Exercise Program for Long COVID

(PASC Trial)

Overseen By Taylor Gilliland, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Disqualifiers: Severe hypertension, Metabolic disease, Uncontrolled asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

21 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

To examine the efficacy of an 8-week exercise training program on functional, cognitive, and emotional health outcomes compared to a no treatment control condition in adults with PASC.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to consult with the trial coordinators for more details.

What safety data exists for exercise programs in treating Long COVID?

Exercise programs for Long COVID have been generally well-tolerated with no reported adverse events in studies. They have shown benefits in improving symptoms like fatigue, dyspnea, and depression. However, caution is advised for patients with post-exertional malaise or chronic fatigue syndrome. Medical examinations and regular evaluations are recommended to ensure safety. More randomized controlled trials are needed to further investigate the safety and effectiveness of these interventions. ^{1 2 3 4 5}

Is exercise a promising treatment for Long COVID?

Yes, exercise is a promising treatment for Long COVID. Studies show that exercise can help improve symptoms like fatigue and shortness of breath. It can also boost overall physical function and quality of life for people with Long COVID. Exercise programs, especially those tailored to individual needs, have shown positive results in helping people manage their symptoms. ^{1 3 4 6 7}

What data supports the idea that Exercise Program for Long COVID is an effective treatment?

The available research shows that exercise programs can be effective for people with Long COVID. For example, a systematic review found that physical activity, especially exercises targeting respiratory function, can improve symptoms and physical function. Another study, the COVID-Rehab study, suggests that an eight-week exercise program can enhance fitness and quality of life for Long COVID patients. Additionally, exercise training has been shown to help with symptoms like fatigue and shortness of breath, which are common in Long COVID. Compared to other treatments, exercise programs are promising because they address multiple symptoms and improve overall health. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I have been diagnosed with COVID-19 before.

Exclusion Criteria

I had COVID-19 more than 6 months ago.

I have been diagnosed with claustrophobia.

I use extra oxygen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Training Program

Participants undergo an 8-week exercise training program with in-person and virtual sessions to improve functional, cognitive, and emotional health outcomes.

8 weeks

7 in-person weekly sessions, daily virtual sessions

Follow-up

Participants are monitored for maintenance effects and health outcomes after the exercise training program.

8 weeks

Long-term Monitoring

Continuous monitoring of heart rate variability, respiratory rate, strain, skin temperature, and sleep metrics using the WHOOP 4.0 device.

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Prescription

Trial Overview 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.

How Is the Trial Designed?

Group I: Exercise training program Experimental Treatment 1 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 program Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Sports Academy

Collaborator

Trials

2

Recruited

150+

Published Research Related to This Trial

Physical therapy, particularly involving physical activity, is crucial for managing long COVID symptoms and improving overall physical function, as highlighted by a systematic review of six studies.

Significant improvements were noted in studies lasting at least 6 weeks that included inspiratory muscle training exercises, suggesting a promising therapeutic approach for individuals suffering from long COVID.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long COVID and Physical Therapy: A Systematic Review. Sánchez-García, JC., Reinoso-Cobo, A., Piqueras-Sola, B., et al.[2023]

The COVID-Rehab study aims to evaluate the effectiveness of an eight-week cardiopulmonary rehabilitation program on improving cardiorespiratory fitness in 40 individuals suffering from long COVID-19, with assessments on various health aspects including quality of life and cognitive function.

This randomized clinical trial will compare a structured exercise program against a control group maintaining their usual habits, addressing the lack of specific rehabilitation guidelines for long COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiopulmonary Rehabilitation in Long-COVID-19 Patients with Persistent Breathlessness and Fatigue: The COVID-Rehab Study. Besnier, F., Bérubé, B., Malo, J., et al.[2022]

Long COVID affects 25-30% of individuals who have had SARS-CoV-2, leading to symptoms like fatigue and impaired functional capacity, highlighting the need for effective treatment strategies.

Tailored exercise prescriptions can help alleviate symptoms of Long COVID by addressing deconditioning caused by inactivity, suggesting that exercise may be a beneficial management approach for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and Treatment of Exercise Intolerance in Patients With Long COVID. Edward, JA., Peruri, A., Rudofker, E., et al.[2023]

Rehabilitation Centres play a crucial role in the recovery of COVID-19 patients, especially those suffering from long-COVID-19 syndrome, as recovery extends beyond just controlling pulmonary inflammation.

The review suggests that structured exercise training can significantly benefit post-COVID-19 patients by improving their immune response and reducing inflammation, leading to a proposed exercise protocol tailored to their unique clinical needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training in Post-COVID-19 Patients: The Need for a Multifactorial Protocol for a Multifactorial Pathophysiology. Cattadori, G., Di Marco, S., Baravelli, M., et al.[2022]

Exercise training and pulmonary rehabilitation (PR) have shown promise in improving functional exercise capacity and reducing symptoms like shortness of breath and fatigue in individuals with long COVID, based on a review of recent studies.

The review highlights the need for more rigorous scientific research to better understand the benefits of structured PR for those experiencing respiratory-related symptoms after COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Year in Review: Long COVID and Pulmonary Rehabilitation. Burnett, DM., Skinner, CE.[2023]

Exercise interventions for non-hospitalized individuals with Post COVID-19 Syndrome (PCS) have been shown to improve aerobic fitness, physical function, and reduce symptoms like dyspnea, fatigue, and depression, based on a review of seven studies involving 935 participants.

The exercise programs were well tolerated with no reported adverse events, but safety measures such as medical evaluations and monitoring individual responses are crucial, especially for patients with post-exertional malaise or chronic fatigue syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training in Non-Hospitalized Patients with Post-COVID-19 Syndrome-A Narrative Review. Sick, J., König, D.[2023]

A 3-day micro-choice based rehabilitation program for 78 long COVID patients was found to be safe, with no adverse events reported and a high completion rate of 97.4%.

Participants experienced significant improvements in fatigue, functional levels, and reduced sick leave and dyspnea at both 7-day and 3-month follow-ups, indicating the program's effectiveness in managing long COVID symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A safe and effective micro-choice based rehabilitation for patients with long COVID: results from a quasi-experimental study. Frisk, B., Jürgensen, M., Espehaug, B., et al.[2023]

The COVID-19 pandemic has led to a significant decline in physical activity, highlighting the need for physicians to actively promote exercise among patients.

Exercise referral schemes, which involve collaboration with qualified exercise professionals, can effectively support physicians in encouraging physical activity, helping to reduce physician burnout and combat patient inactivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of collaboration between medical and exercise professionals in addressing patient physical inactivity. Bray, NW., O'Brien, MW., Wong, MY., et al.[2023]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Long COVID and Physical Therapy: A Systematic Review. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Cardiopulmonary Rehabilitation in Long-COVID-19 Patients with Persistent Breathlessness and Fatigue: The COVID-Rehab Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Characteristics and Treatment of Exercise Intolerance in Patients With Long COVID. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise Training in Post-COVID-19 Patients: The Need for a Multifactorial Protocol for a Multifactorial Pathophysiology. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Year in Review: Long COVID and Pulmonary Rehabilitation. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise Training in Non-Hospitalized Patients with Post-COVID-19 Syndrome-A Narrative Review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A safe and effective micro-choice based rehabilitation for patients with long COVID: results from a quasi-experimental study. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

The importance of collaboration between medical and exercise professionals in addressing patient physical inactivity. [2023]