CompletedNot Applicable

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

United States300 participantsStarted 2024-07-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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.
✕. 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

What they're measuring

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

Timeframe: 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)

Timeframe: Baseline, week 12 (EOI)

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

Timeframe: Baseline, week 12 (EOI)

Trial details

NCT IDNCT06404073

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-18

View on ClinicalTrials.gov More Long COVID trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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.
✕. 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

What they're measuring

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

Timeframe: 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)

Timeframe: Baseline, week 12 (EOI)

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

Timeframe: Baseline, week 12 (EOI)