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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an 8-week exercise program (Exercise Prescription) can improve physical, mental, and emotional health in individuals with Long COVID symptoms. Participants will either join a weekly group exercise and cognitive training session or wear a monitoring band without engaging in exercise. It suits adults who have had COVID-19 and continue to experience symptoms more than four weeks after their initial infection. As an unphased trial, this study provides a unique opportunity to contribute to understanding and potentially enhancing Long COVID recovery strategies.

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 prior data suggests that this exercise program is safe for adults with PASC?

Research shows that exercise programs can be safe and well-tolerated for people with long COVID. A review of studies found that exercise might help improve symptoms for some individuals dealing with long-term effects after COVID-19. Another study highlighted that exercise can improve various health outcomes without major safety concerns.

Participants with long COVID have engaged in these exercise programs, and most reported benefits without serious side effects. This suggests that an exercise plan, like the one in this trial, could be a safe option for managing long COVID symptoms. However, those considering joining a trial should consult a healthcare professional to ensure it's the right choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores an innovative approach for managing Long COVID through a structured exercise program. Unlike traditional treatments that might focus on medication or symptom management, this program combines physical exercise with cognitive training to potentially improve overall function and quality of life. The unique aspect of this method is its integration of personalized exercise plans with cognitive exercises using the Sports Academy CogPT app, delivered in a supportive, group-based setting. This comprehensive approach aims to address both physical and cognitive symptoms, offering a holistic treatment option that could stand out from existing care practices.

What evidence suggests that this exercise program is effective for Long COVID?

Research has shown that exercise programs can help people with long COVID. Studies have found that exercise improves physical abilities and is generally well-tolerated by those with ongoing COVID-19 symptoms. In this trial, participants in the exercise training program arm will complete an 8-week exercise program, which may benefit physical, mental, and emotional health. Reviews of current evidence suggest that regular exercise can help manage symptoms and improve overall well-being in individuals with long COVID. ^{2 3 4 5 6}

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

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05218174

Exercise in Adults with Post-Acute Sequelae of SARS-CoV ... To examine the efficacy of an 8-week exercise training program on functional, cognitive, and emotional health outcomes compared to a no treatment control ...

2. bmjopen.bmj.com bmjopen.bmj.com/content/15/3/e082441

Effectiveness and tolerance of exercise interventions for ... Available evidence suggests that exercise interventions may be beneficial and tolerable among some people with long COVID.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40122540/

a systematic review of randomised controlled trials Available evidence suggests that exercise interventions may be beneficial and tolerable among some people with long COVID.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9821682/

Post-Acute Sequelae of COVID-19: The Potential Role of ... This review aims to summarise the current evidence about the PASC syndrome and the benefit of exercise in these patients and to provide a practical guide.

5. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001348

Exercise Intolerance and Response to Training in Patients ... The postacute sequelae of SARS-CoV-2, also known as Long COVID, may affect 10% to 25% of individuals diagnosed with SARS-CoV-2.

6. sciencedirect.com sciencedirect.com/science/article/pii/S258953702500344X

Effects of therapeutic interventions on long COVID: a meta- ... Primary outcomes included cardiopulmonary function, exercise capacity, fatigue, and olfactory recovery. Data were pooled using random-effects models, with ...