- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05374668
The Effects of Video-based Yoga Interventions for Patients With Post-corona Virus Disease (Yoga)
May 26, 2022 updated by: Habibe Serap Inal, Istinye University
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?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
85
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey, 34010
- Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istinye University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Video-based Yoga
video-based yoga (n=40) given for patients in post-covid-19 status for 8 weeks
|
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
Other Names:
|
|
EXPERIMENTAL: Home-based postur exercises
Home exzercises were given for 8 weeks
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
|
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.
|
At the beginning of the interventions
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Balance
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Ince 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.
- Maugeri 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 22, 2021
Primary Completion (ACTUAL)
September 22, 2021
Study Completion (ACTUAL)
April 24, 2022
Study Registration Dates
First Submitted
May 10, 2022
First Submitted That Met QC Criteria
May 13, 2022
First Posted (ACTUAL)
May 16, 2022
Study Record Updates
Last Update Posted (ACTUAL)
June 1, 2022
Last Update Submitted That Met QC Criteria
May 26, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Yoga COVID-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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