NCT05530317Terminated
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
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Reason given: PI changed institutions, exploring restarting at new institution
Brief summary (registry, in English)
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).
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 13 (actual)
- First submitted
- 2 Sept 2022
- Start date
- 21 Dec 2022
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- University of California, San Francisco
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT05530317
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute myocarditis diagnosed <90 days prior
Other illness
- Pre-existing congenital heart disease, heart failure, pulmonary hypertension, heart or lung transplant, or cardiac valve surgery
- Atrial fibrillation, atrial flutter, or other arrhythmias requiring antiarrhythmic therapy
- Chronic lung disease requiring the use of home oxygen therapy
- Severe post-exertional malaise or symptom worsening that would preclude participation in cardiac rehabilitation
Lab values
- 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)
- Use of beta-blockers, non-dihydropyridine calcium channel blockers or ivabradine
Other
- Pregnant or intention to become pregnant during study
- Implanted pacemaker or defibrillator
- Inability to ride a sitting bicycle for CPET
- Medical or psychological comorbidities that would prevent safe participation in the trial, in the opinion of the Principal Investigator
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.