COVID-19NCT05382780
Breather Trainer Versus Pulmonary Rehabilitation on Cardiopulmonary Efficiency
A study testing The breather respiratory muscle trainer, Diaphragmatic and localized breathing exercises and interval aerobic training and respiratory training in people with COVID-19 and COPD, run by Horus University at 1 site in Egypt.
Trial summary
The purpose of the study is to determine the difference between The Breather respiratory muscle trainer and pulmonary rehabilitation in patients with COPD post COVID-19. Read more about this study
- Who is it for?
- Ages 30 to 40 yearsHealthy volunteers can take part
- What is being tested?
- The breather respiratory muscle trainer, Diaphragmatic and localized breathing exercises and interval aerobic training and respiratory training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 15 Nov 2022
- 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 30 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- SPO2 ≥ 93%
- Their age ranges from 30-40 years old.
- COPD patients GOLD1 (Mild FEV1≥80% predicted) and GOLD2 (Moderate 50% ≤FEV1<80%predicted) (Manian, 2019)
- patients diagnosed as post COVID-19 Pneumonia between 3 and 6 Months ago with CT scan and PCR testing.
- Their body mass index (BMI) ranged from 20 to 29.9kg/m2.
- Stable medical cases with dyspnea
Who cannot join
- Patients who will meet one of the following criteria will be excluded from the study:
- patients with cardiac problems e.g. atrial fibrillation, left bundle-branch block, heart failure.
- Sever cases of COPD (FEV1/FVC< 50%)
- Mitral or aortic valvular disease, pericardial effusion.
- Recent myocardial infarction.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt
Damietta
About this study
Official title: Effect of Breather Trainer Versus Pulmonary Rehabilitation on Cardiopulmonary Efficiency in Patients With COPD Post COVID-19
The purpose of the study is to determine the difference between The Breather respiratory muscle trainer and pulmonary rehabilitation in patients with COPD post COVID-19.
Read the detailed description
The main concern in post COVID-19 patients is the involvement of respiratory system and cardiovascular system which may result in dyspnea, low blood oxygen saturation, and decrease cardiopulmonary efficiency.
In cases of post COVID-19 patients with COPD their state is deconditioned and more critical than normal to be either in the zone of progression or regression or stability as the studies showed that handling of these cases during (3-6 months post-COVID) will prevent these symptoms from becoming permanent.
- Being tested
- The breather respiratory muscle trainer, Diaphragmatic and localized breathing exercises, interval aerobic training and respiratory training
- Medical subject headings
- COVID-19, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The breather respiratory muscle trainerOther
The breather respiratory muscle training device is a high quality and effective trainer designed to specifically train the inspiratory and expiratory muscles in one same breathing action. The device allows for adjustable levels of resistance using easy-to-read dials, which allows you to adjust the device to the settings you require. The inhale settings allow for adjustment 1-6 with 1 being the easiest and 6 being the hardest, while the exhale settings allow for adjustment 1-5, where 1 in the easiest and 5 the hardest.
Diaphragmatic and localized breathing exercisesOther
- Diaphragmatic breathing exercises:
Exercise will be performed as prescribed in the clinical guidelines for 5-10 minutes about 3-4 times per day.
- Localized Breathing:
Exercise will be performed as prescribed in the clinical guidelines for 5-10 minutes about 3-4 times per day.
- Mild Interval training exercise
interval aerobic training and respiratory trainingOther
mild intensity interval aerobic training and respiratory training on treadmill
| Study group | Role | What they receive |
|---|---|---|
| The breather respiratory muscle trainer group | Experimental | 40 patients (20 males and 20 females) will receive The breather respiratory muscle trainer for 30 minutes and mild interval aerobic training and respiratory training on treadmill 3 times / week for 12 weeks. Receives: Other: The breather respiratory muscle trainer; Other: interval aerobic training and respiratory training |
| Diaphragmatic and localized breathing exercises group | Experimental | 40 patients (20 males and 20 females) will receive diaphragmatic and localized breathing exercises ( especially Middle \& Lower segments) and mild intensity interval aerobic training and respiratory training on treadmill 3 times / week for 12 weeks, Receives: Other: Diaphragmatic and localized breathing exercises; Other: interval aerobic training and respiratory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change in Physical Fitness Index (PFI)
To assess the change in Physical Fitness Index (PFI) By using Modified Harvard Step Test (HST): The test will be done on a step height of 33 cm height. PFI was calculated by using following formula
Measured: at baseline and 3 months of intervention
Assessment of change in Rate Pressure Product
To assess the change in Rate Pressure Product. First, the baseline heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be recorded, by an aneroid sphygmomanometer. HR will be constantly displayed on pulse oximetry.
