Merging Yoga and Self-Management Skills for Symptoms of Long COVID (MYS LCOVID-19)

A Mobile Intervention Merging Yoga and Self-Management Skills (MY-Skills Mobile) for Individuals Experiencing Symptoms of Long COVID-19

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Long COVID
• Intervention / Treatment: Behavioral: MY-Skills for Long COVID

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Portz, PhD, MSW; Phone Number: 303-724-8856; Email: jennifer.portz@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • UCHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MY-Skills Mobile; 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.

Behavioral: MY-Skills for Long COVID; 8 week online intervention with therapeutic yoga and self-management education

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Jennifer Portz, PhD, MSW, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 22-2215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No