Platform for improving exercise intolerance in Long COVID patients
RECOVER-ENERGIZE: A Platform Protocol for Evaluation of Interventions for Exercise Intolerance in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
This study is trying different ways to help people with Long COVID feel better and improve their ability to exercise and do daily activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06404060 on ClinicalTrials.gov |
What this trial studies
This platform protocol is designed to evaluate various interventions aimed at improving exercise intolerance and post-exertional malaise (PEM) in patients suffering from Long COVID. It employs a multi-center, multi-arm, randomized, controlled approach, allowing for flexibility in interventions tailored to individual patient needs. Participants will be screened for eligibility and assigned to specific intervention appendices, where they will be randomized to receive either the intervention or a control treatment. The goal is to enhance exercise capacity, daily activity tolerance, and overall quality of life for those affected by Post-Acute Sequelae of SARS-CoV-2 Infection (PASC).
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Long COVID who experience exercise intolerance and PEM.
Not a fit: Patients with pre-existing conditions that severely affect exercise capacity or those with uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life and functional capacity for patients suffering from Long COVID.
How similar studies have performed: Other studies have explored interventions for Long COVID, but this platform approach is relatively novel and aims to adapt based on emerging evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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, and 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, and response of \> 14 hours in item 9 OR Any 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
Where this trial is running
Durham, North Carolina
- All sites listed under NCT06404047 — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Nilda Itchon-Ramos
- Email: recoverresearch@duke.edu
- Phone: 919-668-8060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.