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

NCT06404073 | Completed DMC

• 3 other identifiers: Pro00112409_BOT2HL156812NHLBI Grant to RTI
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Long COVID; Long Covid-19

Keywords

PASC; Exercise; PEM (post exertional malaise)

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline, week 12 (End Of Intervention (EOI)

• 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.

  Baseline, week 12 (EOI)

• Change in duration of PEM symptoms, as measured by the Modified DePaul Symptom - Post-Exertional Malaise questionnaire (mDSQ-PEM)

  Baseline, week 12 (EOI)

Secondary Outcomes (7)

• Change in PASC symptoms, as measured by the PASC Symptom Questionnaire

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

• Change in PASC symptoms, as measured by the PROMIS-Cog Questionnaire

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

• Change in quality of life, as measured by the PROMIS-29+2

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

• Change in quality of life, as measured by the EQ-5D 5L

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

• Change in physical activity, as measured by Actigraphy

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

Study Arms (2)

Structured Pacing (PEM)

EXPERIMENTAL

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.

Behavioral: Structured Pacing

Usual Care

OTHER

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

Other: Usual Care

Interventions

Structured Pacing BEHAVIORAL

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.

Structured Pacing (PEM)

Usual Care OTHER

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

All sites listed under NCT06404047

Durham, North Carolina, 27710, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Gary M Felker, MD

  Duke Clinical Research Institute

  STUDY CHAIR

• Barry Make, MD

  National Jewish Health

  STUDY CHAIR

• Lucinda Bateman, MD

  Bateman Horne Center

  STUDY CHAIR

• Janna Friedly, MD, MPH

  University of Washington

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 8, 2024
• Study Start: July 17, 2024
• Primary Completion: August 18, 2025
• Study Completion: November 17, 2025
• Last Updated: May 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)