Post-COVID-19YogaNCT05374668
The Effects of Video-based Yoga Interventions for Patients With Post-corona Virus Disease
A study testing Video-based Yoga Exercises in people with Post-COVID-19, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Aimed to understand if yoga exercises are superior to posture exercises as an alternative exercise therapy for relieving musculoskeletal pain, improving functional status, and improving quality of life during the post- corona virus disease (COVID-19) period? Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post-COVID-19
- What is being tested?
- Video-based Yoga Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Mar 2021to 24 Apr 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- recently diagnosed with Covid-19 and discharged from the hospital;
- being at level 0: neglected functional limitation or level 1: negligible functional limitation on the Post-Covid-19 Functional Status Scale,
- referred for physical therapy for musculoskeletal pain.
Who cannot join
- having any type of surgery in the last six months,
- being pregnant,
- being level 2 or above on the Post-Covid-19 Functional Status Scale
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istinye University
Istanbul, 34010
About this study
Official title: The Effects of Video-based Yoga Interventions on Musculoskeletal Pain and Quality of Life of Patients' Post-corona Virus Disease: a Semi-randomized Controlled Prospective Study
Aimed to understand if yoga exercises are superior to posture exercises as an alternative exercise therapy for relieving musculoskeletal pain, improving functional status, and improving quality of life during the post- corona virus disease (COVID-19) period?
Read the detailed description
Eighty five of 200 post- COVID-19 patients, who met the inclusion/exclusion criteria obtained from the records of the State Hospital. The participants were divided into video-based (VB) yoga (n=40), home-based (HB) posture exercise (n=28), and control (n=17) groups. The socio-demographic characteristics, pain status, walking and balance, and quality of life were evaluated twice, once before and eight weeks after the exercises.
- Conditions
- Post-COVID-19
- Being tested
- Video-based Yoga Exercises
- Keywords
- Pain, Post-COVID-19 patients, Mild symptoms, Quality of life, Functional capacity
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-based Yoga ExercisesBehavioural
Also called Home-based posture exercises, Control group without any activity
They were trained face-to-face with social distancing and a maximum of three participants. They were observed while practicing and necessary alerts and corrections were made. Documents related to the videos for yoga exercises and posture exercises specially prepared for this study by the qualified physiotherapist (MD) were provided to the participants
| Study group | Role | What they receive |
|---|---|---|
| Video-based Yoga | Experimental | video-based yoga (n=40) given for patients in post-covid-19 status for 8 weeks Receives: Behavioral: Video-based Yoga Exercises |
| Home-based postur exercises | Experimental | Home exzercises were given for 8 weeks Receives: Behavioral: Video-based Yoga Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment by McGill-Melzack Pain Questionnaire
Assessment of pain by McGill-Melzack Pain Questionnaire: The localization (deep-D; superficial-S) of the pain was determined by a question in the first section of the questionnaire. Subsequently, the features (20 words and 2-6 sub words of each) and severity (mild to unbearable pain, Likert scale-5) of the pain were determined by questions in the second and third section of the questionnaire. In the fourth section, the relationship between pain, time, frequency, and the affecting factors was determined. Scores (total 0-112) obtained from the sections of the survey were collected. The pain level of the patients indicated that the higher the pain, the higher the score.
Measured: Baseline
Balance and gait assessment
Balance and Gait Assessment: The total scores for balance and walking were 0-29 and 0-9, respectively. These scores aimed to reflect the fear of falling. There was no specific cutoff score. As the score increased, the fear of falling decreased.
Measured: At the beginning of the interventions
Quality of life assessment by WHOQOL-BREF
The WHOQOL-short form consists of 26 questions and measures the physical, mental, social, and environmental well-being of the adult population. The Turkish version has 27 questions. The 27th is termed the Environment-Turkish. Each area refers to the quality of life in a respective field independently. The area scores are calculated between 1 and 100 by The World Health Organization Quality of Life-short form: The higher the score, the higher the quality of life.
