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

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
breathing exercise
Sponsored by
Basma Mosaad Abd-elrahman Abushady
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

40 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physical Therapy Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bhastrika pranayama

Buteyko breathing exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
The Six-minute walk test:
The six-minute walk test (6MWT) will be done pre & post exercise program.
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
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

Secondary Outcome Measures

Full Information

First Posted
February 24, 2023
Last Updated
March 2, 2023
Sponsor
Basma Mosaad Abd-elrahman Abushady
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1. Study Identification

Unique Protocol Identification Number
NCT05753293
Brief Title
Effect of Selected Types of Breathing Exercises on Different Outcome Measures in Covid-19 Patients
Official Title
Effect of Selected Types of Breathing Exercises on Different Outcome Measures in Covid-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
July 22, 2022 (Actual)
Study Completion Date
September 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Basma Mosaad Abd-elrahman Abushady

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bhastrika pranayama
Arm Type
Experimental
Arm Description
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.
Arm Title
Buteyko breathing exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
breathing exercise
Other Intervention Name(s)
Bhastrika pranayama . Buteyko breathing exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Modified Borg Scale to Measure dyspnea:
Description
is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient with higher score indicates breathing problem.
Time Frame
week
Title
Blood Samples:
Description
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.
Time Frame
week
Title
The Six-minute walk test:
Description
The six-minute walk test (6MWT) will be done pre & post exercise program.
Time Frame
week
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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
Time Frame
week
Title
The 36-Item Short-Form Health Survey (SF-36) Questionnaire
Description
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
Time Frame
week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Giza
ZIP/Postal Code
11595
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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