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Behavioural Intervention

Exercise for Post-COVID Syndrome

N/A

Recruiting

Led By Siddhartha S Angadi, PhD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-50 years of age

Diagnosed with Post Acute Sequelae of COVID-19

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Study Summary

This trial will explore if exercise can help improve symptoms of PASC, a multi-system disorder caused by COVID-19, in an effort to improve VO2peak, ventricular function, quality of life, exercise tolerance and PASC symptoms.

Who is the study for?

This trial is for adults aged 18-50 who have recovered from COVID-19 but are experiencing lingering effects known as Post-Acute Sequelae of COVID-19 (PASC). Participants must be fully vaccinated against COVID-19, have physician approval to exercise, and not suffer from severe health issues like uncontrolled hypertension or heart failure.Check my eligibility

What is being tested?

The study tests whether High-Intensity Interval Training (HIIT) or Moderate intensity exercise can improve symptoms and physical function in PASC patients. It's a randomized trial where participants will do either HIIT and MOD exercises or light stretching for four weeks to see if there's an improvement in their condition.See study design

What are the potential side effects?

Exercise programs generally may cause muscle soreness, fatigue, and shortness of breath especially when starting new routines. However, these side effects are typically temporary and often decrease with regular training.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 50 years old.

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I have long-term effects from COVID-19.

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I am fully vaccinated against COVID-19.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Left ventricular diastolic function

Left ventricular strain

VO2peak

Secondary outcome measures

C-reactive protein (CRP)

D-dimer

Erythrocyte sedimentation rate (ESR)

+13 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ExerciseExperimental Treatment1 Intervention

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 II: ControlActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise

2016

Completed Phase 1

~760

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

754 Previous Clinical Trials

1,245,045 Total Patients Enrolled

5 Trials studying COVID-19

10,129 Patients Enrolled for COVID-19

Siddhartha S Angadi, PhDPrincipal InvestigatorUniversity of Virginia

3 Previous Clinical Trials

125 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial include participants aged 40 and over?

"To be eligible for this research, participants must fall into the 18 to 50 age bracket. There are 101 studies available for minors and 674 trials designed specifically with elderly patients in mind."

Answered by AI

Is the research program currently recruiting new participants?

"Affirmative. The registry on ClinicalTrials.gov indicates enrollment is still open for this trial that was initially posted in September of 2023 and last edited in November of the same year. 28 individuals require recruitment at a single site."

Answered by AI

What is the intent of this research endeavor?

"The primary assessment of this 4-week trial is peak oxygen uptake (VO2peak). Secondary metrics include pre- and post-intervention spirometry Forced Vital Capacity, C Reactive Protein concentrations as a biomarker for inflammation, and an International Physical Activity Questionnaire to measure physical activity levels."

Answered by AI

What is the total enrolment number for this experiment?

"Affirmative. According to the information on clinicialtrials.gov, this research project is actively enlisting participants after being first posted on September 9th 2023 and recently updated November 27th 2023. 28 individuals are needed for participation at a single location."

Answered by AI

Is it possible for me to take part in this scientific experiment?

"This scientific experiment is only permitting a cohort of 28 individuals between the ages 18 and 50, suffering from Post Acute Sequelae (PAS) of COVID-19. Furthermore, patients must be immunized against the virus and receive medical clearance to partake in exercise training (as described on page 6)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Exercise Interventions in Post-acute Sequelae of Covid-19

Siddartha Angadi 2023. "Exercise Interventions in Post-acute Sequelae of Covid-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06065033.

All > Covid 19