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The Effects of Video-based Yoga Interventions for Patients With Post-corona Virus Disease (Yoga)

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ClinicalTrials.gov Identifier: NCT05374668
Recruitment Status : Completed
First Posted : May 16, 2022
Last Update Posted : June 1, 2022
Sponsor:
Information provided by (Responsible Party):
Habibe Serap Inal, Istinye University

Study Description
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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?

Condition or disease Intervention/treatment Phase
Post-COVID-19 Behavioral: Video-based Yoga Exercises Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Semi-randomized controlled prospective study.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 22, 2021
Actual Primary Completion Date : September 22, 2021
Actual Study Completion Date : April 24, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Video-based Yoga
video-based yoga (n=40) given for patients in post-covid-19 status for 8 weeks
 Behavioral: Video-based Yoga Exercises
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:
  • Home-based posture exercises
  • Control group without any activity
Experimental: Home-based postur exercises
Home exzercises were given for 8 weeks
 Behavioral: Video-based Yoga Exercises
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:
  • Home-based posture exercises
  • Control group without any activity


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05374668


Locations
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Turkey
Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istinye University
Istanbul, Turkey, 34010
Sponsors and Collaborators
Istinye University
More Information
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Publications:
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.

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Responsible Party: Habibe Serap Inal, Prof.Dr., Istinye University
ClinicalTrials.gov Identifier: NCT05374668    
Other Study ID Numbers: Yoga COVID-19
First Posted: May 16, 2022    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Habibe Serap Inal, Istinye University:
Pain
Post-COVID-19 patients
Mild symptoms
Quality of life
Functional capacity
Additional relevant MeSH terms:
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COVID-19
Virus Diseases
Coronavirus Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
 Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases