RECOVER-ENERGIZE Platform Protocol_Appendix A (Exercise Intolerance)

Launched by DUKE UNIVERSITY · May 6, 2024

Keywords

ClinConnect Summary

The RECOVER-ENERGIZE study is looking to help people who are experiencing exercise intolerance and fatigue after having COVID-19, a condition known as Long COVID. This trial aims to test different ways to improve how well patients can exercise, their ability to do daily activities, and their overall quality of life. It is designed to be flexible, meaning it can adapt to different treatments and settings, making it suitable for various healthcare environments.

To be eligible for this trial, participants should be between the ages of 65 and 74 and must not have certain health issues that could interfere with the study, such as uncontrolled high blood pressure or specific heart conditions. If someone joins the trial, they can expect to be part of a supportive program focused on increasing their exercise capacity and helping them manage their symptoms. This study is currently recruiting participants, and it's an opportunity for those affected by Long COVID to find new ways to feel better and improve their daily lives.

Gender

ALL

Eligibility 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