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Long COVIDNCT06404060

RECOVER-ENERGIZE Platform Protocol_Appendix A (Exercise Intolerance)

A study testing Personalized Cardiopulmonary Rehabilitation and Education in people with Long COVID and Long Covid19, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Long COVID, Long Covid19, Long Covid-19
What is being tested?
Personalized Cardiopulmonary Rehabilitation and Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
1 siteUnited States
Study dates
17 Jul 2024to 5 May 2026
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

  • See NCT06404047 for RECOVER-ENERGIZE: Platform Protocol level inclusion and exclusion criteria which applies to this appendix
  • Additional Appendix A (Cardiopulmonary Rehabilitation (Exercise Intolerance)) Level Exclusion Criteria:
  • Known pre-existing postural orthostatic tachycardia syndrome, not related to SARS-CoV-2 infection
  • Known uncontrolled hypertension (blood pressure [BP] ≥ 160/100 mmHg at rest)
  • Any of the following within 4 weeks of enrollment - acute myocardial infarction, unstable angina, uncontrolled arrhythmias causing symptoms or hemodynamic compromise, acute myocarditis or pericarditis, uncontrolled acutely decompensated heart failure (acute pulmonary edema), acute pulmonary embolism, suspected dissecting aneurysm, severe hypoxemia at rest, thromboembolic event(s), any acute or chronic disorder that may affect exercise capacity or be aggravated by exercise (e.g., infection, exercise induced syncope, thyrotoxicosis, unable to cooperate)
  • Score of 2 or greater for both frequency and severity for any of the first 5 questions on the Screening mDSQ-PEM AND answer of 'YES' to either item 7 or 8 on the Screening mDSQ-PEM, and response of > 14 hours in item 9 OR Score of 3 or greater on any severity question (regardless of frequency) AND answer of 'YES' to either item 7 or 8 on the Screening mDSQ-PEM, and response of > 14 hours in item 9 OR Any score of 3 or greater on any of the severity questions on the mDSQ-PEM 48-72 hours following the Screening ISWT test
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  • A selection of ≥ 8 on question 1 or ≥ 9 on question 3 of the OH Activity Scale from the mOHQ
  • Engaged in purposeful moderate or greater intensity exercise with the intent to improve one's health 2 or more times per week over the 30 days prior to informed consent
  • Inability to walk

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • All sites listed under NCT06404047

    Durham, North Carolina, 27710

Other trials in United States

About this study

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

This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes.

This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC).

The focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC.

Read the detailed description

Study interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix. Study intervention appendices may be added or removed according to adaptive design and/or emerging evidence.

The platform protocol enrolls participants who meet study eligibility criteria. After completing initial screening assessments, eligible participants are assigned to one of the study intervention appendices that are actively enrolling. Participants must meet certain criteria within a specific appendix in order to be included in that appendix. Once assigned to an appendix, eligible participants are randomized to either the study intervention group or a control group.

Being tested
Personalized Cardiopulmonary Rehabilitation, Education
Keywords
PASC, Exercise, PEM (post exertional malaise)
Medical subject headings
Post-Acute COVID-19 Syndrome, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized Cardiopulmonary RehabilitationBehavioural

    Participants in this group will complete 2-3 cardiopulmonary rehabilitation sessions per week, for 12 weeks, as tolerated. Rehabilitation sessions are provided by respiratory therapists, exercise physiologists, physical therapists, nurses, or others who have experience and training in either pulmonary or cardiac rehabilitation.

    Rehabilitation sessions (adjusted based on the participant's baseline assessment, symptoms, and progress) last about 1 hour and include education, aerobic exercise, strength, and flexibility training.

  • EducationOther

    Participants in this group will receive two general education sessions at the start of the intervention with weekly phone/virtual follow-ups from site study staff.

Study groups in NCT06404060
Study groupRoleWhat they receive
Cardiopulmonary Rehabilitation (Exercise Intolerance)ExperimentalParticipants assigned to Cardiopulmonary Rehabilitation will undergo a 12-week personalized cardiopulmonary rehabilitation intervention with a follow-up period of 3 months (total study duration of 6 months).
Receives: Behavioral: Personalized Cardiopulmonary Rehabilitation
EducationActive comparatorParticipants in this group will receive two general education sessions at the start of the intervention with weekly phone/virtual follow-ups from site study staff.
Receives: Other: Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Endurance Shuttle Walk Test (ESWT)

    The ESWT consists of timed walking on a 10m course. The result is expressed as total walking time after an initial 2-minute warm-up. The ESWT is an outcome measure of exercise capacity.

    Measured: Baseline, week 12 (End of Intervention (EOI))

Secondary outcomes (5)

  1. Change in physical function, as measured by the PROMIS SF-Physical Function (PROMIS-PF)

    The PROMIS Short Form v2.0 - Physical Function 8b (PROMIS-PF) consists of 8 items. The PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities.

    Measured: Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)

  2. Change in physical function, as measured by actigraphy

    Measured: Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)

  3. Change in symptom frequency, as measured by the Modified DePaul Symptom Questionnaire - Post-Exertional Malaise (mDSQ-PEM)

    Symptom frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time.

    Measured: Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)

  4. Change in symptom severity, as measured by the Modified DePaul Symptom Questionnaire - Post-Exertional Malaise (mDSQ-PEM)

    Symptom severity is rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.

    Measured: Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)

  5. Change in symptom duration, as measured by the Modified DePaul Symptom Questionnaire - Post-Exertional Malaise (mDSQ-PEM)

    Measured: Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2024
  2. Study start17 Jul 2024
  3. Primary completion10 Mar 2026
  4. Study completion5 May 2026

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This platform protocol is designed to allocate participants into an appropriate intervention appendix based on their symptoms of exercise intolerance. Once assigned to an appendix, eligible participants are randomized in a 1:1 ratio to either the study intervention group or a control group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06404060
Sponsor's protocol ID
Pro00112409_A
Other IDs
OT2HL156812, NHLBI Grant to RTI
Status last verified
Jul 2026
First submitted
3 May 2024
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The summary of the results will be shared on the study website: https://recovercovid.org/

Publications

  • Friedly J, Bateman L, Berdan LG, Casaburi R, Erdmann N, Felker GM, Itchon-Ramos N, Keteyian SJ, MacIntyre N, O'Brien L, Reist C, Rossiter HB, Silverstein A, Taylor E, Pike Welch H, Yanez ND, Zimmerman KO, Make B. Rationale and Design of RECOVER-ENERGIZE: A Platform Clinical Trial of Interventions for Exercise Intolerance With and Without Post-exertional Malaise in Long COVID. medRxiv [Preprint]. 2026 Jun 3:2026.06.02.26354455. doi: 10.64898/2026.06.02.26354455.

    PubMed 42282195

Questions about this trial

What is this clinical trial studying?

A study testing Personalized Cardiopulmonary Rehabilitation and Education in people with Long COVID and Long Covid19, run by Duke University 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 9 inclusion and 0 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 8 Jul 2026. 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?

Change in Endurance Shuttle Walk Test (ESWT) (time frame: Baseline, week 12 (End of Intervention (EOI))). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06404060, which also lists 1 linked publication.

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 8 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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