Cardiac rehabilitation for improving heart rate response in Long COVID patients
CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19 (CARE BEAR-LC): A Proof-of-Concept, Mechanistic Trial
This study is testing if a 12-week heart rehab program can help people with Long COVID improve their exercise ability and heart rate response, while also looking at its effects on symptoms like anxiety and depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05530317 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of cardiac rehabilitation in enhancing exercise capacity and heart rate response in individuals suffering from Long COVID. Participants will undergo a 12-week rehabilitation program, with assessments of their peak oxygen consumption and other health metrics before and after the intervention. The study will also explore the impact of rehabilitation on various symptoms associated with Long COVID, including anxiety and depression. Participants must have a confirmed history of COVID-19 and exhibit reduced exercise capacity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have a confirmed history of COVID-19 and are experiencing persistent symptoms affecting their exercise capacity.
Not a fit: Patients who do not have a documented history of COVID-19 or those whose symptoms are not related to the condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life and physical health of patients with Long COVID by enhancing their exercise capacity and heart rate response.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes for patients with chronic conditions through rehabilitation, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years or older 2. 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. 3. 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. 4. Reduced exercise capacity \<100% predicted or self-reported reduction in exercise capacity compared to pre-COVID. 5. Willing and able to actively participate in cardiac rehabilitation including attending at least 12 in person sessions at UCSF Parnassus (intervention arm only). 6. Agree to participate in the LIINC Study including the cardiovascular substudy if they are not already participating. Exclusion Criteria: 1. Pregnant or intention to become pregnant during study 2. Pre-existing congenital heart disease, heart failure, pulmonary hypertension, heart or lung transplant, or cardiac valve surgery 3. 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) 4. Acute myocarditis diagnosed \<90 days prior 5. Atrial fibrillation, atrial flutter, or other arrhythmias requiring antiarrhythmic therapy 6. Use of beta-blockers, non-dihydropyridine calcium channel blockers or ivabradine 7. Implanted pacemaker or defibrillator 8. Chronic lung disease requiring the use of home oxygen therapy 9. Inability to ride a sitting bicycle for CPET 10. Severe post-exertional malaise or symptom worsening that would preclude participation in cardiac rehabilitation 11. Medical or psychological comorbidities that would prevent safe participation in the trial, in the opinion of the Principal Investigator
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Matthew S Durstenfeld, MD MAS — University of California, San Francisco
- Study coordinator: Matthew S Durstenfeld, MD MAS
- Email: matthew.durstenfeld@ucsf.edu
- Phone: 628-206-5562
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.