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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05530317
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).

Study Details

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).

Key Dates

Start date
Dec 21, 2022
Status verified
Mar 2025
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cardiac Rehabilitation
    Participants will undergo 12 weeks of standard of care cardiac rehabilitation.
  • No Intervention: Control Arm
    No intervention control group

Primary Outcome Measure

Change in adjusted heart rate reserve [ Time Frame: Baseline and 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94110
Matthew Durstenfeld, MD MAS
[email protected]
628-206-5562

Find similar trials in San Francisco, CA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
University of California, San Francisco· San Francisco, CA

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