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OpenTrials
Completed

NCT Number: NCT05697042

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCHealth

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MY-Skills for Long COVID

Behavioral

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

Primary outcomes

  1. Feasibility- Recruitment

    Time frame: Week 1

    90% of screened patients will be eligible; 50% of eligible patients will consent

  2. Feasibility- Use

    Time frame: Week 8

    >50% yoga session attendance and modules will be completed

  3. Feasibility- Attrition

    Time frame: Week 8

    <20% attrition

  4. Feasibility-Usability

    Time frame: Week 8

    User Mobile Application Rating Scale; <90% of participants to rate intervention between 3-5 (5-point scale)

Secondary outcomes

  1. Symptom Burden Scale for Long COVID

    Time frame: 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.

  2. PROMIS Fatigue

    Time frame: Week 8

    13-item assessing fatigue experience and impact on function

  3. Brief Pain Inventory

    Time frame: Week 8

    9-item for severity of pain and impact of pain on daily function

  4. Short Form 36

    Time frame: Week 8

    36-item function, pain, mental health, emotional well-being, fatigue, and general health perception

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Acronym: MYS LCOVID-19

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2023
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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