Effects of Exercise Training on Respiratory Performance in Patients With Fibrosing Interstitial Lung Diseases

Lung Diseases Clinical Trial

— ET-fILD  

Official title:

Effects of Different Exercise Training Programs on the Functional Performance in Fibrosing Interstitial Lung Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05227443
• Other study ID #: 0201313
• Status: Completed
• Phase: N/A
• Start date: January 16, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: February 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study recruited patients with fibrosing interstitial lung diseases (f-ILD) whatever was the underlying pathology. The investigators aimed to compare the effects of aerobic exercises for lower limbs (LL) versus upper limbs, lower limbs, and breathing exercises (ULB) on the peak exercise measurements that was measured using cardiopulmonary exercise testing (CPET), dyspnea and health related quality of life assessment in this group of patients.

Description:

The investigators conducted a case-control study with a follow up after 6 weeks (short term). All the participants on recruited were evaluated clinically. A high resolution computed tomography (HRCT) scan of the chest was performed to confirm the diagnosis of f-ILD as well as a spirometry. All the patients were subjected to cardiopulmonary exercise testing (CPET), 6-minute walk test (6-MWT), evaluation of dyspnea using mMRC dyspnea scale, and evaluation of health related quality of life using St. George's Respiratory Questionnaire (SGRQ). The control group were followed up by telephone calls. The intervention groups (LL and ULB) were subjected randomly to aerobic exercise training for 6 weeks. After termination of all the session, the patients were re-evaluated clinically and objectively using CPET, 6-MWT, mMRC and SGRQ. Also, we evaluated the outcome of the patients (control and intervention groups) as those who died or reported exacerbation of the underlying disease were recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients aged = 18 years.

• Fibrosis interstitial lung diseases (f-ILDs) diagnosed based on HRCT radiological features.

• Restrictive or mixed pattern in forced spirometry test

Exclusion Criteria:

• Motor disabilities

• Cardiovascular diseases (as acute heart failure, unstable angina or recent myocardial infarction)

• Cognitive impairments

• History of cerebrovascular accident

• Active cancer

• Life expectancy less than 3 months.

Related Conditions & MeSH terms

• Fibrosis Lung
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Fibrosis

Intervention

Procedure:
• Exercise aerobic training
It is a procedure that is in the form of exercise training as a part of rehabilitation. The patients were subjected to 3 supervised sessions of exercise training / week for a total duration of 6 weeks. The form of training was aerobic intensity exercise that lasts for 15 minutes of continuous exercise. In this intervention, the investigators provide only lower limbs training exercises.
• Upper, lower and breathing (ULB) exercise
It is a procedure that is in the form of exercise training as a part of rehabilitation. The patients were subjected to 3 supervised sessions of exercise training / week for a total duration of 6 weeks. The form of training was aerobic intensity exercise that lasts for 15 minutes of continuous exercise. In this intervention, the investigators provide lower and upper limbs training exercises as well as breathing exercises.

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum oxygen consumption	Cardiopulmonary exercise testing (CPET) was used to assess the improvement of maximum oxygen consumption.	6 weeks
Primary	Quality of life evaluation	St. George's Respiratory Questionnaire (SGRQ) was used to assess the health related quality of life. SGRS constitutes 50 items and the score ranging from 0 to 100, with higher scores indicating more limitations.	6 weeks
Secondary	Dyspnea	mMRC dyspnea scale (ranging from 0 (the best) - 4 ( the worst) was used to evaluate the improvement of dyspnea.	6 weeks
Secondary	Resting oxygen saturation	Pulse oximeter was used to assess the change in oxygen saturation (SaO2) at rest after termination of exercise sessions. SaO2 is presented as percentage (%).	6 weeks