The rate-pressure product (RPP) = HR X SBP
Measured: at baseline and 3 months of intervention
Assessment of change in Forced vital capacity
To assess the change in Forced vital capacity (FVC) by spirometry. The unit of measure is liters.
Measured: at baseline and 3 months of intervention
Assessment of change in Forced expiratory volume in the first one second
To assess the change in Forced expiratory volume in the first one second (FEV1) by spirometry. The unit of measure is liters.
Measured: at baseline and 3 months of intervention
Assessment of change in Ratio of forced expiratory volume in the first one second to the forced vital capacity of lungs
To assess the change in the ratio of forced expiratory volume in the first one second to the forced vital capacity of lungs (FEV1/FVC) by spirometry. The unit of measure is the ratio.
Measured: at baseline and 3 months of intervention
Assessment of change in Maximum voluntry ventilation
To assess the change in the maximum voluntary ventilation (MVV) by spirometry. The unit of measure is the liters/ minute.
Measured: at baseline and 3 months of intervention
Assessment of change in Forced vital capacity expressed as percentage of the predicted FVC
To assess the change in the Forced vital capacity expressed as a percentage of the predicted FVC (FVC%) by spirometry. The unit of measure is the liters.
Measured: at baseline and 3 months of intervention
Assessment of change in Forced expiratory volume in the first one second expressed as percentage of the predicted FEV1
To assess the change in the Forced expiratory volume in the first one second expressed as a percentage of the predicted FEV1 (FEV1%) by spirometry. The unit of measure is the liters.
Measured: at baseline and 3 months of intervention
Secondary outcomes (1)
Assessment of change in Oxygen saturation
To assess the change in the Oxygen saturation using pulse oximeter device.
Measured: at baseline and 3 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Rashad Ali Elsayed, Horus University
- Investigators
- Eman Rashad, Assistant lecturer, Principal investigator, Horus University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382780
- Sponsor's protocol ID
- Eman_Rashad_PhD_2022
- Status last verified
- May 2022
- First submitted
- 24 Apr 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breather Trainer Versus Pulmonary Rehabilitation on Cardiopulmonary Efficiency in Patients With COPD Post COVID-19
- ClinicalTrials.gov ID
- NCT05382780
- Acronym / sponsor ID
- Eman_Rashad_PhD_2022
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 19 May 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 purpose of the study is to determine the difference between The Breather respiratory muscle trainer and pulmonary rehabilitation in patients with COPD post COVID-19.
Detailed description
The main concern in post COVID-19 patients is the involvement of respiratory system and cardiovascular system which may result in dyspnea, low blood oxygen saturation, and decrease cardiopulmonary efficiency.
In cases of post COVID-19 patients with COPD their state is deconditioned and more critical than normal to be either in the zone of progression or regression or stability as the studies showed that handling of these cases during (3-6 months post-COVID) will prevent these symptoms from becoming permanent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The breather respiratory muscle trainer group | Experimental | Other: The breather respiratory muscle trainer, Other: interval aerobic training and respiratory training40 patients (20 males and 20 females) will receive The breather respiratory muscle trainer for 30 minutes and mild interval aerobic training and respiratory training on treadmill 3 times / week for 12 weeks. |
| Diaphragmatic and localized breathing exercises group | Experimental | Other: Diaphragmatic and localized breathing exercises, Other: interval aerobic training and respiratory training40 patients (20 males and 20 females) will receive diaphragmatic and localized breathing exercises ( especially Middle \& Lower segments) and mild intensity interval aerobic training and respiratory training on treadmill 3 times / week for 12 weeks, |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- SPO2 ≥ 93%
- Their age ranges from 30-40 years old.
- COPD patients GOLD1 (Mild FEV1≥80% predicted) and GOLD2 (Moderate 50% ≤FEV1<80%predicted) (Manian, 2019)
- patients diagnosed as post COVID-19 Pneumonia between 3 and 6 Months ago with CT scan and PCR testing.
