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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Patients will perform 5 days of supervised stationary cycling exercise (with EKG telemetry) per week over a period of 4 weeks. Training heart rates will be determined based on the pre-testing VO2peak and peak heart rate (PHR).
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| Control | No Intervention | The control protocol will include a combination of light stretching and controlled breathing. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Patients will perform 5 days of supervised stationary cycling exercise (with EKG telemetry) per week over a period of 4 weeks. Training heart rates will be determined based on the pre-testing VO2peak and peak heart rate (PHR).
|
| Measure | Description | Time Frame |
|---|---|---|
| VO2peak | Change in VO2peak (L/min) measured pre- and post-intervention | 4 weeks |
| Left ventricular strain | Global longitudinal strain and global circumferential strain measured pre- and post-intervention | 4 weeks |
| Left ventricular diastolic function | Diastolic dysfunction grade measured pre- and post-intervention | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in one second (FEV1) | FEV1 measured via spirometry pre- and post-intervention | 4 weeks |
| Forced vital capacity (FVC) | FVC measured via spirometry pre- and post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siddhartha S Angadi, PhD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia University Hospital | Charlottesville | Virginia | 22903 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Our approach will consist of a randomized, blinded, 2-arm, parallel-group design
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Outcome assessors will be blinded to subject allocation
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| 4 weeks |
| Post COVID-19 Functional Status scale | Measures subjects functional limitations due to COVID-19 and will be measured via pre- and post-intervention | 4 weeks |
| Symptom Burden Questionnaire for Long Covid (SBQ-LC) | Burden of symptoms will be via the SBQ-LC measured pre- and post-intervention | 4 weeks |
| International Physical Activity Questionnaire (IPAQ) | Physical activity levels will be assessed via IPAQ measured pre- and post-intervention | 4 weeks |
| NTproBNP | Assess changes in NTproBNP (pg/ml) as a biomarker of myocardial strain at pre- and post-intervention | 4 weeks |
| C-reactive protein (CRP) | C-reactive protein (mg/dl) will be used as a biomarker for inflammation to be measured pre- and post-intervention | 4 weeks |
| Lipids | A lipid panel will be performed to measure total cholesterol, triglycerides, high-density lipoproteins, and low-density lipoprotein (mg/dl) to assess changes in cardiometabolic health pre- and post-intervention | 4 weeks |
| Fasting glucose | Fasting blood glucose levels (mg/dl) will be tested to assess changes in cardiometabolic health pre- and post-intervention | 4 weeks |
| Insulin | Fasting insulin levels (U/ml) will be tested to assess changes in cardiometabolic health pre- and post-intervention | 4 weeks |
| Erythrocyte sedimentation rate (ESR) | ESR will be measured to assess inflammation pre- and post-intervention | 4 weeks |
| IL-1 | Inflammation will be measured via IL-1 pre- and post-intervention | 4 weeks |
| IL-6 | Inflammation will be measured via IL-6 pre- and post-intervention | 4 weeks |
| TNF-a | Inflammation will be measured via TNF-a pre- and post-intervention | 4 weeks |
| Fibrinogen | Fibrinogen will be measured pre- and post-intervention to measure clotting | 4 weeks |
| D-dimer | D-dimer will be measured pre- and post-intervention to measure clotting | 4 weeks |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |