Effects of Exercise Training on Respiratory Performance in Patients With Fibrosing Interstitial Lung Diseases (ET-fILD)
Primary Purpose
Lung Diseases, Interstitial Lung Disease, Fibrosis Lung
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Exercise aerobic training
Upper, lower and breathing (ULB) exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Diseases
Eligibility Criteria
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.
Sites / Locations
- Faculty of medicine, Alexandria University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Control
Lower limb (LL) exercise training
Upper, lower and breathing (ULB) exercise training
Arm Description
The control group did not receive exercise training and the participants were informed to complete their medications provided by the treating physician.
All the participants in this modality of training were subjected to only lower limbs aerobic 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.
Outcomes
Primary Outcome Measures
Maximum oxygen consumption
Cardiopulmonary exercise testing (CPET) was used to assess the improvement of maximum oxygen consumption.
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.
Secondary Outcome Measures
Dyspnea
mMRC dyspnea scale (ranging from 0 (the best) - 4 ( the worst) was used to evaluate the improvement of dyspnea.
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 (%).
Full Information
NCT ID
NCT05227443
First Posted
December 22, 2021
Last Updated
February 6, 2022
Sponsor
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT05227443
Brief Title
Effects of Exercise Training on Respiratory Performance in Patients With Fibrosing Interstitial Lung Diseases
Acronym
ET-fILD
Official Title
Effects of Different Exercise Training Programs on the Functional Performance in Fibrosing Interstitial Lung Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Interstitial Lung Disease, Fibrosis Lung
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group did not receive exercise training and the participants were informed to complete their medications provided by the treating physician.
Arm Title
Lower limb (LL) exercise training
Arm Type
Active Comparator
Arm Description
All the participants in this modality of training were subjected to only lower limbs aerobic exercise training.
Arm Title
Upper, lower and breathing (ULB) exercise training
Arm Type
Active Comparator
Arm Description
All the participants in this modality of training were subjected to upper and lower limb aerobic exercise training as well as breathing training.
Intervention Type
Procedure
Intervention Name(s)
Exercise aerobic training
Other Intervention Name(s)
Lower limbs (LL) training
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Upper, lower and breathing (ULB) exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum oxygen consumption
Description
Cardiopulmonary exercise testing (CPET) was used to assess the improvement of maximum oxygen consumption.
Time Frame
6 weeks
Title
Quality of life evaluation
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Dyspnea
Description
mMRC dyspnea scale (ranging from 0 (the best) - 4 ( the worst) was used to evaluate the improvement of dyspnea.
Time Frame
6 weeks
Title
Resting oxygen saturation
Description
Pulse oximeter was used to assess the change in oxygen saturation (SaO2) at rest after termination of exercise sessions. SaO2 is presented as percentage (%).
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of medicine, Alexandria University
City
Alexandria
ZIP/Postal Code
21526
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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.
Learn more about this trial
Effects of Exercise Training on Respiratory Performance in Patients With Fibrosing Interstitial Lung Diseases
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