CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19
CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19 (CARE BEAR-LC): A Proof-of-Concept, Mechanistic Trial
University of California, San Francisco
20 participants
Dec 21, 2022
INTERVENTIONAL
Conditions
Summary
The goal of this proof-of-concept clinical trial is to determine whether cardiac rehabilitation improves exercise capacity and chronotropic (heart rate) response to exercise among people with Long COVID. The study will include individuals with confirmed SARS-CoV-2 infection, symptoms not present prior to COVID-19 that are persistent for at least 3 months after acute infection ("Long COVID"), and who have reduced exercise capacity less than predicted and reduced heart rate response during cardiopulmonary exercise testing (CPET). In addition to the primary outcome of change in peak VO2, secondary outcomes will include change in symptoms including autonomic symptoms (COMPASS-31), anxiety (GAD-7), depression (PHQ-9), endothelial function with brachial artery flow-mediated dilation, and satisfaction (net-promotor score).
Eligibility
Inclusion Criteria6
- Age 18 years or older
- Previously documented SARS-CoV-2 RNA positivity from an oral or nasal swab, as measured by a nucleic acid amplification test, documented positive antigen testing, or positive nucleocapsid antibody. Documentation of the positive test is required.
- Presence of persistent symptoms, defined as at least one COVID-attributed symptom newly present during acute illness or worse than baseline and reported to still be present for at least 90 days following symptom onset. This will be ascertained using study case report forms.
- Reduced exercise capacity <100% predicted or self-reported reduction in exercise capacity compared to pre-COVID.
- Willing and able to actively participate in cardiac rehabilitation including attending at least 12 in person sessions at UCSF Parnassus (intervention arm only).
- Agree to participate in the LIINC Study including the cardiovascular substudy if they are not already participating.
Exclusion Criteria11
- Pregnant or intention to become pregnant during study
- Pre-existing congenital heart disease, heart failure, pulmonary hypertension, heart or lung transplant, or cardiac valve surgery
- Myocardial infarction, or coronary artery bypass graft surgery, or new diagnosis of heart failure with a reduced ejection fraction <40% within 90 days prior to enrollment (Class I indications for cardiac rehabilitation)
- Acute myocarditis diagnosed <90 days prior
- Atrial fibrillation, atrial flutter, or other arrhythmias requiring antiarrhythmic therapy
- Use of beta-blockers, non-dihydropyridine calcium channel blockers or ivabradine
- Implanted pacemaker or defibrillator
- Chronic lung disease requiring the use of home oxygen therapy
- Inability to ride a sitting bicycle for CPET
- Severe post-exertional malaise or symptom worsening that would preclude participation in cardiac rehabilitation
- Medical or psychological comorbidities that would prevent safe participation in the trial, in the opinion of the Principal Investigator
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Interventions
Exercise prescriptions will be based on the heart rate performance during the baseline CPET. The intensity of the exercise prescription and level of monitoring will be tailored to the individual participant's performance on their baseline CPET according to guidelines. Exercise will be prescribed by a Cardiac Exercise Physiologist in accordance with standard cardiac rehabilitation protocols with special attention to post-exertional malaise. Resistance exercise activities will also be incorporated. Recumbent exercise will be utilized based on assessment by exercise physiologist and patient. Dietary counseling, smoking cessation counseling for smokers, and medication counseling will be incorporated according to standard cardiac rehabilitation protocols. Most participants will participate in a hybrid approach (12-16 sessions in person), but participants will be allowed to select a fully in-person approach (36 sessions).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05530317