Actively Recruiting
CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19 (CARE BEAR-LC): A Proof-of-Concept, Mechanistic Trial
Led by University of California, San Francisco · Updated on 2025-04-02
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether cardiac rehabilitation can improve exercise capacity and heart rate response during exercise in adults with Long COVID. This proof-of-concept clinical trial focuses on individuals who had confirmed COVID-19 infection and experience persistent symptoms for at least three months after the initial illness, along with reduced exercise capacity and heart rate response as measured by cardiopulmonary exercise testing (CPET). The study aims to assess changes in peak oxygen consumption (peak VO2) and heart rate reserve, along with symptoms, anxiety, depression, vascular function, and participant satisfaction. Participants who qualify will undergo 12 weeks of standard cardiac rehabilitation tailored to their baseline exercise performance. The rehabilitation program includes exercise prescribed by a Cardiac Exercise Physiologist, incorporating aerobic and resistance exercises, with options for in-person or hybrid attendance. Additional support such as dietary counseling, smoking cessation, and medication advice will be provided according to usual cardiac rehabilitation protocols. Blood samples will be collected before and after the intervention to assess biological effects. Throughout the study, participants will complete baseline and follow-up assessments, including symptom evaluation, CPET, and vascular function tests. Satisfaction with rehabilitation will be measured after 12 weeks using a net-promoter score. The study involves informed consent, physical exams, and review of COVID-19 history. Participants are expected to attend at least 12 in-person rehabilitation sessions, with a total of up to 36 sessions possible. The trial will monitor changes in exercise capacity, symptoms, mental health, inflammation, and quality of life.
CONDITIONS
Brief Title
CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed positive COVID-19 test by RNA, antigen, or antibody with documentation
- At least one COVID-related symptom lasting at least 90 days after symptom onset
- Reduced exercise capacity below predicted or self-reported decrease since before COVID
- Willing and able to attend at least 12 in-person cardiac rehabilitation sessions (intervention group only)
- Agree to participate in the LIINC study including the cardiovascular substudy if not already enrolled
You will not qualify if you...
- Pregnant or planning pregnancy during the study
- Pre-existing serious heart or lung conditions including congenital heart disease, heart failure, pulmonary hypertension, transplant, or valve surgery
- Recent heart attack, bypass surgery, or new heart failure diagnosis with low ejection fraction within 90 days prior
- Acute myocarditis diagnosed less than 90 days prior
- Heart rhythm problems needing antiarrhythmic drugs
- Current use of beta-blockers, certain calcium channel blockers, or ivabradine
- Implanted pacemaker or defibrillator
- Chronic lung disease requiring home oxygen
- Unable to ride a sitting bicycle for exercise testing
- Severe worsening of symptoms after exertion that prevents participation
- Other medical or psychological conditions that prevent safe study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 or more visits
Duration - Up to 2 weeks
Participants complete baseline assessments including symptom assessments, cardiopulmonary exercise testing, and vascular function studies before starting cardiac rehabilitation.
1 baseline visit
Duration - 12 weeks
Participants undergo 12 weeks of cardiac rehabilitation including exercise sessions tailored to individual heart rate performance, resistance exercises, and counseling on diet, smoking cessation, and medication.
At least 12 in-person sessions over 12 weeks, with additional virtual sessions possible
Duration - Up to 2 weeks
After completing cardiac rehabilitation, participants undergo follow-up assessments similar to baseline to evaluate safety, clinical, and biological impacts, including satisfaction with rehabilitation.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94110
Actively Recruiting
Research Team
M
Matthew S Durstenfeld, MD MAS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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