Lung DiseasesET-fILDNCT05227443
Effects of Exercise Training on Respiratory Performance in Patients With Fibrosing Interstitial Lung Diseases
A study testing Exercise aerobic training and Upper, lower and breathing (ULB) exercise in people with Lung Diseases and Interstitial Lung Disease, run by Alexandria University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Interstitial Lung Disease, Fibrosis Lung
- What is being tested?
- Exercise aerobic training and Upper, lower and breathing (ULB) exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jan 2020to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Diseases, Interstitial Lung Disease, Fibrosis Lung
- Being tested
- Exercise aerobic training, Upper, lower and breathing (ULB) exercise
- Medical subject headings
- Lung Diseases, Lung Diseases, Interstitial, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise aerobic trainingProcedure or surgery
Also called Lower limbs (LL) 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) exerciseProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group did not receive exercise training and the participants were informed to complete their medications provided by the treating physician. |
| Lower limb (LL) exercise training | Active comparator | All the participants in this modality of training were subjected to only lower limbs aerobic exercise training. Receives: Procedure: Exercise aerobic training |
| Upper, lower and breathing (ULB) exercise training | Active comparator | All the participants in this modality of training were subjected to upper and lower limb aerobic exercise training as well as breathing training. Receives: Procedure: Upper, lower and breathing (ULB) exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum oxygen consumption
Cardiopulmonary exercise testing (CPET) was used to assess the improvement of maximum oxygen consumption.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (2)
Dyspnea
mMRC dyspnea scale (ranging from 0 (the best) - 4 ( the worst) was used to evaluate the improvement of dyspnea.
Measured: 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 (%).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start16 Jan 2020
- Primary completion30 Apr 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa Shafiek, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227443
- Sponsor's protocol ID
- 0201313
- Acronym
- ET-fILD
- Status last verified
- Feb 2022
- First submitted
- 22 Dec 2021
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Exercise Training Programs on the Functional Performance in Fibrosing Interstitial Lung Diseases
- ClinicalTrials.gov ID
- NCT05227443
- Acronym / sponsor ID
- ET-fILD / 0201313
- Conditions
- Lung Diseases, Interstitial Lung Disease, Fibrosis Lung
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The current study has 2 groups of patients subjected to 2 different modalities of aerobic exercise training and a control group.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group did not receive exercise training and the participants were informed to complete their medications provided by the treating physician. |
| Lower limb (LL) exercise training | Active comparator | Procedure: Exercise aerobic trainingAll the participants in this modality of training were subjected to only lower limbs aerobic exercise training. |
| Upper, lower and breathing (ULB) exercise training | Active comparator | Procedure: Upper, lower and breathing (ULB) exerciseAll the participants in this modality of training were subjected to upper and lower limb aerobic exercise training as well as breathing training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Motor disabilities
- Cardiovascular diseases (as acute heart failure, unstable angina or recent myocardial infarction)
- Cognitive impairments
- History of cerebrovascular accident
- Active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise aerobic trainingAlso: Lower limbs (LL) trainingIt 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. | Procedure or surgery | Lower limb (LL) exercise training |
| Upper, lower and breathing (ULB) exerciseIt 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. | Procedure or surgery | Upper, lower and breathing (ULB) exercise training |
Primary outcome
Maximum oxygen consumption
Time frame: 6 weeks
Cardiopulmonary exercise testing (CPET) was used to assess the improvement of maximum oxygen consumption.
Quality of life evaluation
Time frame: 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.
2 secondary outcomes
Dyspnea
Time frame: 6 weeks
Resting oxygen saturation
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise aerobic training and Upper, lower and breathing (ULB) exercise in people with Lung Diseases and Interstitial Lung Disease, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum oxygen consumption (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.