Clinical trial NCT06065033: Exercise Interventions in Post-acute Sequelae of Covid-19
Official title: Exercise as a Therapeutic for Those Diagnosed With Post-acute Sequelae of Covid-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID-19
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Our approach will consist of a randomized, blinded, 2-arm, parallel-group design
Primary purpose: SUPPORTIVE_CARE

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.


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
* Pregnant women-self reported
* COPD GOLD stage D
* Malignancy currently actively being treated
* Uncontrolled Asthma
* Uncompensated Cirrhosis of the Liver
* Chronic Kidney disease requiring dialysis therapy
* Symptomatic Anemia
* Hemoglobin \<7g/dL
* Poorly controlled diabetes or A1c\>9%
* BMI \>35kg/m2
* Pulmonary Hypertension stage IV
* Any condition requiring supplemental oxygen
* Multiple Sclerosis

Primary outcomes:
measure: VO2peak
timeFrame: 4 weeks
measure: Left ventricular strain
timeFrame: 4 weeks
measure: Left ventricular diastolic function
timeFrame: 4 weeks
Secondary outcomes:
measure: Forced expiratory volume in one second (FEV1)
timeFrame: 4 weeks
measure: Forced vital capacity (FVC)
timeFrame: 4 weeks
measure: Post COVID-19 Functional Status scale
timeFrame: 4 weeks
measure: Symptom Burden Questionnaire for Long Covid (SBQ-LC)
timeFrame: 4 weeks
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 4 weeks
measure: NTproBNP
timeFrame: 4 weeks
measure: C-reactive protein (CRP)
timeFrame: 4 weeks
measure: Lipids
timeFrame: 4 weeks
measure: Fasting glucose
timeFrame: 4 weeks
measure: Insulin
timeFrame: 4 weeks
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: 4 weeks
measure: IL-1
timeFrame: 4 weeks
measure: IL-6
timeFrame: 4 weeks
measure: TNF-a
timeFrame: 4 weeks
measure: Fibrinogen
timeFrame: 4 weeks
measure: D-dimer
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia University Hospital
state: Virginia
Study officials:
affiliation: University of Virginia
name: Siddhartha S Angadi, PhD
role: PRINCIPAL_INVESTIGATOR
References: