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CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19 (CARE BEAR-LC)

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ClinicalTrials.gov Identifier: NCT05530317
Recruitment Status : Not yet recruiting
First Posted : September 7, 2022
Last Update Posted : September 7, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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).

Condition or disease Intervention/treatment Phase
Long COVID COVID-19 Behavioral: Cardiac Rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: pre- post-
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19 (CARE BEAR-LC): A Proof-of-Concept, Mechanistic Trial
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cardiac Rehabilitation
Participants will undergo 12 weeks of standard of care cardiac rehabilitation.
Behavioral: Cardiac Rehabilitation
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. 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. Participants are asked to commit to attending at least 24 sessions, of which 12 (one per week for 12 weeks) must be in person. Participants will be allowed to select a fully in-person approach (36 sessions) or hybrid approach (12-24 in person, 12-24 virtual for up to 36 total sessions).




Primary Outcome Measures :
  1. Change in adjusted heart rate reserve [ Time Frame: 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

  2. Change in Peak VO2 (ml/kg/min) [ Time Frame: Baseline and 12 weeks ]
    Peak VO2 measured with maximal symptom limited cardiopulmonary exercise testing


Secondary Outcome Measures :
  1. Change in Peak VO2 (percent predicted) [ Time Frame: Baseline and 12 weeks ]
    Peak VO2 (percent predicted using the Wasserman equations) measured with maximal symptom limited cardiopulmonary exercise testing

  2. Number of Cardiac Rehabilitation sessions attended [ Time Frame: 12 weeks ]
    Number of in person and virtual sessions attended by each participant

  3. Change in Proportion with peak VO2 less than 85% predicted [ Time Frame: Baseline and 12 weeks ]
    Proportion with peak VO2<85% predicted (using the Wasserman equations) measured with maximal symptom limited cardiopulmonary exercise testing

  4. Change in Number of Long COVID symptoms [ Time Frame: Baseline and 12 weeks ]
    Long COVID symptoms assessed using the LIINC symptom questionnaire (number of symptoms, more symptoms is worse).

  5. Change in Composite Autonomic Symptom Scale-31 (Compass 31) Score [ Time Frame: Baseline and 12 weeks ]
    Compass 31 summary score (0-100, with higher score indicating more severe autonomic symptoms).

  6. Change in Patient Health Questionnaire-9 (PHQ-9) Score [ Time Frame: Baseline and 12 weeks ]
    The PHQ-9 is a self-administered diagnostic instrument for depression. The PHQ-9 score ranges from 0 to 21, with higher scores indicating more severe depression.

  7. Change in Generalized Anxiety Disorder Screener (GAD-7) Score [ Time Frame: Baseline and 12 weeks ]
    The GAD-7 is a self-administered diagnostic instrument for depression. The GAD-7 score ranges from 0 to 27, with higher scores indicating more severe anxiety.

  8. Change in Short Form Survey (SF-36) Score [ Time Frame: Baseline and 12 weeks ]
    Overall quality of life using the short form health survey (SF-36). Scores range from 0-100 with higher scores representing a more favorable health state. The 36 questions are combined to form 8 scales in the domains of physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health.

  9. Change in Quality of life assessed with EuroQol (EQ-5D) Visual Analogue Scale [ Time Frame: Baseline and 12 weeks ]
    Quality of life on EQ-5D VAS (0-100, with 100 being the best).

  10. Change in flow mediated dilation of the brachial artery [ Time Frame: Baseline and 12 weeks ]
    Endothelial function assessed by change in brachial artery diameter in mm after administration of nitroglycerin compared to before administration of nitroglycerin

  11. Change in Inflammation [ Time Frame: Baseline and 12 weeks ]
    hsCRP (mg/L) is a marker of inflammation

  12. Net Promotor Score [ Time Frame: 12 weeks ]
    Would you recommend cardiac rehabilitation to your family/friends (1-10 scale). The percentage who report 0-6 ("detractors") is subtracted from the percentage who report 9 or 10 ("promotors") to calculate a "Net Promoter Score."



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <85% predicted and adjusted heart rate reserve achieved <80% on maximal CPET (RER>1.05). If there are difficulties with recruitment we may include individuals with exercise capacity between 85-99% predicted.
  5. Willing and able to actively participate in cardiac rehabilitation including attending at least 12 in person sessions at UCSF Parnassus.
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05530317


Contacts
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Contact: Matthew S Durstenfeld, MD MAS 628-206-5562 matthew.durstenfeld@ucsf.edu

Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94110
Contact: Matthew Durstenfeld, MD MAS    628-206-5562    matthew.durstenfeld@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Matthew S Durstenfeld, MD MAS University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05530317    
Other Study ID Numbers: 22-37106
First Posted: September 7, 2022    Key Record Dates
Last Update Posted: September 7, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
chronotropic incompetence
cardiac rehabilitation
cardiopulmonary exercise testing
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases