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Effect of Yoga-based Exercises of Healthcare Workers During COVID-19 Pandemic: Prospective Clinical Trial

Primary Purpose

COVID-19 Pandemic, Yoga, Exercise Therapy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
yoga-based exercises therapy
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Pandemic focused on measuring yoga, COVID-19, quality of life, healthcare workers, sleep quality

Eligibility Criteria

23 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:prospective clinical trial patients who were COVID-19 PCR (+) and/or diagnosed with COVID-19 pneumonia by computed tomography, completed their medical treatment, had ongoing fatigue, dyspnea, decreased stamina, difficulty in activities of daily living, anxiety, and depression complaints, had an event duration of 2 to 6 months, were actively working (between 25-60 years of age), and had a stable general condition and cognitive ability were included in our study.

Exclusion Criteria:Patients who were hemodynamically unstable, whose cardiac and pulmonary system stability could not be maintained, who had rheumatic, neurological, and psychological disorders, and those who could not continue the program due to working conditions were determined as exclusion criteria.

Sites / Locations

  • Ankara City Hospital Physical Therapy and Rehabilitation Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

yoga-based exercises

Arm Description

Outcomes

Primary Outcome Measures

Six minute walk test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity
modified Medical Research Council (mMRC) dyspnoea scale
The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing

Secondary Outcome Measures

Beck Anxiety Inventory
The BAI is a self-report questionnaire measuring 21 common somatic and cognitive symptoms of anxiety. In a study of adults age 55 years and older in a community-based outpatient facility, the BAI was found to have good discriminant validity

Full Information

First Posted
March 13, 2022
Last Updated
March 13, 2022
Sponsor
Ankara City Hospital Bilkent
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1. Study Identification

Unique Protocol Identification Number
NCT05279443
Brief Title
Effect of Yoga-based Exercises of Healthcare Workers During COVID-19 Pandemic: Prospective Clinical Trial
Official Title
Effect of Yoga-based Exercises on Functional Capacity, Dyspnea, Quality of Life, Depression, Anxiety and Sleep of Healthcare Workers During COVID-19 Pandemic: Prospective Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
August 10, 2021 (Actual)
Study Completion Date
September 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara City Hospital Bilkent

4. Oversight

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

5. Study Description

Brief Summary
To investigate the effect of yoga-based exercises therapy on functional capacity, dyspnea, quality of life, depression, anxiety, and sleep quality in healthcare professionals following COVID-19.
Detailed Description
Twenty-six healthcare professionals who were diagnosed with COVID-19, whose treatments were completed, and who were actively working during the subacute period with ongoing complaints were included in the study. The exercises program consisting of stretching, relaxation, isometric strengthening, breathing, and meditation exercises were given to the healthcare professionals under a 60-minute yoga-based exercises program held twice a week for a period of eight weeks. Flexibility and muscle strength measurements of the patients were calculated by the sit and reach test, shoulder flexibility test, and a hand dynamometer. Functional capacity was evaluated with the 6-minute walk test (6MWT), physical activity and dyspnea severity with the modified Medical Research Council (mMRC) dyspnea scale, depression and anxiety level with the Beck Depression and Anxiety Inventory, the quality of life with the SF-36, and sleep quality with the Pittsburgh Sleep Quality Index (PSQI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pandemic, Yoga, Exercise Therapy, Mind-Body Therapies, Muscle Stretching Exercises
Keywords
yoga, COVID-19, quality of life, healthcare workers, sleep quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
yoga-based exercises
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
yoga-based exercises therapy
Intervention Description
Accompanied by a certified yoga instructor, and under the supervision of an PMR specialist and a Sports Medicine specialist, YBEs were administered to our patients included in the study for 8 weeks, 2 sessions a week, and with sessions of 60 minutes, using personal mats and equipment in a 2475 m3 (18mx25mx5.5m) gym area that belonged to our hospital, in the form of group therapy for 5 (five) people and in accordance with the social distancing rules. The exercises program was applied as a exercise program consisting of physical postures (asana) to improve the body's muscle strength and flexibility, breathing exercises (pranayama) to increase respiratory function, and relaxation and meditation (dhyana) techniques.
Primary Outcome Measure Information:
Title
Six minute walk test
Description
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity
Time Frame
eight week
Title
modified Medical Research Council (mMRC) dyspnoea scale
Description
The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing
Time Frame
eight week
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory
Description
The BAI is a self-report questionnaire measuring 21 common somatic and cognitive symptoms of anxiety. In a study of adults age 55 years and older in a community-based outpatient facility, the BAI was found to have good discriminant validity
Time Frame
eight week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:prospective clinical trial patients who were COVID-19 PCR (+) and/or diagnosed with COVID-19 pneumonia by computed tomography, completed their medical treatment, had ongoing fatigue, dyspnea, decreased stamina, difficulty in activities of daily living, anxiety, and depression complaints, had an event duration of 2 to 6 months, were actively working (between 25-60 years of age), and had a stable general condition and cognitive ability were included in our study. Exclusion Criteria:Patients who were hemodynamically unstable, whose cardiac and pulmonary system stability could not be maintained, who had rheumatic, neurological, and psychological disorders, and those who could not continue the program due to working conditions were determined as exclusion criteria.
Facility Information:
Facility Name
Ankara City Hospital Physical Therapy and Rehabilitation Hospital
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Yoga-based Exercises of Healthcare Workers During COVID-19 Pandemic: Prospective Clinical Trial

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