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

Long COVID Clinical Trial

— MYS LCOVID-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05697042
• Other study ID #: 22-2215
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Long COVID

Intervention

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

Locations

Country	Name	City	State
United States	UCHealth	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility- Recruitment	90% of screened patients will be eligible; 50% of eligible patients will consent	Week 1
Primary	Feasibility- Use	>50% yoga session attendance and modules will be completed	Week 8
Primary	Feasibility- Attrition	<20% attrition	Week 8
Primary	Feasibility-Usability	User Mobile Application Rating Scale; <90% of participants to rate intervention between 3-5 (5-point scale)	Week 8
Secondary	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
Secondary	PROMIS Fatigue	13-item assessing fatigue experience and impact on function	Week 8
Secondary	Brief Pain Inventory	9-item for severity of pain and impact of pain on daily function	Week 8
Secondary	Short Form 36	36-item function, pain, mental health, emotional well-being, fatigue, and general health perception	Week 8