- Their body mass index (BMI) ranged from 20 to 29.9kg/m2.
Key exclusion criteria (5 listed)
- patients with cardiac problems e.g. atrial fibrillation, left bundle-branch block, heart failure.
- Sever cases of COPD (FEV1/FVC< 50%)
- Mitral or aortic valvular disease, pericardial effusion.
- Recent myocardial infarction.
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 |
|---|---|---|
| The breather respiratory muscle trainerThe breather respiratory muscle training device is a high quality and effective trainer designed to specifically train the inspiratory and expiratory muscles in one same breathing action. The device allows for adjustable levels of resistance using easy-to-read dials, which allows you to adjust the device to the settings you require. The inhale settings allow for adjustment 1-6 with 1 being the easiest and 6 being the hardest, while the exhale settings allow for adjustment 1-5, where 1 in the easiest and 5 the hardest. | Other | The breather respiratory muscle trainer group |
| Diaphragmatic and localized breathing exercisesA. Diaphragmatic breathing exercises: Exercise will be performed as prescribed in the clinical guidelines for 5-10 minutes about 3-4 times per day. B. Localized Breathing: Exercise will be performed as prescribed in the clinical guidelines for 5-10 minutes about 3-4 times per day. C. Mild Interval training exercise | Other | Diaphragmatic and localized breathing exercises group |
| interval aerobic training and respiratory trainingmild intensity interval aerobic training and respiratory training on treadmill | Other | Diaphragmatic and localized breathing exercises group, The breather respiratory muscle trainer group |
Primary outcome
Assessment of change in Physical Fitness Index (PFI)
Time frame: at baseline and 3 months of intervention
To assess the change in Physical Fitness Index (PFI) By using Modified Harvard Step Test (HST): The test will be done on a step height of 33 cm height. PFI was calculated by using following formula
Assessment of change in Rate Pressure Product
Time frame: at baseline and 3 months of intervention
To assess the change in Rate Pressure Product. First, the baseline heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be recorded, by an aneroid sphygmomanometer. HR will be constantly displayed on pulse oximetry. The rate-pressure product (RPP) = HR X SBP
Assessment of change in Forced vital capacity
Time frame: at baseline and 3 months of intervention
To assess the change in Forced vital capacity (FVC) by spirometry. The unit of measure is liters.
Assessment of change in Forced expiratory volume in the first one second
Time frame: at baseline and 3 months of intervention
To assess the change in Forced expiratory volume in the first one second (FEV1) by spirometry. The unit of measure is liters.
Assessment of change in Ratio of forced expiratory volume in the first one second to the forced vital capacity of lungs
Time frame: at baseline and 3 months of intervention
To assess the change in the ratio of forced expiratory volume in the first one second to the forced vital capacity of lungs (FEV1/FVC) by spirometry. The unit of measure is the ratio.
Assessment of change in Maximum voluntry ventilation
Time frame: at baseline and 3 months of intervention
To assess the change in the maximum voluntary ventilation (MVV) by spirometry. The unit of measure is the liters/ minute.
Assessment of change in Forced vital capacity expressed as percentage of the predicted FVC
Time frame: at baseline and 3 months of intervention
To assess the change in the Forced vital capacity expressed as a percentage of the predicted FVC (FVC%) by spirometry. The unit of measure is the liters.
Assessment of change in Forced expiratory volume in the first one second expressed as percentage of the predicted FEV1
Time frame: at baseline and 3 months of intervention
To assess the change in the Forced expiratory volume in the first one second expressed as a percentage of the predicted FEV1 (FEV1%) by spirometry. The unit of measure is the liters.
1 secondary outcome
Assessment of change in Oxygen saturation
Time frame: at baseline and 3 months of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Eman Rashad, Assistant lecturer principal investigator
Horus University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The breather respiratory muscle trainer, Diaphragmatic and localized breathing exercises and interval aerobic training and respiratory training in people with COVID-19 and COPD, run by Horus 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Rashad, Assistant lecturer (+201011431165, eali@horus.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of change in Physical Fitness Index (PFI) (time frame: at baseline and 3 months of intervention). The study lists 8 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 19 May 2022.