Long COVIDMYS LCOVID-19NCT05697042
Merging Yoga and Self-Management Skills for Symptoms of Long COVID
A study testing MY-Skills for Long COVID in people with Long COVID, run by University of Colorado, Denver at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID
- What is being tested?
- MY-Skills for Long COVID
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- current yoga ≥120 minutes a week
- completed self-management education in the last year
- cognitive impairment limiting participation in decision making
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Long COVID
- Being tested
- MY-Skills for Long COVID
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MY-Skills for Long COVIDBehavioural
8 week online intervention with therapeutic yoga and self-management education
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: MY-Skills for Long COVID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility- Recruitment
90% of screened patients will be eligible; 50% of eligible patients will consent
Measured: Week 1
Feasibility- Use
>50% yoga session attendance and modules will be completed
Measured: Week 8
Feasibility- Attrition
<20% attrition
Measured: Week 8
Feasibility-Usability
User Mobile Application Rating Scale; <90% of participants to rate intervention between 3-5 (5-point scale)
Measured: Week 8
Secondary outcomes (4)
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.
Measured: Week 8
PROMIS Fatigue
13-item assessing fatigue experience and impact on function
Measured: Week 8
Brief Pain Inventory
9-item for severity of pain and impact of pain on daily function
Measured: Week 8
Short Form 36
36-item function, pain, mental health, emotional well-being, fatigue, and general health perception
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Feb 2023
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Portz, PhD, MSW, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697042
- Sponsor's protocol ID
- 22-2215
- Acronym
- MYS LCOVID-19
- Status last verified
- May 2024
- First submitted
- 14 Dec 2022
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Intervention Merging Yoga and Self-Management Skills (MY-Skills Mobile) for Individuals Experiencing Symptoms of Long COVID-19
- ClinicalTrials.gov ID
- NCT05697042
- Acronym / sponsor ID
- MYS LCOVID-19 / 22-2215
- Conditions
- Long COVID
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MY-Skills Mobile | Experimental | Behavioral: MY-Skills for Long COVID8-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- current yoga ≥120 minutes a week
- completed self-management education in the last year
- cognitive impairment limiting participation in decision making
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MY-Skills for Long COVID8 week online intervention with therapeutic yoga and self-management education | Behavioural | MY-Skills Mobile |
Primary outcome
Feasibility- Recruitment
Time frame: Week 1
90% of screened patients will be eligible; 50% of eligible patients will consent
Feasibility- Use
Time frame: Week 8
>50% yoga session attendance and modules will be completed
Feasibility- Attrition
Time frame: Week 8
<20% attrition
Feasibility-Usability
Time frame: Week 8
User Mobile Application Rating Scale; <90% of participants to rate intervention between 3-5 (5-point scale)
4 secondary outcomes
Symptom Burden Scale for Long COVID
Time frame: Week 8
PROMIS Fatigue
Time frame: Week 8
Brief Pain Inventory
Time frame: Week 8
Short Form 36
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Portz, PhD, MSW principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MY-Skills for Long COVID in people with Long COVID, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility- Recruitment (time frame: Week 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.