Exercise as a Therapeutic for Those Diagnosed With Post-acute Sequelae of Covid-19
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- University of Virginia
- Locations
- 1
- Primary Endpoint
- Left ventricular diastolic function
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
The COVID-19 pandemic severely impacted the medical system both directly but also through incomplete recovery from the virus in the form of post-acute sequelae of COVID-19 (PASC). PASC affects at least 9.6 million individuals as of May 2022 and continues to affect many more. PASC is a multisystem disorder often presenting with mental fog, dyspnea on exertion, and fatigue among other symptoms. The etiology of PASC is uncertain but theories include direct cytotoxicity, dysregulated immune responses, endotheliitis associated with microthrombi, eNOS uncoupling, and myocardial fibrosis with impaired ventricular compliance. To date, there are no established treatments. Exercise has the potential as a therapeutic option to improve VO2peak and improve each of the aforementioned underlying etiologies. The investigators plan to examine the effect of High-Intensity Interval Training (HIIT) and Moderate intensity exercise training (MOD) on the symptoms and exercise tolerance of patients with PASC.
The investigators approach will consist of a randomized, blinded, 2-arm, parallel-group design. Enrolled subjects will be randomly assigned to one of two groups in a 1:1 allocation ratio. All groups will undergo a 4-week intervention of 3 days of HIIT per week and 2 days of MOD per week or control of light stretching and controlled breathing. Subjects will be assessed before and after the 4-week intervention to examine the extent to which 4 weeks of the HIIT and MOD combination improves VO2peak and left ventricular diastolic function, global longitudinal strain (GLS), and global circumferential strain (GCS). Further, the investigators will explore changes in markers such as heart rate, heart rhythm, blood pressure, quality of life, exercise tolerance, and PASC symptoms as well as blood/serum markers.
Investigators
Siddartha Angadi
Principal Investigator
University of Virginia
Eligibility Criteria
Inclusion Criteria
- •18-50 years of age
- •Diagnosed with Post Acute Sequelae of COVID-19
- •Physician clearance to undergo exercise training (see section titled cardiorespiratory fitness testing for details; page 6)
- •Complete COVID-19 vaccination status
Exclusion Criteria
- •Unstable angina or myocardial infarction in the past 4 weeks
- •Uncompensated heart failure
- •NYHA class IV symptoms
- •Complex ventricular arrhythmias
- •Musculoskeletal contraindications to stationary bicycling exercise
- •Symptomatic severe aortic stenosis
- •Acute pulmonary embolus
- •Acute myocarditis
- •Uncontrolled Hypertension as defined as systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 120 mm Hg
- •Medication non-compliance
Outcomes
Primary Outcomes
Left ventricular diastolic function
Time Frame: 4 weeks
Diastolic dysfunction grade measured pre- and post-intervention
VO2peak
Time Frame: 4 weeks
Change in VO2peak (L/min) measured pre- and post-intervention
Left ventricular strain
Time Frame: 4 weeks
Global longitudinal strain and global circumferential strain measured pre- and post-intervention
Secondary Outcomes
- Forced vital capacity (FVC)(4 weeks)
- C-reactive protein (CRP)(4 weeks)
- IL-1(4 weeks)
- TNF-a(4 weeks)
- Forced expiratory volume in one second (FEV1)(4 weeks)
- Post COVID-19 Functional Status scale(4 weeks)
- Fasting glucose(4 weeks)
- Symptom Burden Questionnaire for Long Covid (SBQ-LC)(4 weeks)
- Lipids(4 weeks)
- D-dimer(4 weeks)
- International Physical Activity Questionnaire (IPAQ)(4 weeks)
- IL-6(4 weeks)
- Fibrinogen(4 weeks)
- NTproBNP(4 weeks)
- Insulin(4 weeks)
- Erythrocyte sedimentation rate (ESR)(4 weeks)