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

NCT05697042 | Completed

• 1 other identifier: 22-2215
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Long COVID

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Symptom Burden Scale for Long COVID

  Week 8

• PROMIS Fatigue

  Week 8

• Brief Pain Inventory

  Week 8

• Short Form 36

  Week 8

Study Arms (1)

MY-Skills Mobile

EXPERIMENTAL

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

Interventions

MY-Skills for Long COVID BEHAVIORAL

8 week online intervention with therapeutic yoga and self-management education

MY-Skills Mobile

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

UCHealth

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Portz, PhD, MSW

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 25, 2023
• Study Start: February 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

US (1)