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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lung Diseases, Interstitial Lung Disease, Fibrosis Lung

Intervention / Treatment
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* Procedure: Exercise aerobic training
* Procedure: Upper, lower and breathing (ULB) exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>All the participants in this modality of training were subjected to only lower limbs aerobic exercise training. | Procedure: Exercise aerobic training<br>* 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.<br>* Other names: Lower limbs (LL) training;|
| Active Comparator: Upper, lower and breathing (ULB) exercise training<br>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<br>* 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.<br>|

What is the study measuring?
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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 |