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

NCT06527612 | Recruiting

• 1 other identifier: FILD_Progression
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibrosis, Pulmonary; Pulmonary Rehabilitation

Keywords

ILD; fibrosis; exercise; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Six minute walking test

  Baseline, at 3rd, 6th and 12th months after the intervention

• Peripheral muscle strength

  Baseline, at 3rd, 6th and 12th months after the intervention

• Modified Medical Research Council Dyspnea Score

  Baseline, at 3rd, 6th and 12th months after the intervention

• Leicester cough questionnaire

  Baseline, at 3rd, 6th and 12th months after the intervention

Study Arms (2)

Exercise Group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Patients in the CGr will receive an information brochure containing medical treatment and physical activity recommendations.

Interventions

Pulmonary rehabilitation exercise programme OTHER

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.

Exercise Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Proficiency in using a smartphone

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Esra Pehli̇van

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Fibrosis; Fibrosis; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: July 29, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)