MedTrace Logo

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

NCT05530317 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-02

No results posted yet for this study

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

Interventions

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 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).

Sponsors & Collaborators

Principal Investigators

  • Matthew S Durstenfeld, MD MAS · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-21
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05530317 on ClinicalTrials.gov