Back to resultsThe Effects of Video-based Yoga Interventions for Patients With Post-corona Virus Disease (Yoga)
Primary Purpose
Post-COVID-19
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Video-based Yoga Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Post-COVID-19 focused on measuring Pain, Post-COVID-19 patients, Mild symptoms, Quality of life, Functional capacity
Eligibility Criteria
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
Sites / Locations
- Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istinye University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Video-based Yoga
Home-based postur exercises
Arm Description
video-based yoga (n=40) given for patients in post-covid-19 status for 8 weeks
Home exzercises were given for 8 weeks
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05374668
Brief Title
The Effects of Video-based Yoga Interventions for Patients With Post-corona Virus Disease
Acronym
Yoga
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
September 22, 2021 (Actual)
Study Completion Date
April 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istinye University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-COVID-19
Keywords
Pain, Post-COVID-19 patients, Mild symptoms, Quality of life, Functional capacity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Semi-randomized controlled prospective study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Video-based Yoga
Arm Type
Experimental
Arm Description
video-based yoga (n=40) given for patients in post-covid-19 status for 8 weeks
Arm Title
Home-based postur exercises
Arm Type
Experimental
Arm Description
Home exzercises were given for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Video-based Yoga Exercises
Other Intervention Name(s)
Home-based posture exercises, Control group without any activity
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain Assessment by McGill-Melzack Pain Questionnaire
Description
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.
Time Frame
Baseline
Title
Balance and gait assessment
Description
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.
Time Frame
At the beginning of the interventions
Title
Quality of life assessment by WHOQOL-BREF
Description
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.
Time Frame
Baseline
Title
Muscle Power assessment by handheld dynamometer (MicroFet 2; kgm, Hoggan Scientific, Salt Lake City, UT, USA)
Description
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.
Time Frame
Baseline
Title
Pain Assessmentby McGill-Melzack Pain Questionnaire
Description
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.
Time Frame
Baseline
Title
Balance and gait assessment by TBGA
Description
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.
Time Frame
Balance
Title
Quality of life assessment of WHOQOL-BREF
Description
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.
Time Frame
Baseline
Title
Muscle Power assessment by handheld dynamometer (MicroFet 2; kgm; Hoggan Scientific, Salt Lake City, USA)
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istinye University
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32007143
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
35685491
Citation
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.
Results Reference
background
PubMed Identifier
33572883
Citation
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.
Results Reference
background
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The Effects of Video-based Yoga Interventions for Patients With Post-corona Virus Disease
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