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

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 Covid19
• Long Covid-19

Interventions

BEHAVIORAL

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.

OTHER

Usual Care

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Duke University

  lead OTHER

Principal Investigators

• Gary M Felker, MD · Duke Clinical Research Institute

• Barry Make, MD · National Jewish Health

• Lucinda Bateman, MD · Bateman Horne Center

• Janna Friedly, MD, MPH · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-17

Primary Completion

2025-08-18

Completion

2025-11-17

Countries

• United States

Study Locations