CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19 (CARE BEAR-LC): A Proof-of-Concept, Mechanistic Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in adjusted heart rate reserve
研究概览
简要总结
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).
详细描述
Study Overview
This single-center, proof-of-concept mechanistic study of cardiac rehabilitation will use a pre-post design to establish whether there is any effect of cardiac rehabilitation on adjusted heart rate reserve achieved and peak oxygen consumption (peak VO2) in LC.
Once a participant is identified as potentially eligible, they will be contacted by the study team. Participants will be asked to co-enroll in the Long-term Impact of Infection with Novel Coronavirus observational cohort ("LIINC" NCT 04362150). If participants do not agree to be co-enrolled in LIINC (if they are not already included) and the Cardiovascular Sub-Study, they will not be allowed to enroll.
Participants will be consented by the PI or research team before any procedures take place. Participants who provide written informed consent and meet the inclusion criteria will be enrolled into the study. They undergo a series of baseline measurements as outlined in the Schedule of Events. They will participate in 12 weeks of cardiac rehabilitation and then undergo follow-up measurements to determine the safety, clinical impact, and biological impact of the therapy as outlined in the Schedule of Events.
Blood collection will occur at baseline and after completion of cardiac rehabilitation as per the Schedule of Events and will be timed to stay within Red Cross Guidelines (less than 480 mL every 8 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Cardiac Rehabilitation
Participants will undergo 12 weeks of standard of care cardiac rehabilitation.
干预措施: Cardiac Rehabilitation (Behavioral)
Control Arm
No intervention control group
结局指标
主要结局
Change in adjusted heart rate reserve
时间窗: Baseline and 12 weeks
Adjusted heart rate reserve (peak HR-rest HR)/(220-age-rest HR) achieved during symptom-limited maximal cardiopulmonary testing performed with cycle ergometer
Change in Peak VO2 (ml/kg/min)
时间窗: Baseline and 12 weeks
Peak VO2 measured with maximal symptom limited cardiopulmonary exercise testing
次要结局
- Change in Peak VO2 (percent predicted)(Baseline and 12 weeks)
- Number of Cardiac Rehabilitation sessions attended(12 weeks)
- Change in Proportion with peak VO2 less than 85% predicted(Baseline and 12 weeks)
- Change in Quality of life assessed with EuroQol (EQ-5D) Visual Analogue Scale(Baseline and 12 weeks)
- Change in Number of Long COVID symptoms(Baseline and 12 weeks)
- Change in Short Form Survey (SF-36) Score(Baseline and 12 weeks)
- Change in Inflammation(Baseline and 12 weeks)
- Net Promotor Score(12 weeks)
- Change in Composite Autonomic Symptom Scale-31 (Compass 31) Score(Baseline and 12 weeks)
- Change in Patient Health Questionnaire-9 (PHQ-9) Score(Baseline and 12 weeks)
- Change in Generalized Anxiety Disorder Screener (GAD-7) Score(Baseline and 12 weeks)