Relaxation Exercise in Patients With COVID-19
An Integrated Relaxation Protocol Improves Immune Biomarkers and Reduces COVID-19 Severity and Progression in Patients With COVID-19
1 other identifier
interventional
30
1 country
1
Brief Summary
the aim of this study is to investigate the effect of relaxation techniques on immune biomarkers and disease severity and progression in patients with COVID-19 and the period to which these changes last.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable covid19
Started Dec 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedFirst Submitted
Initial submission to the registry
August 8, 2021
CompletedFirst Posted
Study publicly available on registry
August 10, 2021
CompletedMarch 21, 2022
August 1, 2021
5 months
August 8, 2021
March 6, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Immune biomarkers
5 months
Wisconsin Upper Respiratory Symptom Survey
5 months
Study Arms (2)
Intervention
EXPERIMENTALThe intervention group performed two types of relaxation techniques, that have shown their positive effects on immune functions, including progressive muscle relaxation exercise (PMRs)16 and cognitive-behavioral stress management (CBSM). We used two types of relaxation techniques to produce maximum effects of relaxation techniques within the limited period of COVID-19 quarantine (2 weeks). the control groups did not receive any treatment during the study; however, they were treated afterwards.
Control
NO INTERVENTIONInterventions
The intervention group performed two types of relaxation techniques, that have shown their positive effects on immune functions, including progressive muscle relaxation exercise (PMRs)16 and cognitive-behavioral stress management (CBSM)32. We used two types of relaxation techniques to produce maximum effects of relaxation techniques within the limited period of COVID-19 quarantine (2 weeks). the control groups did not receive any treatment during the study; however, they were treated afterwards.
Eligibility Criteria
You may qualify if:
- A recent mild or moderate COVID-19 with no or low-grade fever 99.5- 100.94 °F (37.5-38.3 °C)
You may not qualify if:
- Any patient was not hospitalized and had high-grade fever \<100.94 °F (\<38.3 °C) or other chronic diseases such as heart problems, hypertension, or diabetes. Women how were using contraceptives were excluded because contraceptives decrease immune functions and might affect the subjectivity to autoimmune disorders with marked increases in risk for various autoimmune disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Gelisim University
Istanbul, Turkey (Türkiye)
Related Publications (1)
Alawna M, Mohamed AA. An integrated intervention combining cognitive-behavioural stress management and progressive muscle relaxation improves immune biomarkers and reduces COVID-19 severity and progression in patients with COVID-19: A randomized control trial. Stress Health. 2022 Dec;38(5):978-988. doi: 10.1002/smi.3151. Epub 2022 Apr 20.
PMID: 35393715DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
August 8, 2021
First Posted
August 10, 2021
Study Start
December 1, 2020
Primary Completion
April 30, 2021
Study Completion
April 30, 2021
Last Updated
March 21, 2022
Record last verified: 2021-08