COVID-19NCT05753293
Effect of Selected Types of Breathing Exercises on Different Outcome Measures in Covid-19 Patients
A study testing breathing exercise in people with COVID-19, run by Basma Mosaad Abd-elrahman Abushady at 1 site in Egypt.
Trial summary
Coronavirus disease 2019 (COVID-19) infection leads to significant respiratory that have negative impact on function and quality of life (QoL). Breathing exercises are effective and important in patients with COVID-19. Read more about this study
- Who is it for?
- Ages 40 to 50 years
- Conditions the study is for
- COVID-19
- What is being tested?
- breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 25 Sep 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 40 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Their age ranged from 40 to 50years old.
- with confirmed COVID-19 by positive nasopharyngeal swab samples and presence of ground-glass opacification in their chest computed tomography scan (CT-scan).
- Moderate hospitalized covid-19 patient.
- full consciousness and oriented.
- BMI 20-25 kg/m2.
Who cannot join
- presence of any type of musculoskeletal disorder prohibits the patient from participating in the study
- history of chronic diseases as (diabetes, hypertension and heart diseases)
- Any type of obvious clinically mental or cognitive impairment.
- History of previous other respiratory disease.
Trial locations and contacts
1 site in 1 country.
About this study
Coronavirus disease 2019 (COVID-19) infection leads to significant respiratory that have negative impact on function and quality of life (QoL). Breathing exercises are effective and important in patients with COVID-19.
Read the detailed description
Coronavirus disease 2019 (COVID-19) infection leads to significant respiratory symptoms that have negative impact on function and quality of life (QoL). Breathing exercises are effective and important in patients with COVID-19.
This study aimed to evaluate the effect of Buteyko breathing versus Bhastrika Pranayama on different outcome measures in COVID-19 Patients.
Sixty patients of both genders with age range from 40-50 years old were recruited from El Khankah Centeral Hospital with positive nasopharyngeal swab samples and presence of ground-glass opacification in their chest computed tomography scan (CT-scan). Patients were assigned randomly into two groups A \& B and took their medications. Group A received traditional physical therapy program (mobility exercises and Postural drainage) with Bhastrika Pranayama breathing exercise. Group B received traditional physical therapy program with Buteyko breathing exercise. Patients were assessed by Modified Borg Dyspnea Scale (MBS), blood samples (levels of CRP and d-dimer), six-minute walk test (6MWT), Pittsburgh Sleep Quality Index (PSQI), 36-Item Short-Form Health Survey (SF-36) Questionnaire.
- Conditions
- COVID-19
- Being tested
- breathing exercise
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breathing exerciseOther
Also called Bhastrika pranayama . Buteyko breathing exercise
Buteyko breathing technique developed to control hyperventilation and anxiety which leads to shortness of breath. It uses series of exercises to teach patients to breathe less deeply and less rapidly /Bhastrika "Bellow Breathing" is diaphragmatic breathing - deep breathing involving the diaphragm rather than the accessory muscles. Regulated pranayama exercises require inhalation, maintaining isometric contraction of respiratory muscles and forceful expiration. These techniques will strengthen respiratory muscles
| Study group | Role | What they receive |
|---|---|---|
| Bhastrika pranayama | Experimental | done in sitting posture and the following instructions: The back must be kept straight and shoulder muscles should be kept relaxed, patient was asked to close the right nostril with right thumb and to bring right elbow to the level of right shoulder.
To close the eyes, inhale and exhale through left nostril-first slowly, then a little faster, The subject was asked to do the above steps about 20-25 times, (Then the subject was asked to take a long breath in and retain it for as long as possible, This is one cycle of Bhastrika pranayama. The subject has to repeat this cycle by closing left nostril and breathing through right nostril. Receives: Other: breathing exercise |
| Buteyko breathing exercise | Experimental | Step 1 beginning control pause (CP) the patient inhales and then exhales through the nose and then holds their breath until the point they feel either the first clear and distinct desire to breath or involuntary movement or jerk coming from diaphragm.Step 2 three to five minutes of relaxed reduced-volume breathing or slow breathing the patient gradually reduced their breathing until they feel a light lack of air. they sustain these while staying relaxed.
Step 3 maximum pause (MP) the maximum pause begins with gentel inhalation and exhalation. Then the breath is held as long as possible but not to the point of severe discomfort.
Step 2 and step 3 are then repeated up to 5 times. Final control pause: same as step 1. Receives: Other: breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Borg Scale to Measure dyspnea:
is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient with higher score indicates breathing problem.
Measured: week
Blood Samples:
The blood samples will be collected before starting and at the end of the study to measure levels of CRP, d-dimer and CBC to test.
Measured: week
The Six-minute walk test:
The six-minute walk test (6MWT) will be done pre \& post exercise program.
Measured: week
Pittsburgh Sleep Quality Index (PSQI)
The PSQI questionnaire was used to measure sleep quality using an 18-item scale containing seven items that included sleep quality, sleep duration, sleep latency, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction. Each dimension scored between 0-3, with a total score ranging from 0-21, and a higher score indicating lower sleep quality
Measured: week
The 36-Item Short-Form Health Survey (SF-36) Questionnaire
The SF-36 is a 36-item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items) the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability
Measured: week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start1 May 2022
- Primary completion22 Jul 2022
- Study completion25 Sep 2022
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sixty patients of both genders with age range from 40-50 years old will be recruited from El Khankah Centeral Hospital with positive nasopharyngeal swab samples and presence of ground-glass opacification in their chest computed tomography scan (CT-scan) will be assigned randomly into two groups A \& B and take their medications.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basma Mosaad Abd-elrahman Abushady
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Basma Mosaad Abd-elrahman Abushady, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753293
- Sponsor's protocol ID
- P.T.REC/012/004298
- Status last verified
- Feb 2023
- First submitted
- 24 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Selected Types of Breathing Exercises on Different Outcome Measures in Covid-19 Patients
- ClinicalTrials.gov ID
- NCT05753293
- Acronym / sponsor ID
- P.T.REC/012/004298
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Basma Mosaad Abd-elrahman AbushadyUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 25 Sep 2022 (actual)
- First posted
- 3 Mar 2023 (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.
