CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19

NCT05530317 | Recruiting

• 1 other identifier: 22-37106
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Long COVID; COVID-19

Keywords

chronotropic incompetence; cardiac rehabilitation; cardiopulmonary exercise testing

Outcome Measures

Primary Outcomes (2)

• Change in adjusted heart rate reserve

  Adjusted heart rate reserve (peak HR-rest HR)/(220-age-rest HR) achieved during symptom-limited maximal cardiopulmonary testing performed with cycle ergometer

  Baseline and 12 weeks

• Change in Peak VO2 (ml/kg/min)

  Peak VO2 measured with maximal symptom limited cardiopulmonary exercise testing

  Baseline and 12 weeks

Secondary Outcomes (11)

• 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 Number of Long COVID symptoms

  Baseline and 12 weeks

• Change in Composite Autonomic Symptom Scale-31 (Compass 31) Score

  Baseline and 12 weeks

Study Arms (2)

Cardiac Rehabilitation

EXPERIMENTAL

Participants will undergo 12 weeks of standard of care cardiac rehabilitation.

Behavioral: Cardiac Rehabilitation

Control Arm

NO INTERVENTION

No intervention control group

Interventions

Cardiac Rehabilitation BEHAVIORAL

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 with special attention to post-exertional malaise. 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. Most participants will participate in a hybrid approach (12-16 sessions in person), but participants will be allowed to select a fully in-person approach (36 sessions).

Cardiac Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Matthew S Durstenfeld, MD MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew S Durstenfeld, MD MAS

CONTACT

628-206-5562; matthew.durstenfeld@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pre- post-

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: December 21, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)