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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05753293
Other study ID # P.T.REC/012/004298
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date September 25, 2022

Study information

Verified date February 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 25, 2022
Est. primary completion date July 22, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Faculty of Physical Therapy Cairo University Giza

Sponsors (1)

Lead Sponsor Collaborator
Basma Mosaad Abd-elrahman Abushady

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. week
Primary 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. week
Primary The Six-minute walk test: The six-minute walk test (6MWT) will be done pre & post exercise program. week
Primary 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 week
Primary 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 week
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