Exercise for COVID-19 Recovery

Overseen By Leighton Chan, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: National Institutes of Health Clinical Center (CC)

Must not be taking: Beta blockers, Antiretrovirals

Disqualifiers: Heart disease, Cancer, Stroke, Diabetes, 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: 10

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if exercise can aid recovery from COVID-19 by reducing lingering symptoms like fatigue. Researchers are testing a program where participants either engage in Aerobic Exercise Training (a structured exercise program) and attend education classes or attend only education classes for the first 10 weeks, then switch roles. Adults aged 18-80 who had COVID-19 and still experience symptoms like tiredness may qualify. Participants will undergo various health tests and exercise on a treadmill while being monitored. Additionally, they will wear an activity monitor and maintain contact for a year after the trial.

As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

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

The trial does not specify if you must stop taking your current medications. However, if you are on medications that influence exercise performance, like beta blockers or antiretroviral therapy, you may be excluded from participating.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes people on medications that would influence exercise performance, like beta blockers or antiretroviral therapy. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that aerobic exercise can be safe and beneficial for people recovering from COVID-19. One study found that a 5-week program of aerobic exercise, combined with breathing exercises, improved heart and lung health in participants, indicating the exercise was well-tolerated.

Another study discovered that individuals with post-COVID-19 symptoms, such as fatigue and shortness of breath, experienced improvement after supervised exercise sessions. This suggests that although some may initially find exercise challenging, it can have a positive effect without causing serious side effects.

These findings indicate that aerobic exercise is generally safe for those recovering from COVID-19. However, since experiences vary, individuals should pay attention to their bodies and consult a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using aerobic exercise training for COVID-19 recovery because it offers a non-pharmacological approach to enhance recovery. Unlike standard treatments that often involve medications targeting symptoms or the virus itself, aerobic exercise aims to improve physical health and respiratory function through increased cardiovascular activity. This approach leverages the body's natural ability to heal and strengthen itself, potentially leading to improved long-term outcomes without the side effects associated with drug therapies. Additionally, combining exercise with education empowers patients with knowledge about managing their recovery, which could lead to more sustainable health improvements.

What evidence suggests that this trial's treatments could be effective for COVID-19 recovery?

Research has shown that exercise programs can significantly aid people recovering from COVID-19. In this trial, participants will join different treatment arms. One group will receive Aerobic Exercise Training and Education, while another will start with Education only before adding exercise. Studies have found that these programs improve both physical and mental health. For instance, patients have performed better on the 6-minute walk test, which measures endurance by assessing how far one can walk in six minutes. Exercise also strengthens the heart and lungs, making it easier for recovering patients to breathe and move. Overall, these exercises enhance quality of life by reducing shortness of breath and increasing the ability to perform everyday activities. ^{5 6 7 8 9}

Who Is on the Research Team?

Leighton Chan, M.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Are You a Good Fit for This Trial?

Adults aged 18-80 who had COVID-19 and are still experiencing symptoms like fatigue or physical limitations can join. They must understand English or Spanish, agree to the study's procedures, and have confirmed past infection with lab tests. People with severe psychiatric issues, certain medical conditions, extreme obesity (BMI > 40), or on conflicting medications cannot participate.

Inclusion Criteria

I can read, speak, and understand English or Spanish.

I don't experience severe fatigue after physical activity.

I had COVID-19 confirmed by a test or doctor at least 4 weeks ago.

Exclusion Criteria

Severe psychiatric disease, not responsive to treatment or medication

Pregnancy

Ongoing tobacco and/or nicotine product use

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo medical history, physical exam, and various tests including heart and lung function, blood vessel assessment, and muscle ultrasound

1-2 weeks

Multiple visits (in-person)

Treatment

Participants engage in aerobic exercise training and education for 10 weeks, with assessments of physical function and health-related quality of life

10 weeks

3 exercise sessions per week, 1 education class per week

Crossover Treatment

Participants in the control group crossover to perform aerobic exercise training for 10 weeks

10 weeks

3 exercise sessions per week

Follow-up

Participants are monitored for free-living physical activity, sleep quality, and health-related quality of life every 3 months for 1 year

1 year

Contacted by phone or email every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Exercise Training
• Education

Trial Overview The trial is testing if a rehabilitation exercise program helps recovery from COVID-19. Participants will do aerobic exercises three times a week for ten weeks and attend educational classes. They'll also be monitored through various health tests including heart and lung function, muscle ultrasounds, walking tests, surveys about their daily activities, smell tests, and mental functioning exams.