Coronavirus disease 2019 (COVID-19) infection leads to significant respiratory that have negative impact on function and quality of life (QoL). Breathing exercises are effective and important in patients with COVID-19.
Detailed description
Coronavirus disease 2019 (COVID-19) infection leads to significant respiratory symptoms that have negative impact on function and quality of life (QoL). Breathing exercises are effective and important in patients with COVID-19.
This study aimed to evaluate the effect of Buteyko breathing versus Bhastrika Pranayama on different outcome measures in COVID-19 Patients.
Sixty patients of both genders with age range from 40-50 years old were recruited from El Khankah Centeral Hospital with positive nasopharyngeal swab samples and presence of ground-glass opacification in their chest computed tomography scan (CT-scan). Patients were assigned randomly into two groups A \& B and took their medications. Group A received traditional physical therapy program (mobility exercises and Postural drainage) with Bhastrika Pranayama breathing exercise. Group B received traditional physical therapy program with Buteyko breathing exercise. Patients were assessed by Modified Borg Dyspnea Scale (MBS), blood samples (levels of CRP and d-dimer), six-minute walk test (6MWT), Pittsburgh Sleep Quality Index (PSQI), 36-Item Short-Form Health Survey (SF-36) Questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sixty patients of both genders with age range from 40-50 years old will be recruited from El Khankah Centeral Hospital with positive nasopharyngeal swab samples and presence of ground-glass opacification in their chest computed tomography scan (CT-scan) will be assigned randomly into two groups A \& B and take their medications.
| Arm | Type | Receives |
|---|---|---|
| Bhastrika pranayama | Experimental | Other: breathing exercisedone in sitting posture and the following instructions: The back must be kept straight and shoulder muscles should be kept relaxed, patient was asked to close the right nostril with right thumb and to bring right elbow to the level of right shoulder. To close the eyes, inhale and exhale through left nostril-first slowly, then a little faster, The subject was asked to do the above steps about 20-25 times, (Then the subject was asked to take a long breath in and retain it for as long as possible, This is one cycle of Bhastrika pranayama. The subject has to repeat this cycle by closing left nostril and breathing through right nostril. |
| Buteyko breathing exercise | Experimental | Other: breathing exerciseStep 1 beginning control pause (CP) the patient inhales and then exhales through the nose and then holds their breath until the point they feel either the first clear and distinct desire to breath or involuntary movement or jerk coming from diaphragm.Step 2 three to five minutes of relaxed reduced-volume breathing or slow breathing the patient gradually reduced their breathing until they feel a light lack of air. they sustain these while staying relaxed. Step 3 maximum pause (MP) the maximum pause begins with gentel inhalation and exhalation. Then the breath is held as long as possible but not to the point of severe discomfort. Step 2 and step 3 are then repeated up to 5 times. Final control pause: same as step 1. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Their age ranged from 40 to 50years old.
- with confirmed COVID-19 by positive nasopharyngeal swab samples and presence of ground-glass opacification in their chest computed tomography scan (CT-scan).
- Moderate hospitalized covid-19 patient.
- full consciousness and oriented.
- BMI 20-25 kg/m2.
Key exclusion criteria (4 listed)
- presence of any type of musculoskeletal disorder prohibits the patient from participating in the study
- history of chronic diseases as (diabetes, hypertension and heart diseases)
- Any type of obvious clinically mental or cognitive impairment.
- History of previous other respiratory disease.
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 |
|---|---|---|
| breathing exerciseAlso: Bhastrika pranayama . Buteyko breathing exerciseButeyko breathing technique developed to control hyperventilation and anxiety which leads to shortness of breath. It uses series of exercises to teach patients to breathe less deeply and less rapidly /Bhastrika "Bellow Breathing" is diaphragmatic breathing - deep breathing involving the diaphragm rather than the accessory muscles. Regulated pranayama exercises require inhalation, maintaining isometric contraction of respiratory muscles and forceful expiration. These techniques will strengthen respiratory muscles | Other | Bhastrika pranayama, Buteyko breathing exercise |
Primary outcome
Modified Borg Scale to Measure dyspnea:
Time frame: week
is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient with higher score indicates breathing problem.
Blood Samples:
Time frame: week
The blood samples will be collected before starting and at the end of the study to measure levels of CRP, d-dimer and CBC to test.
The Six-minute walk test:
Time frame: week
The six-minute walk test (6MWT) will be done pre \& post exercise program.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: week
The PSQI questionnaire was used to measure sleep quality using an 18-item scale containing seven items that included sleep quality, sleep duration, sleep latency, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction. Each dimension scored between 0-3, with a total score ranging from 0-21, and a higher score indicating lower sleep quality
The 36-Item Short-Form Health Survey (SF-36) Questionnaire
Time frame: week
The SF-36 is a 36-item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items) the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability
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 3 Mar 2023.
- Individual participant dataSharing planned: No
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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 breathing exercise in people with COVID-19, run by Basma Mosaad Abd-elrahman Abushady 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 5 inclusion and 4 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 3 Mar 2023. 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?
Modified Borg Scale to Measure dyspnea: (time frame: week). The study lists 5 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 3 Mar 2023.