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Long COVIDNCT06404073

RECOVER-ENERGIZE Platform Protocol_Appendix B (Structured Pacing (PEM))

A study testing Structured Pacing 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?
Structured Pacing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
17 Jul 2024to 17 Nov 2025
Phase
Interventional

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
  • See NCT06404047 for RECOVER-ENERGIZE: Platform Protocol level inclusion and exclusion criteria which applies to this appendix

Additional Appendix B (Structured Pacing (PEM)) Level Inclusion Criteria:

  1. Participant identifies new PEM following a SARS-CoV-2 infection that has persisted for at least 12 weeks and is still present at the time of consent
  2. 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 Screening mDSQ-PEM, and response of >14 h in item 9. or Score of 3 or greater on any severity question(regardless) and answer of YES to either item 7 or 8 on the Screening mDSQ-PEM, and response of >14h in item 9.

Additional Appendix B (Structured Pacing (PEM)) Level Exclusion Criteria:

  1. Inability to attend in-person screening visit or participate in weekly visits (in-person [≥ 1] and remote)
  2. Participant was previously enrolled in Appendix A of this protocol and has NOT completed the full study follow-up period of Appendix A

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
Structured Pacing, Usual Care
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.

  • Structured PacingBehavioural

    Participants in this group will complete weekly pacing sessions for 12 weeks. Pacing sessions will last about 30 minutes, as tolerated. Each participant will meet with a provider 'pacing coach' who has received study-specific education about PEM and how to create and manage pacing strategies for participants. Sessions include PEM symptom and trigger assessment; task, function and activity analysis; adaptations and modifications.

  • Usual CareOther

    Participants in this group will receive basic education about PEM with a weekly call by site study staff for support and communication.

Study groups in NCT06404073
Study groupRoleWhat they receive
Structured Pacing (PEM)ExperimentalParticipants in this group will complete weekly pacing sessions for 12 weeks. Pacing sessions will last about 30 minutes, as tolerated. Each participant will meet with a provider 'pacing coach' who has received study-specific education about PEM and how to create and manage pacing strategies for participants. Sessions include PEM symptom and trigger assessment; task, function and activity analysis; adaptations and modifications.
Receives: Behavioral: Structured Pacing
Usual CareOtherParticipants in this group will receive basic education about PEM with a weekly call by site study staff for support and communication.
Receives: Other: Usual Care

What is being measured

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

  1. Change in Frequency of PEM Symptoms, as Measured by the Modified DePaul Symptom - Post-Exertional Malaise Questionnaire (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 12 (End Of Intervention, EOI)

  2. Change in Severity of PEM Symptoms, as Measured by the Modified DePaul Symptom - Post-Exertional Malaise Questionnaire (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 12 (EOI)

  3. Change in Duration of PEM Symptoms, as Measured by the Modified DePaul Symptom - Post-Exertional Malaise Questionnaire (mDSQ-PEM)

    Ordinal categorical response: <=1 hour, 2-3 hours, 4-10 hours, 11-13 hours, 14-23 hours, >=24 hours. Reported as the number of participants who provided each response.

    Measured: Baseline, week 12 (EOI)

Secondary outcomes (6)

  1. Change in PASC Symptoms, as Measured by the PROMIS-Cog Questionnaire

    The PROMIS Short Form v.2.0 - Cognitive Function 8a (PROMIS-Cog) is the PROMIS Short Form to assess cognitive function and is a self-report, 8-item questionnaire targeting cognitive function in the past seven days. T-Scores in a healthy reference population have mean=50 and standard deviation = 10, with higher scores indicating higher functioning.

    Measured: Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)

  2. Change in Quality of Life, as Measured by the PROMIS-29+2

    The PROMIS-29+2 is used to calculate a preference score (PROPr) by the addition of two Cognitive Function Ability items. Preference-based scores provide an overall summary of health-related quality of life on a common metric. Preference-based scores summarize multiple domains on a metric ranging from 0 (as bad as dead) to 1 (perfect or ideal health).

    Measured: Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)

  3. Change in Quality of Life, as Measured by the EQ-5D 5L

    The EQ-5D is a standardized measure of health status. Mobility was measured on a scale from 1 (no problems in walking) to 5 (unable to walk).

    Measured: Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)

  4. Change in Step Count (Physical Activity) as Measured by Actigraphy

    Actigraphy will be measured by Fitbit. Participant steps were considered valid from days where they wore the Fitbit at least 10 waking hours. Average steps were calculated from subjects with at least 5 consecutive days of valid data within a week window of their expected visit dates.

    Measured: Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)

  5. Change in Physical Activity, 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. T-Scores in a healthy reference population have mean = 50 and standard deviation = 10, with higher scores indicating higher functioning.

    Measured: Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)

  6. Change in Orthostatic Hypotension, as Measured by the Modified Orthostatic Hypotension Questionnaire (mOHQ)

    The Orthostatic Hypotension Questionnaire (OHQ) is a measure of orthostatic intolerance. The modified OHQ (mOHQ) measure used in this study includes a total of ten items related to daily activities and symptoms. The OHQ composite score ranges from 0 (no burden) to 10 (maximal burden). Higher scores are worse. The OHQ composite score includes 6 symptom items (OISA) and 4 daily activity items (OIDAS).

    Measured: Screening, week 6 (Middle of Intervention), week 12 (EOI), month 6 (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 completion18 Aug 2025
  4. Study completion17 Nov 2025

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 or post-exertional malaise (PEM). 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
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06404073
Sponsor's protocol ID
Pro00112409_B
Other IDs
OT2HL156812, NHLBI Grant to RTI
Status last verified
Oct 2026
First submitted
3 May 2024
Last updated
6 Oct 2026
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

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