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Platform for improving exercise tolerance in Long COVID patients

RECOVER-ENERGIZE: A Platform Protocol for Evaluation of Interventions for Exercise Intolerance in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

Not applicable Interventional Duke University · NCT06404047

This study is testing different ways to help people with Long COVID feel better and exercise more easily, including personalized rehab and education.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment660 (estimated)
Ages18 Years and up
SexAll
SponsorDuke University Academic / other
Locations42 sites (Birmingham, Alabama and 41 other locations)
Trial IDNCT06404047 on ClinicalTrials.gov

What this trial studies

This platform protocol is designed to evaluate various interventions aimed at improving exercise intolerance and post-exertional malaise (PEM) in patients suffering from Long COVID. It is a multi-center, randomized, controlled trial that allows for flexibility in interventions, which may include personalized cardiopulmonary rehabilitation, structured pacing, education, and usual care. Participants will be screened for eligibility and then randomized to either an intervention group or a control group based on specific criteria. The goal is to enhance exercise capacity, daily activity tolerance, and overall quality of life for individuals affected by Post-Acute Sequelae of SARS-CoV-2 Infection (PASC).

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have had a previous suspected, probable, or confirmed SARS-CoV-2 infection.

Not a fit: Patients who do not have a history of SARS-CoV-2 infection or those under 18 years of age may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the quality of life and daily functioning for patients suffering from Long COVID.

How similar studies have performed: Other studies have shown promise in addressing similar issues related to Long COVID, but this platform approach is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. ≥ 18 years of age at the time of enrollment
2. Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization\*

   * Suspected\* or probable SARS-CoV-2 infection will only be allowed if it occurred before May 1, 2021, and will be limited to no more than 10% of the study population. Otherwise, confirmed cases are required.

   Suspected case of SARS-CoV-2 infection - Three options, A through C:

   A. A person who meets the clinical OR epidemiological criteria. Clinical criteria: Acute onset of fever AND cough (influenza-like illness) OR Acute onset of ANY THREE OR MORE of the following signs or symptoms: fever, cough, general, weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnea, nausea, diarrhea, anorexia. Epidemiological criteria: Contact of a probable or confirmed case or linked to a COVID-19 cluster; or B. Acute respiratory infection with history of fever or measured fever of ≥ 38°C; and cough; with onset within the last 10 days; and who requires hospitalization; or C. With no clinical signs or symptoms, NOR meeting epidemiologic criteria with a positive professional use or self-test SARS-CoV-2 Antigen-Rapid Diagnostic Test.

   Probable case of SARS-CoV-2 infection:

   A. A patient who meets clinical criteria above AND is a contact of a probable or confirmed case or is linked to a COVID-19 cluster.

   Confirmed case of SARS-CoV-2 infection - Two options, A and B:

   A. A person with a positive nucleic acid amplification test, regardless of clinical criteria OR epidemiological criteria; or B. Meeting clinical criteria AND/OR epidemiological criteria (See suspected case A above for criteria). With a positive professional use or self-test SARS- CoV-2 Antigen-Rapid Diagnostic Test.
3. Self-reported limitation to physical activity due to the presence of symptoms such as fatigue, shortness of breath, and/or PEM following a SARS-CoV-2 infection, that has persisted for at least 12 weeks and is present at the time of consent.
4. Willing, able, and agree to provide informed consent, complete questionnaires and outcome assessments, and participate in the study, including assigned intervention or control and study visits whether remote, hybrid, or in-person.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Known active acute SARS-CoV-2 infection ≤ 4 weeks prior to the consent.
2. Known prior diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), not related to SARS-CoV-2 infection.
3. Current or recent use (within the last 14 days) of a formal program utilizing one or more of the current study intervention(s) or similar intervention(s) to treat the underlying condition, unless a washout period is permitted per Appendices.
4. Participation in another interventional clinical trial.
5. Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study.

Where this trial is running

Birmingham, Alabama and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Long COVIDLong Covid19Long Covid-19PASCExercisePEM
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.