Measured: Baseline
Muscle Power assessment by handheld dynamometer (MicroFet 2; kgm, Hoggan Scientific, Salt Lake City, UT, USA)
The participants performed maximal isometric voluntary contractions (for lower extremity: M. quadriceps femoris, hamstring group muscles, M. tibialis anterior, M. gastrocnemius, and M. soleus; for upper extremity: M. triceps brachii, M. biceps brachii, and M. deltoideus: anterior, middle, and posterior heads) forcefully against the dynamometer. The dynamometer was held stationary by the physical therapist.
Measured: Baseline
Pain Assessmentby McGill-Melzack Pain Questionnaire
Assessment of pain by McGill-Melzack Pain Questinnaire: The localization (deep-D; superficial-S) of the pain was determined by a question in the first section of the questionnaire. Subsequently, the features (20 words and 2-6 sub words of each) and severity (mild to unbearable pain, Likert scale-5) of the pain were determined by questions in the second and third section of the questionnaire. In the fourth section, the relationship between pain, time, frequency, and the affecting factors was determined. Scores (total 0-112) obtained from the sections of the survey were collected. The pain level of the patients indicated that the higher the pain, the higher the score.
Measured: Baseline
Balance and gait assessment by TBGA
Tinetti Balance and Gait Assessment: The total scores for balance and walking were 0-29 and 0-9, respectively. These scores aimed to reflect the fear of falling. There was no specific cutoff score. As the score increased, the fear of falling decreased.
Measured: Balance
Quality of life assessment of WHOQOL-BREF
The WHOQOL-short form consists of 26 questions and measures the physical, mental, social, and environmental well-being of the adult population. The Turkish version has 27 questions. The 27th is termed the Environment-Turkish. Each area refers to the quality of life in a respective field independently. The area scores are calculated between 1 and 100. by The World Health Organization Quality of Life-short form: The higher the score, the higher the quality of life.
Measured: Baseline
Muscle Power assessment by handheld dynamometer (MicroFet 2; kgm; Hoggan Scientific, Salt Lake City, USA)
The participants performed maximal isometric voluntary contractions (for lower extremity: M. quadriceps femoris, hamstring group muscles, M. tibialis anterior, M. gastrocnemius, and M. soleus; for upper extremity: M. triceps brachii, M. biceps brachii, and M. deltoideus: anterior, middle, and posterior heads) forcefully against the dynamometer. The dynamometer was held stationary by the physical therapist.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start22 Mar 2021
- Primary completion22 Sep 2021
- Study completion24 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-COVID-19Studies of the same condition, open and under way.
- More trials run by Istinye UniversityThe 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
- Randomised
- Intervention model
- Sequential
- Model description
- Semi-randomized controlled prospective study.
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Habibe Serap Inal, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374668
- Sponsor's protocol ID
- Yoga COVID-19
- Acronym
- Yoga
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PubMed 32007143Ince DI, Yaglı NV, Saglam M, Kutukcu, EC. Acute and Post-acut Physiotherapy and Rehabilitation in COVI-19 Infection [COVID-19 Enfeksiyonunda Akut ve Post-Akut Fizyoterapi ve Rehabilitasyon]. Turk J Physiother Rehabil. 2020; 31(1):81-93. doi: 10.21653/tjpr.718877.
Herrero-Montes M, Fernandez-de-Las-Penas C, Ferrer-Pargada D, Tello-Mena S, Cancela-Cilleruelo I, Rodriguez-Jimenez J, Palacios-Cena D, Paras-Bravo P. Prevalence of Neuropathic Component in Post-COVID Pain Symptoms in Previously Hospitalized COVID-19 Survivors. Int J Clin Pract. 2022 Mar 16;2022:3532917. doi: 10.1155/2022/3532917. eCollection 2022.
PubMed 35685491Maugeri G, Musumeci G. Adapted Physical Activity to Ensure the Physical and Psychological Well-Being of COVID-19 Patients. J Funct Morphol Kinesiol. 2021 Jan 29;6(1):13. doi: 10.3390/jfmk6010013.
