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

Long COVID Clinical Trial

Official title:

RECOVER-ENERGIZE: A Platform Protocol for Evaluation of Interventions for Exercise Intolerance in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06404073
• Other study ID #: Pro00112409_B
• Secondary ID: OT2HL156812NHLBI
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: January 2026

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: Nilda Itchon-Ramos
• Phone: 919-668-8060
• Email: recoverresearch[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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, or response of >14 h 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

Related Conditions & MeSH terms

• COVID-19
• Long COVID
• Long Covid-19

Intervention

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.

Locations

Country	Name	City	State
United States	All sites listed under NCT06404047	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)), month 6 (End of Study (EOS))
Primary	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), month 6 (EOS)
Primary	Change in duration of PEM symptoms, as measured by the Modified DePaul Symptom - Post-Exertional Malaise questionnaire (mDSQ-PEM)		Baseline, week 12 (EOI), month 6 (EOS)
Secondary	Change in PASC symptoms, as measured by the PASC Symptom Questionnaire	The PASC Symptom Questionnaire is a 33-question survey for self-reporting multiple PASC-related symptoms across multiple systems.	Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
Secondary	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.	Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
Secondary	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).	Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
Secondary	Change in quality of life, as measured by the EQ-5D 5L	The EQ-5D is a standardized measure of health status.	Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
Secondary	Change in physical activity, as measured by Actigraphy	Actigraphy will be measured by Fitbit.	Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
Secondary	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.	Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
Secondary	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.	Screening, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)

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