COVID-19 PandemicNCT05279443
Effect of Yoga-based Exercises of Healthcare Workers During COVID-19 Pandemic: Prospective Clinical Trial
A study testing yoga-based exercises therapy in people with COVID-19 Pandemic and Yoga, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 55 years
- Conditions the study is for
- COVID-19 Pandemic, Yoga, Exercise Therapy
- What is being tested?
- yoga-based exercises therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2021to 10 Sep 2021
- 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 23 to 55 years
- All sexes
- No healthy volunteers
- Adult
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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara City Hospital Physical Therapy and Rehabilitation Hospital
Ankara
About this study
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
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.
Read the 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).
- Conditions
- COVID-19 Pandemic, Yoga, Exercise Therapy, Mind-Body Therapies, Muscle Stretching Exercises
- Being tested
- yoga-based exercises therapy
- Keywords
- yoga, COVID-19, quality of life, healthcare workers, sleep quality
- Medical subject headings
- COVID-19, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yoga-based exercises therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| yoga-based exercises | Experimental | Not described Receives: Other: yoga-based exercises therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: eight week
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
Measured: eight week
Secondary outcomes (1)
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
Measured: eight week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start10 Mar 2021
- Primary completion10 Aug 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Refiye Önal, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279443
- Sponsor's protocol ID
- Refiye000000000000000000000001
- Status last verified
- Mar 2022
- First submitted
- 13 Mar 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05279443
- Acronym / sponsor ID
- Refiye000000000000000000000001
- Conditions
- COVID-19 Pandemic, Yoga, Exercise Therapy, Mind-Body Therapies, Muscle Stretching Exercises
- Keywords
- yoga, COVID-19, quality of life, healthcare workers, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 15 Mar 2022 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| yoga-based exercises | Experimental | Other: yoga-based exercises therapy |
Who may qualify
- Ages
- 23 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| yoga-based exercises therapyAccompanied 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. | Other | yoga-based exercises |
Primary outcome
Six minute walk test
Time frame: eight week
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
Time frame: eight week
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
1 secondary outcome
Beck Anxiety Inventory
Time frame: eight week
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 15 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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 yoga-based exercises therapy in people with COVID-19 Pandemic and Yoga, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 Mar 2022. 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 Turkey (Türkiye). 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?
Six minute walk test (time frame: eight week). The study lists 2 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 15 Mar 2022.