Official Title
Physiological Underpinnings of Post-Acute Sequelae of SARS CoV-2 ("Long COVID") and Impact of Cardiopulmonary Rehabilitation on Quality-of-Life and Functional Capacity
Brief Summary

The primary objectives of this study are to establish exercise training as a novelintervention to treat Long COVID and characterize the cardiorespiratory and autonomicphysiology in these patients to precisely characterize mechanisms contributing to thissyndrome.

Detailed Description

Abnormalities observed among Long COVID patients are consistent with cardiac
deconditioning. The Long COVID syndrome has been attributed to dysautonomia and/or
postural orthostatic tachycardia syndrome (POTS) based largely on anecdotal experience
and observations of positional tachycardia among affected individuals. However, it has
been emphasized that data are clearly lacking to implicate dysautonomia alone as the
cause of Long COVID. Alternatively, cardiac deconditioning leads to a constellation of
symptoms, including exercise intolerance, brain fog/cognitive impairments, tachycardia
and orthostatic intolerance, all of which are reported among reported among patients with
Long COVID. Multiple studies have demonstrated that cardiac deconditioning may occur with
as little as 20 hours of bedrest. Exercise training improves cardiorespiratory
performance among patients suffering from cardiac deconditioning. Exercise training
improves HR regulation and cardiovascular function during submaximal and peak exercise,
and improves overall exercise capacity particularly among individuals with cardiac
deconditioning following bedrest (e.g. Dallas bedrest studies) and among individuals with
postural orthostatic tachycardia syndrome. Our preliminary data demonstrate a significant
improvement/resolution in Long-COVID symptoms following a twelve-week exercise training
program in a community setting. During the height of the COVID pandemic, the
investigators developed an exercise protocol that has been used in the clinical setting
to assist with management of patients suffering from Long COVID. This protocol involves
recumbent/semi-recumbent exercise - specifically, rowing or cycling on a recumbent
ergometer.

This proposal involves a clinical trial involving a two-aim initiative whereby
participants with Long COVID will be randomized to a 12-week period of exercise training
v. usual care ("controls") with baseline and follow-up assessments in order to: 1)
Establish exercise training as a novel treatment strategy for management of Long COVID
(Aim 1); and 2) Characterize cardiovascular/autonomic physiology among patients with Long
COVID (Aim 2).

There will be a total of 4 visits for testing.

- Baseline Evaluation

- Visit 1: non-invasive baseline assessment. Visit length ~2 hours.

- Visit 2: invasive baseline assessment. Visit length ~3 hours.

- Visit 3: non-invasive, post-exercise assessment. Protocol identical to Visit 1

- Visit 4: invasive, follow-up assessment. Protocol identical to Visit 2.

- Following completion of Visits 1 and 2, participants will be randomized in a 1:1
ratio to either: 1) Twelve weeks of exercise training (N=15); or 2) Twelve weeks of
conservative management (N=15). Thereafter, all participants will complete follow-up
evaluation with noninvasive assessment (Visit 3) and invasive assessment (Visit 4),
identical to the protocol for Visits 1-2.

Recruiting
Post-acute Sequelae of SARS-CoV-2 Infection

Behavioral: Exercise

exercise protocol

Eligibility Criteria

Inclusion Criteria:

- Adults ≥18 years with documented history of COVID-19 infection and symptoms
consistent with Long COVID lasting >4 weeks after diagnosis.

Exclusion Criteria:

- History of cardiovascular/pulmonary disease prior to infection

- COVID-related myocardial injury such as evidence of myocarditis

- Deep vein thrombosis/pulmonary embolism following COVID-19 infection

- Exercise intolerance resulting from conditions that are not related to
cardiorespiratory or autonomic factors (e.g. osteoarthritis or other musculoskeletal
diseases);

- Dependency of supplemental oxygen following COVID infection due to cardiovascular
and/or pulmonary complications following acute COVID infection

- body mass index > 35kg/m2

- age of greater than 65 years.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
United States
Locations

University of Colorado Hospital
Aurora, Colorado, United States

Investigator: William K Cornwell, III, MD

Contacts

William K Cornwell, III, MD
303-724-2085
william.cornwell@cuanschutz.edu

Not Provided

University of Colorado, Denver
NCT Number
Keywords
Cardiopulmonary Rehabilitation
long COVID
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome