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Behavioral Intervention

Rehabilitation and Pacing for Long COVID

N/A

Recruiting

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 18 years of age at the time of enrollment

Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization

Must not have

Known prior diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) not related to SARS-CoV-2 infection

Known active acute SARS-CoV-2 infection ≤ 4 weeks prior to the consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing different treatments to help improve exercise intolerance and post-exertional malaise in patients with long-term symptoms after a COVID-19 infection. The goal is to find interventions that can help

Who is the study for?

Adults over 18 who had confirmed or suspected COVID-19 before May 1, 2021, experiencing lasting symptoms like fatigue and shortness of breath for at least 12 weeks. Participants must be able to give consent and complete study tasks. Only a small portion can have unconfirmed cases.

What is being tested?

The trial is testing personalized cardiopulmonary rehabilitation, structured pacing, education against usual care in improving exercise capacity and quality of life in long COVID patients. It's multi-center and randomized.

What are the potential side effects?

Since the interventions involve non-pharmaceutical measures such as rehabilitation and education, side effects are minimal but may include muscle soreness or fatigue from increased activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have had COVID-19 before, as confirmed by a health organization.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with Chronic Fatigue Syndrome not caused by COVID-19.

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I have not had an active COVID-19 infection in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total number of participants enrolled in each Appendix

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Experimental: Appendix B - Structured Pacing (PEM)Experimental Treatment2 Interventions

Appendix B is a randomized controlled trial designed to evaluate the effect of a 12-week Structured Pacing intervention on reducing the symptoms of post-exertional malaise (PEM) in participants with PASC. Participants who meet eligibility criteria for Appendix B will be assigned to either Structured Pacing (study intervention group) or Usual Care (control group) in a 1:1 ratio. The intervention duration is 12 weeks with a follow-up period of 3 months (total study duration of 6 months). Anticipated enrollment is 300 participants. Details about Appendix B: Structured Pacing (PEM) are available under NCT06404073.

Group II: Experimental: Appendix A - Cardiopulmonary Rehabilitation (Exercise Intolerance)Experimental Treatment2 Interventions

Appendix A is a randomized controlled trial designed to evaluate the effect of a 12-week personalized cardiopulmonary rehabilitation intervention on exercise tolerance in participants with PASC. Participants who meet eligibility criteria for Appendix A will be assigned to either Personalized Cardiopulmonary Rehabilitation (study intervention group) or Education (control group) in a 1:1 ratio. The intervention duration is 12 weeks with a follow-up period of 3 months (total study duration of 6 months). Anticipated enrollment is 360 participants. Details about Appendix A: Cardiopulmonary Rehabilitation (Exercise Intolerance) are available under NCT06404060.

0 / 4Eligibility criteria met