How Is the Trial Designed?

Group I: Education only (CON) Experimental Treatment 2 Interventions

Participants will perform only education for the first 10 weeks, then cross-over to perform exercise in the second 10 weeks

Group II: Aerobic Exercise Training and Education (AET+) Experimental Treatment 2 Interventions

Participants will perform both exercise training and education for 10 weeks

Who Is Running the Clinical Trial?

National Institutes of Health Clinical Center (CC)

Lead Sponsor

Trials

391

Recruited

30,880,000+

Published Research Related to This Trial

SARS-CoV-2 infection can lead to severe complications like pneumonia, pulmonary fibrosis, and multiorgan damage, even after the virus is no longer detectable in patients.

The health status of recovered COVID-19 patients is a growing concern, prompting the need for effective exercise rehabilitation programs to aid recovery and address potential long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of exercise in rehabilitation of discharged COVID-19 patients. Bo, W., Xi, Y., Tian, Z.[2023]

A study involving 60 mild COVID-19 patients showed that modified rehabilitation exercises significantly improved respiratory symptoms over time, indicating their efficacy in enhancing pulmonary function and easing expectoration.

The integration of acupressure with these exercises further supports recovery, making the modified rehabilitation exercises a recommended approach for managing respiratory issues in mild COVID-19 cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified rehabilitation exercises for mild cases of COVID-19. Zha, L., Xu, X., Wang, D., et al.[2020]

A randomized controlled trial involving 32 patients with severe or critical COVID-19 sequelae demonstrated that adding low- to moderate-intensity aerobic exercise to standard rehabilitation is both feasible and safe, with a high attendance rate of 95.6%.

The experimental group that included aerobic training showed significantly greater improvements in functional independence and mobility compared to the standard rehabilitation group, indicating that aerobic exercise can enhance recovery in patients with subacute COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Aerobic Training in Patients with Subacute COVID-19: A Randomized Controlled Feasibility Trial. Corna, S., Giardini, M., Godi, M., et al.[2023]

Individuals with chronic obstructive pulmonary disease (COPD) should engage in both aerobic and resistance training to enhance their quality of life, physical capacity, and reduce symptoms like dyspnoea, anxiety, and depression, supported by moderately strong evidence from the research.

During COPD exacerbations, low-intensity training is recommended to improve quality of life and physical capacity, and while evidence is limited, it may also help lower the risk of mortality and hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Persons with COPD should be recommended training]. Emtner, M., Wadell, K.[2017]

A 10-week home-based exercise training (HBET) program significantly improved the cardiorespiratory and physical functionality of a 67-year-old woman who had critical COVID-19, with VO2peak increasing by 45.9% and handgrip strength improving by 22.7%.

The HBET program was safe and led to reductions in fatigue and self-reported persistent symptoms, indicating its potential as an effective rehabilitation strategy for COVID-19 survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of Home-Based Exercise Training Following Critical SARS-CoV-2 Infection: A Case Report. Longobardi, I., do Prado, DML., Goessler, KF., 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]

Patients recovering from COVID-19, whether shortly after infection or long after (4-20 months), commonly experience pulmonary issues such as diaphragm dysfunction and dysfunctional breathing patterns, highlighting the need for diagnostic awareness.

A specialized rehabilitation program that includes respiratory therapy, muscular training, and psychological support significantly improves pulmonary recovery and helps most patients return to work, demonstrating its efficacy for both immediate and long-term post-COVID care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary recovery directly after COVID-19 and in Long-COVID. Altmann, CH., Zvonova, E., Richter, L., et al.[2023]

A 30-minute daily multi-component therapeutic exercise program significantly improved physical performance in 33 post-COVID-19 patients, including those who had been admitted to the ICU, with all measured outcomes showing significant improvement (p<0.01).

