RECOVER-ENERGIZE Platform Protocol_Appendix A (Exercise Intolerance)

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: NCT06404060
• Other study ID #: Pro00112409_A
• 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: 360
• Est. completion date: January 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• See NCT06404047 for RECOVER-ENERGIZE: Platform Protocol level inclusion and exclusion criteria which applies to this appendix

Additional Appendix A (Cardiopulmonary Rehabilitation (Exercise Intolerance)) Level Exclusion Criteria:

1. Known pre-existing postural orthostatic tachycardia syndrome, not related to SARS-CoV-2 infection

2. Known uncontrolled hypertension (blood pressure [BP] = 160/100 mmHg at rest)

3. Any of the following within 4 weeks of enrollment - acute myocardial infarction, unstable angina, uncontrolled arrhythmias causing symptoms or hemodynamic compromise, acute myocarditis or pericarditis, uncontrolled acutely decompensated heart failure (acute pulmonary edema), acute pulmonary embolism, suspected dissecting aneurysm, severe hypoxemia at rest, thromboembolic event(s), any acute or chronic disorder that may affect exercise capacity or be aggravated by exercise (e.g., infection, exercise induced syncope, thyrotoxicosis, unable to cooperate)

4. 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 the Screening mDSQ-PEM, or response of > 14 hours in item 9 OR Score of 3 or greater on any severity question (regardless of frequency) AND answer of 'YES' to either item 7 or 8 on the Screening mDSQ-PEM, or response of > 14 hours in item 9 OR Score of 3 or greater on any of the severity questions on the mDSQ-PEM 48-72 hours following the Screening ISWT test

5. A selection of = 8 on question 1 or = 9 on question 3 of the OH Activity Scale from the mOHQ

6. Engaged in purposeful moderate or greater intensity exercise with the intent to improve one's health 2 or more times per week over the 30 days prior to informed consent

7. Inability to walk

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Personalized Cardiopulmonary Rehabilitation
Participants in this group will complete 2-3 cardiopulmonary rehabilitation sessions per week, for 12 weeks, as tolerated. Rehabilitation sessions are provided by respiratory therapists, exercise physiologists, physical therapists, nurses, or others who have experience and training in either pulmonary or cardiac rehabilitation. Rehabilitation sessions (adjusted based on the participant's baseline assessment, symptoms, and progress) last about 1 hour and include education, aerobic exercise, strength, and flexibility training.

Other:
• Education
Participants in this group will receive two general education sessions at the start of the intervention with weekly phone/virtual follow-ups from site study staff.

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 Endurance Shuttle Walk Test (ESWT)	The ESWT consists of timed walking on a 10m course. The result is expressed as total walking time after an initial 2-minute warm-up. The ESWT is an outcome measure of exercise capacity.	Baseline, week 12 (End of Intervention (EOI))
Primary	Percentage of participants meeting pre-specified change (minimal important difference) from baseline to End of Intervention on the ESWT	The ESWT consists of timed walking on a 10m course. The result is expressed as total walking time after an initial 2-minute warm-up. The ESWT is an outcome measure of exercise capacity.	Week 12 (EOI)
Secondary	Change in physical function, 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) and week 24 End of Study (EOS)
Secondary	Change in physical function, as measured by actigraphy		Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)
Secondary	Change in symptom frequency, as measured by the Modified DePaul Symptom Questionnaire - Post-Exertional Malaise (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 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)
Secondary	Change in symptom severity, as measured by the Modified DePaul Symptom Questionnaire - Post-Exertional Malaise (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 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)
Secondary	Change in symptom duration, as measured by the Modified DePaul Symptom Questionnaire - Post-Exertional Malaise (mDSQ-PEM)		Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)

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