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

August 8, 2024 updated by: esra pehlivan, Istanbul Medipol University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Group
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
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.
No Intervention: Control group
Patients in the CGr will receive an information brochure containing medical treatment and physical activity recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Saint George Quality of life questionnaire
Time Frame: Baseline, at 3rd, 6th and 12th months after the intervention
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
Time Frame: Baseline, at 3rd, 6th and 12th months after the intervention
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
Time Frame: Baseline, at 3rd, 6th and 12th months after the intervention
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
Time Frame: Baseline, at 3rd, 6th and 12th months after the intervention
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

Outcome Measure
Measure Description
Time Frame
Six minute walking test
Time Frame: Baseline, at 3rd, 6th and 12th months after the intervention
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
Modified Medical Research Council Dyspnea Score
Time Frame: Baseline, at 3rd, 6th and 12th months after the intervention
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
Time Frame: Baseline, at 3rd, 6th and 12th months after the intervention
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
Peripheral muscle strength
Time Frame: Baseline, at 3rd, 6th and 12th months after the intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FILD_Progression

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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