Merging Yoga and Self-Management Skills for Symptoms of Long COVID

Not Applicable

Completed

• Conditions: Long COVID
• Interventions: Behavioral: MY-Skills for Long COVID

• Registration Number: NCT05697042
• Lead Sponsor: University of Colorado, Denver

Brief Summary

Long COVID patients experience high symptom burden for many months after initial infection of the COVID-19 virus. This study will investigate a mobile intervention Merging Yoga and Self-Management Skills (MY-Skills Mobile) as a complementary therapy for fatigue, pain, mood and quality of life in long COVID patients at the UCHealth Center for Integrative Medicine. The study aim is to assess the feasibility and acceptability of MY-Skills Mobile and research procedures including planned assessments.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-25
• Study Start: 2023-02-01
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• patients referred to the UC Health Integrated Medicine Clinic for long COVID
• community-dwelling
• speak English
• able to provide informed consent
• stand with or without an assistive device
• complete the Exercise Assessment and Screening for You (EASY) tool; potential participants will receive instructions about safe physical activity and/or to obtain physician approval prior to enrollment.

Participants will not be excluded due to limited technology access. We will loan tablets and hotspots to participants who do not have hardware or internet.

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Exclusion Criteria

• current yoga ≥120 minutes a week
• completed self-management education in the last year
• cognitive impairment limiting participation in decision making

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MY-Skills Mobile	MY-Skills for Long COVID	8-week intervention merging yoga and self-management offered via secure remote tools including Zoom (video-conferencing software), Canvas (education software), and Qualtrics (survey software) that can be accessed via a computer or tablet. Each participant will have an initial yoga therapy individual session prior to start of group yoga. Group yoga is offered synchronously via Zoom two times per week for 60 minutes (120 minutes per week). The self-management content is delivered primarily through asynchronous tools that include educational videos, facilitated discussion boards, and interactive activities for goal setting, monitoring goals, and problem-solving practice. Self-management content is reiterated during the bi-weekly synchronous sessions, discussed as a group, and mantras are carried through both practices.

Primary Outcome Measures

Name	Time	Method
Feasibility- Attrition	Week 8	\<20% attrition
Feasibility-Usability	Week 8	User Mobile Application Rating Scale; \<90% of participants to rate intervention between 3-5 (5-point scale)
Feasibility- Recruitment	Week 1	90% of screened patients will be eligible; 50% of eligible patients will consent
Feasibility- Use	Week 8	\>50% yoga session attendance and modules will be completed

Secondary Outcome Measures

Name	Time	Method
Short Form 36	Week 8	36-item function, pain, mental health, emotional well-being, fatigue, and general health perception
Symptom Burden Scale for Long COVID	Week 8	Newly developed 14 scale for breathing, circulation, memory, thinking/communication, movement, sleep, ear/nose/throat, stomach, other symptoms and impact on daily life.
Brief Pain Inventory	Week 8	9-item for severity of pain and impact of pain on daily function
PROMIS Fatigue	Week 8	13-item assessing fatigue experience and impact on function

Trial Locations

Locations (1)

UCHealth; 🇺🇸 Aurora, Colorado, United States