PubMed 33572883
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Video-based Yoga Interventions on Musculoskeletal Pain and Quality of Life of Patients' Post-corona Virus Disease: a Semi-randomized Controlled Prospective Study
- ClinicalTrials.gov ID
- NCT05374668
- Acronym / sponsor ID
- Yoga / Yoga COVID-19
- Conditions
- Post-COVID-19
- Keywords
- Pain, Post-COVID-19 patients, Mild symptoms, Quality of life, Functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 24 Apr 2022 (actual)
- First posted
- 16 May 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.
Aimed to understand if yoga exercises are superior to posture exercises as an alternative exercise therapy for relieving musculoskeletal pain, improving functional status, and improving quality of life during the post- corona virus disease (COVID-19) period?
Detailed description
Eighty five of 200 post- COVID-19 patients, who met the inclusion/exclusion criteria obtained from the records of the State Hospital. The participants were divided into video-based (VB) yoga (n=40), home-based (HB) posture exercise (n=28), and control (n=17) groups. The socio-demographic characteristics, pain status, walking and balance, and quality of life were evaluated twice, once before and eight weeks after the exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Semi-randomized controlled prospective study.
| Arm | Type | Receives |
|---|---|---|
| Video-based Yoga | Experimental | Behavioral: Video-based Yoga Exercisesvideo-based yoga (n=40) given for patients in post-covid-19 status for 8 weeks |
| Home-based postur exercises | Experimental | Behavioral: Video-based Yoga ExercisesHome exzercises were given for 8 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- recently diagnosed with Covid-19 and discharged from the hospital;
- being at level 0: neglected functional limitation or level 1: negligible functional limitation on the Post-Covid-19 Functional Status Scale,
- referred for physical therapy for musculoskeletal pain.
Key exclusion criteria (3 listed)
- having any type of surgery in the last six months,
- being pregnant,
- being level 2 or above on the Post-Covid-19 Functional Status Scale
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 |
|---|---|---|
| Video-based Yoga ExercisesAlso: Home-based posture exercises, Control group without any activityThey were trained face-to-face with social distancing and a maximum of three participants. They were observed while practicing and necessary alerts and corrections were made. Documents related to the videos for yoga exercises and posture exercises specially prepared for this study by the qualified physiotherapist (MD) were provided to the participants | Behavioural | Home-based postur exercises, Video-based Yoga |
Primary outcome
Pain Assessment by McGill-Melzack Pain Questionnaire
Time frame: Baseline
Assessment of pain by McGill-Melzack Pain Questionnaire: The localization (deep-D; superficial-S) of the pain was determined by a question in the first section of the questionnaire. Subsequently, the features (20 words and 2-6 sub words of each) and severity (mild to unbearable pain, Likert scale-5) of the pain were determined by questions in the second and third section of the questionnaire. In the fourth section, the relationship between pain, time, frequency, and the affecting factors was determined. Scores (total 0-112) obtained from the sections of the survey were collected. The pain level of the patients indicated that the higher the pain, the higher the score.
Balance and gait assessment
Time frame: At the beginning of the interventions
Balance and Gait Assessment: The total scores for balance and walking were 0-29 and 0-9, respectively. These scores aimed to reflect the fear of falling. There was no specific cutoff score. As the score increased, the fear of falling decreased.
Quality of life assessment by WHOQOL-BREF
Time frame: Baseline
The WHOQOL-short form consists of 26 questions and measures the physical, mental, social, and environmental well-being of the adult population. The Turkish version has 27 questions. The 27th is termed the Environment-Turkish. Each area refers to the quality of life in a respective field independently. The area scores are calculated between 1 and 100 by The World Health Organization Quality of Life-short form: The higher the score, the higher the quality of life.
