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Exercise Program for Long COVID (PASC Trial)

N/A

Recruiting

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

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

Must have

Self-reported ongoing symptoms of PASC >4 weeks after initial infection

Self-reported history of COVID-19 diagnosis

Must not have

Patient reported diagnosis of claustrophobia

Patient reported supplemental O2 use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up lasting 26 weeks.

Summary

This trial will test whether an 8-week exercise program can improve functional, cognitive, and emotional health outcomes in adults with PASC.

Who is the study for?

This trial is for adults aged 18-65 who have had COVID-19 and are experiencing ongoing symptoms more than 4 weeks after their initial infection. It's not suitable for those with exercise contraindications, severe hypertension, certain chronic diseases, or conditions that worsen with exercise. Pregnant individuals, inmates, non-English speakers, and those without access to an iOS device cannot participate.

What is being tested?

The study is testing the effectiveness of an 8-week guided exercise program on improving functional capacity, cognitive function, and emotional well-being in adults suffering from long-term COVID-19 effects compared to a group that does not receive any treatment.

What are the potential side effects?

Since this trial involves an exercise program rather than medication or medical procedures, side effects may include typical post-exercise symptoms such as muscle soreness or fatigue. However specific side effects will depend on individual health status.

Eligibility Criteria

Inclusion Criteria

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

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I have had long COVID symptoms for more than 4 weeks.

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I have been diagnosed with COVID-19 before.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with claustrophobia.

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I use extra oxygen.

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I have asthma that is not well-controlled.

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I have been told I have severe high blood pressure.

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I have a condition worsened by exercise or that stops me from exercising.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ lasting 26 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~lasting 26 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and lasting 26 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Peak Oxygen Consumption (VO2max), mL/min

Score on Cognitive Function Self-Assessment Scale (CFSS)

Score on PHQ-8

Secondary study objectives

Anxiety (GAD-7)

Breathing Reserve, %

Breathlessness (mMRC)

+40 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Exercise training programExperimental Treatment1 Intervention

Participants in this arm will complete an 8-week exercise training program comprised of an initial functional assessment to create an exercise prescription, followed by 7 in-person weekly sessions. Each session consisting of approximately 50 minutes of individualized exercise training and approximately 10 minutes of cognitive training via the Sports Academy "CogPT" iPad app. All participants will receive exercise and cognitive training delivered weekly in a group-based setting at Sports Academy within the Star in Frisco, Texas during the intervention period. Additionally, they will have access to daily workouts pushed to their phone via the MOVE exercise app developed by our team.

Group II: No training programPlacebo Group1 Intervention

Participants in this arm will be wearing the WHOOP band for 8-weeks but will not be exposed to any active intervention.

0 / 8Eligibility criteria met