This is a platform protocol designed to be flexible so that it is suitable for a range ofinterventions and settings within diverse health care systems and community settings withincorporation into clinical COVID-19 management programs and treatment plans if resultsachieve key study outcomes.This protocol is a prospective, multi-center, multi-arm, randomized, controlled platformtrial evaluating interventions to address and improve exercise intolerance andpost-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2Infection (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.
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.
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.
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
All sites listed under NCT06404047
Durham, North Carolina, United States
Nilda Itchon-Ramos
919-668-8060
recoverresearch@duke.edu
Barrie Harper
recoverresearch@duke.edu