Muscle Power assessment by handheld dynamometer (MicroFet 2; kgm, Hoggan Scientific, Salt Lake City, UT, USA)
Time frame: Baseline
The participants performed maximal isometric voluntary contractions (for lower extremity: M. quadriceps femoris, hamstring group muscles, M. tibialis anterior, M. gastrocnemius, and M. soleus; for upper extremity: M. triceps brachii, M. biceps brachii, and M. deltoideus: anterior, middle, and posterior heads) forcefully against the dynamometer. The dynamometer was held stationary by the physical therapist.
Pain Assessmentby McGill-Melzack Pain Questionnaire
Time frame: Baseline
Assessment of pain by McGill-Melzack Pain Questinnaire: The localization (deep-D; superficial-S) of the pain was determined by a question in the first section of the questionnaire. Subsequently, the features (20 words and 2-6 sub words of each) and severity (mild to unbearable pain, Likert scale-5) of the pain were determined by questions in the second and third section of the questionnaire. In the fourth section, the relationship between pain, time, frequency, and the affecting factors was determined. Scores (total 0-112) obtained from the sections of the survey were collected. The pain level of the patients indicated that the higher the pain, the higher the score.
Balance and gait assessment by TBGA
Time frame: Balance
Tinetti Balance and Gait Assessment: The total scores for balance and walking were 0-29 and 0-9, respectively. These scores aimed to reflect the fear of falling. There was no specific cutoff score. As the score increased, the fear of falling decreased.
Quality of life assessment of WHOQOL-BREF
Time frame: Baseline
The WHOQOL-short form consists of 26 questions and measures the physical, mental, social, and environmental well-being of the adult population. The Turkish version has 27 questions. The 27th is termed the Environment-Turkish. Each area refers to the quality of life in a respective field independently. The area scores are calculated between 1 and 100. by The World Health Organization Quality of Life-short form: The higher the score, the higher the quality of life.
Muscle Power assessment by handheld dynamometer (MicroFet 2; kgm; Hoggan Scientific, Salt Lake City, USA)
Time frame: Baseline
The participants performed maximal isometric voluntary contractions (for lower extremity: M. quadriceps femoris, hamstring group muscles, M. tibialis anterior, M. gastrocnemius, and M. soleus; for upper extremity: M. triceps brachii, M. biceps brachii, and M. deltoideus: anterior, middle, and posterior heads) forcefully against the dynamometer. The dynamometer was held stationary by the physical therapist.
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 1 Jun 2022.
- Background: PubMed 32007143Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
- BackgroundInce DI, Yaglı NV, Saglam M, Kutukcu, EC. Acute and Post-acut Physiotherapy and Rehabilitation in COVI-19 Infection [COVID-19 Enfeksiyonunda Akut ve Post-Akut Fizyoterapi ve Rehabilitasyon]. Turk J Physiother Rehabil. 2020; 31(1):81-93. doi: 10.21653/tjpr.718877.
- Background: PubMed 35685491Herrero-Montes M, Fernandez-de-Las-Penas C, Ferrer-Pargada D, Tello-Mena S, Cancela-Cilleruelo I, Rodriguez-Jimenez J, Palacios-Cena D, Paras-Bravo P. Prevalence of Neuropathic Component in Post-COVID Pain Symptoms in Previously Hospitalized COVID-19 Survivors. Int J Clin Pract. 2022 Mar 16;2022:3532917. doi: 10.1155/2022/3532917. eCollection 2022.
- Background: PubMed 33572883Maugeri G, Musumeci G. Adapted Physical Activity to Ensure the Physical and Psychological Well-Being of COVID-19 Patients. J Funct Morphol Kinesiol. 2021 Jan 29;6(1):13. doi: 10.3390/jfmk6010013.
- Individual participant dataSharing planned: No
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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 Video-based Yoga Exercises in people with Post-COVID-19, run by Istinye University 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?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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 1 Jun 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?
Pain Assessment by McGill-Melzack Pain Questionnaire (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05374668, which also lists 4 linked publications.
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 1 Jun 2022.