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

Sponsor

Alexandria University (Other)

Overall Status

Completed

CT.gov ID

NCT05227443

Collaborator

(none)

Enrollment

Location

Arms

18.4

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Diseases Interstitial Lung Disease Fibrosis Lung	Procedure: Exercise aerobic training Procedure: Upper, lower and breathing (ULB) exercise	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The current study has 2 groups of patients subjected to 2 different modalities of aerobic exercise training and a control group.The current study has 2 groups of patients subjected to 2 different modalities of aerobic exercise training and a control group.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 16, 2020

Actual Primary Completion Date :

Apr 30, 2021

Actual Study Completion Date :

Jul 30, 2021

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Maximum oxygen consumption [6 weeks]
Cardiopulmonary exercise testing (CPET) was used to assess the improvement of maximum oxygen consumption.
Quality of life evaluation [6 weeks]
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.

Secondary Outcome Measures

Dyspnea [6 weeks]
mMRC dyspnea scale (ranging from 0 (the best) - 4 ( the worst) was used to evaluate the improvement of dyspnea.
Resting oxygen saturation [6 weeks]
Pulse oximeter was used to assess the change in oxygen saturation (SaO2) at rest after termination of exercise sessions. SaO2 is presented as percentage (%).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine, Alexandria University	Alexandria		Egypt	21526

Sponsors and Collaborators

Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanaa Shafiek, Assistant professor, Alexandria University

ClinicalTrials.gov Identifier:

NCT05227443

Other Study ID Numbers:

0201313

First Posted:

Feb 7, 2022

Last Update Posted:

Feb 23, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Diseases

Lung Diseases, Interstitial

Pulmonary Fibrosis

Study Results

No Results Posted as of Feb 23, 2022