Exercise Interventions in Post-acute Sequelae of Covid-19

NCT ID: NCT06065033

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-09
• Study Completion Date: 2024-03-29

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Exercise

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).

• Of the 5 sessions, 3 will be HIIT sessions and 2 will be MOD sessions.
• Subjects exercising on the HIIT day will start with eight intervals of 2-min duration at 80-85% of PHR, separated by 2 min of recovery at 50% of PHR, progressing to four, 4-min intervals at 90-95% PHR, separated by 3 min at 50% PHR by the end of week 2.
• Subjects exercising on the MOD days will perform uninterrupted for 40 minutes duration at 60-65% of PHR progressing to 40 minutes duration at 70-75% of PHR by the end of week 2.
• Each training session will begin with a 10-min warm-up at 50% PHR and end with a 5-min cool down at 50% PHR. Exercise progression may have to be modified according to individual subject exercise tolerance.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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).

• Of the 5 sessions, 3 will be HIIT sessions and 2 will be MOD sessions.
• Subjects exercising on the HIIT day will start with eight intervals of 2-min duration at 80-85% of PHR, separated by 2 min of recovery at 50% of PHR, progressing to four, 4-min intervals at 90-95% PHR, separated by 3 min at 50% PHR by the end of week 2.
• Subjects exercising on the MOD days will perform uninterrupted for 40 minutes duration at 60-65% of PHR progressing to 40 minutes duration at 70-75% of PHR by the end of week 2.
• Each training session will begin with a 10-min warm-up at 50% PHR and end with a 5-min cool down at 50% PHR. Exercise progression may have to be modified according to individual subject exercise tolerance.

Control

The control protocol will include a combination of light stretching and controlled breathing.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

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).

• Of the 5 sessions, 3 will be HIIT sessions and 2 will be MOD sessions.
• Subjects exercising on the HIIT day will start with eight intervals of 2-min duration at 80-85% of PHR, separated by 2 min of recovery at 50% of PHR, progressing to four, 4-min intervals at 90-95% PHR, separated by 3 min at 50% PHR by the end of week 2.
• Subjects exercising on the MOD days will perform uninterrupted for 40 minutes duration at 60-65% of PHR progressing to 40 minutes duration at 70-75% of PHR by the end of week 2.
• Each training session will begin with a 10-min warm-up at 50% PHR and end with a 5-min cool down at 50% PHR. Exercise progression may have to be modified according to individual subject exercise tolerance.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Siddartha Angadi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Siddhartha S Angadi, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia University Hospital

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

HSR230278

Identifier Type: -

Identifier Source: org_study_id