Effects of Exercise Training on Respiratory Performance in Patients With Fibrosing Interstitial Lung Diseases (ET-fILD)

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Interstitial Lung Disease; Fibrosis Lung
• Intervention / Treatment: Procedure: Exercise aerobic training; Procedure: Upper, lower and breathing (ULB) exercise

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21526
    • Faculty of medicine, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The control group did not receive exercise training and the participants were informed to complete their medications provided by the treating physician.
Active Comparator: Lower limb (LL) exercise training; All the participants in this modality of training were subjected to only lower limbs aerobic exercise training.	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.; Other Names: Lower limbs (LL) training
Active Comparator: Upper, lower and breathing (ULB) exercise training; All the participants in this modality of training were subjected to upper and lower limb aerobic exercise training as well as breathing training.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum oxygen consumption	Cardiopulmonary exercise testing (CPET) was used to assess the improvement of maximum oxygen consumption.	6 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea	mMRC dyspnea scale (ranging from 0 (the best) - 4 ( the worst) was used to evaluate the improvement of dyspnea.	6 weeks
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

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 6, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Fibrosis; Lung Diseases, Interstitial
• Other Study ID Numbers: 0201313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We are planning to share IPD but until now we did not decided as we need to talk with all the researchers conducted the trial before it is available for the public. For the time being, the data is available on request from the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No