Effect of Selected Types of Breathing Exercises on Different Outcome Measures in Covid-19 Patients

March 2, 2023 updated by: Basma Mosaad Abd-elrahman Abushady
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 11595
        • Faculty of Physical Therapy Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bhastrika pranayama

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.
Other: 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
Other Names:
  • Bhastrika pranayama . Buteyko breathing exercise
Experimental: Buteyko breathing exercise

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.
Other: 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
Other Names:
  • Bhastrika pranayama . Buteyko breathing exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
week
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.
week
The Six-minute walk test:
Time Frame: week
The six-minute walk test (6MWT) will be done pre & post exercise program.
week
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
week
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
week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Basma Mosaad Abd-elrahman Abushady

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/004298

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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