Criteria:
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.
Other: Pulmonary rehabilitation exercise programme
Patients in the CGr will receive an information brochure containing medical treatment and physical activity recommendations.
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.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, at 3rd, 6th and 12th months after the intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, at 3rd, 6th and 12th months after the intervention
Plan to share: No
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Istanbul Medipol University Hospital