NCT05374668

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

May 10, 2022

Last Update Submit

May 26, 2022

Conditions

Keywords

PainPost-COVID-19 patientsMild symptomsQuality of lifeFunctional capacity

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Baseline

Study Arms (2)

Video-based Yoga

EXPERIMENTAL

video-based yoga (n=40) given for patients in post-covid-19 status for 8 weeks

Behavioral: Video-based Yoga Exercises

Home-based postur exercises

EXPERIMENTAL

Home exzercises were given for 8 weeks

Behavioral: Video-based Yoga Exercises

Interventions

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

Also known as: Home-based posture exercises, Control group without any activity
Home-based postur exercisesVideo-based Yoga

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istinye University

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 32007143BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 35685491BACKGROUND
  • 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.

    PMID: 33572883BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Semi-randomized controlled prospective study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

May 10, 2022

First Posted

May 16, 2022

Study Start

March 22, 2021

Primary Completion

September 22, 2021

Study Completion

April 24, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations