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

NCT ID: NCT06404073

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-17
• Study Completion Date: 2025-11-17

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.

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.

Conditions

Long COVID; Long Covid19; Long Covid-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Structured Pacing (PEM)

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.

Group Type: EXPERIMENTAL

Structured Pacing

Intervention Type: 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.

Usual Care

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

Group Type: OTHER

Usual Care

Intervention Type: OTHER

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

Interventions

Structured Pacing

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.

Intervention Type: BEHAVIORAL

Usual Care

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

Intervention Type: OTHER

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary M Felker, MD

Role: STUDY_CHAIR

Duke Clinical Research Institute

Barry Make, MD

Role: STUDY_CHAIR

National Jewish Health

Lucinda Bateman, MD

Role: STUDY_CHAIR

Bateman Horne Center

Janna Friedly, MD, MPH

Role: STUDY_CHAIR

University of Washington

Locations

All sites listed under NCT06404047

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

http://recovercovid.org/

Related Info

Other Identifiers

OT2HL156812

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NHLBI Grant to RTI

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00112409_B

Identifier Type: -

Identifier Source: org_study_id