Patients who had been in the ICU experienced greater gains in physical performance, particularly in the Short Physical Performance Battery and gait speed, compared to those who did not require ICU care, highlighting the effectiveness of targeted rehabilitation strategies for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation in adult post-COVID-19 patients in post-acute care with Therapeutic Exercise. Udina, C., Ars, J., Morandi, A., et al.[2021]

In a study of 156 stable COPD patients, those who participated in aerobic exercise training showed a significantly lower acute incidence rate of 7.6% compared to 20.7% in the education-only group, indicating better overall health outcomes.

The aerobic exercise training group also demonstrated improved physical performance (measured by 6-minute walking distance), better lung function, enhanced T lymphocyte immune response, and reduced symptoms (lower CAT and mMRC scores), highlighting the efficacy of aerobic exercise in managing COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effect of aerobic exercise training in chronic obstructive pulmonary disease: A retrospective study. Zeng, Q., Liao, W., Fang, W., et al.[2023]

Aerobic exercise initiated 72 hours after hospitalization in 11 patients with exacerbated COPD was found to be safe, with significant increases in systolic blood pressure and respiratory rate during the activity.

Despite a decrease in oxygen saturation levels during exercise, the overall vital signs indicated that patients could tolerate the intensity, reaching an average of 76% of their maximum heart rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Aerobic Exercise Adverse Effects during COPD Exacerbation Hospitalization. Knaut, C., Mesquita, CB., Caram, LM., et al.[2018]

Aerobic exercise training (EXT) is beneficial for older adults with advanced chronic obstructive pulmonary disease (COPD), leading to significant reductions in breathlessness and improvements in exercise capacity and psychosocial function.

An 8-week outpatient program that includes individualized training and education is recommended for COPD patients, even those who are severely affected, to enhance their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older patients with COPD: benefits of exercise training. O'Donnell, DE., Webb, KA., McGuire, MA.[2007]

In a study of 29 patients with severe COPD, those who participated in a structured exercise program significantly improved their 6-minute walking distance from 237 to 420 meters, compared to only a slight increase in the control group (from 230 to 255 meters).

The exercise training also led to improvements in lung function and reduced breathing effort, as indicated by decreased minute ventilation and oxygen uptake at the same workload, highlighting the efficacy of exercise in enhancing recovery after an acute exacerbation of COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training improves recovery in patients with COPD after an acute exacerbation. Kirsten, DK., Taube, C., Lehnigk, B., et al.[2019]

In a study of 150 patients recovering from COVID-19, inpatient rehabilitation significantly improved lung function, as measured by spirometry, indicating its effectiveness in aiding recovery from lung-related complications of the virus.

The rehabilitation program, which included aerobic, strength, and endurance exercises, showed long-term benefits in lung function, and improvements were also associated with the patients' body mass index (BMI).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Comprehensive Rehabilitation on Pulmonary Function in Patients Recovering from COVID-19. Mińko, A., Turoń-Skrzypińska, A., Rył, A., et al.[2023]

A female patient in her early 80s with acute respiratory distress syndrome from COVID-19 showed significant improvement in mobility and endurance after 10 days of pulmonary rehabilitation, progressing from using a walker to ambulating without assistance.

The rehabilitation program effectively enhanced her functional exercise capacity, as evidenced by increased walking distance, improved heart rate, oxygen saturation, and lung function, highlighting the importance of pulmonary rehabilitation in recovery from COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postacute inpatient rehabilitation for COVID-19. Shan, MX., Tran, YM., Vu, KT., et al.[2020]

Citations

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The effect of exercise rehabilitation on COVID-19 outcomes Overall, both physical and psychological related outcomes have improved by exercise rehabilitation. The results are contrary to that of Connoly ...

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Aerobic Exercise in People With Post-COVID-19 The primary aim of this study is to study the feasibility of an aerobic training, in addition to conventional rehabilitation, in patients post sequela of ...