Exercise Interventions in Post-acute Sequelae of Covid-19

NCT06065033 | Withdrawn

• 1 other identifier: HSR230278
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (16)

• Forced expiratory volume in one second (FEV1)

  4 weeks

• Forced vital capacity (FVC)

  4 weeks

• Post COVID-19 Functional Status scale

  4 weeks

• Symptom Burden Questionnaire for Long Covid (SBQ-LC)

  4 weeks

• International Physical Activity Questionnaire (IPAQ)

  4 weeks

Study Arms (2)

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). * 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.

Behavioral: Exercise

Control

NO INTERVENTION

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

Interventions

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). * 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.

Exercise

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia University Hospital

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Siddhartha S Angadi, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to subject allocation
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Our approach will consist of a randomized, blinded, 2-arm, parallel-group design

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 3, 2023
• Study Start: September 9, 2023
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

US (1)