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

48 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: People who are recovering from COVID-19 may continue to have problems that affect their daily life. For instance, they might feel overly tired. Researchers want to learn if exercise can help people recover after COVID-19 infection. Objective: To study if participation in a rehabilitation exercise program can help people recovering from COVID-19. Eligibility: Adults ages 18-80 with a lab-confirmed SARS-CoV2 infection (the virus that causes COVID-19), and are still having some symptoms. Design: Participants will have a medical history and physical exam. They will give blood and urine samples. They will have tests to measure heart and lung function. Their blood vessels will be assessed. Participants will have a computed tomography scan of the body. They will have an ultrasound of the muscles in their arms, legs, and chest. Participants will take a 6-minute walk test. They will take other balance and movement tests. Participants will walk on a treadmill while hooked up to a monitor. Then they will be interviewed. It will be audio-recorded. Participants will complete surveys about their symptoms and daily activities. Participants will take a smell test. For this, they will identify different smells. They will also have memory, attention, and mental functioning tests. Participants will wear an activity monitor on their wrist 24 hours a day. They will exercise 3 times a week for 10 weeks by moving vigorously on a track or treadmill for 30 minutes. They will attend education classes once a week for 10 weeks. Participants will be contacted by phone or email every 3 months for 1 year after they complete the exercise part of the study. They will wear an activity monitor for up to 2 weeks.

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.

What data supports the idea that Exercise for COVID-19 Recovery is an effective treatment?

The available research shows that Exercise for COVID-19 Recovery, which includes aerobic exercise, is effective in improving the independence and mobility of patients recovering from severe COVID-19. In one study, patients who participated in aerobic exercise as part of their rehabilitation program showed greater improvements in their ability to perform daily activities and walk independently compared to those who did not. Another study demonstrated that a comprehensive rehabilitation program, which included aerobic exercises, significantly improved lung function in COVID-19 patients. Additionally, a case report highlighted that home-based exercise training led to significant improvements in physical condition, strength, and reduction of symptoms in a COVID-19 survivor. These findings suggest that exercise is a beneficial treatment for enhancing recovery in COVID-19 patients. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Aerobic Exercise Training, Rehabilitation Exercise Program, and Graded Exercise Therapy (GET) for COVID-19 recovery?

Research shows that aerobic exercise and rehabilitation programs can improve independence, mobility, and lung function in COVID-19 patients. These treatments have been found to enhance physical capacity and reduce symptoms like fatigue, making them beneficial for recovery. ^{1 2 3 4 5}

What safety data exists for exercise in COVID-19 recovery?

The studies reviewed focus on aerobic exercise training in patients with chronic obstructive pulmonary disease (COPD), which may provide insights into safety for COVID-19 recovery. Aerobic exercise is generally considered safe for COPD patients, even during hospitalization for exacerbations, as it improves respiratory and muscle strength, increases activity tolerance, and reduces dyspnea. Vital signs such as blood pressure and respiratory rate may increase during exercise, but these changes are within safe limits. Exercise is recommended to improve quality of life and physical capacity, with attention to oxygen saturation, heart rate, and subjective symptoms. These findings suggest that aerobic exercise could be safe and beneficial for COVID-19 recovery, but specific studies on COVID-19 patients are needed for definitive safety data. ^{6 7 8 9 10}

Is aerobic exercise training generally safe for humans?

Research on aerobic exercise training, particularly in patients with chronic obstructive pulmonary disease (COPD), suggests it is generally safe. Studies show that it can be performed safely even in hospitalized patients, with careful monitoring of vital signs like blood pressure and oxygen levels. ^{6 7 8 9 10}

Is Aerobic Exercise Training a promising treatment for COVID-19 recovery?

Yes, Aerobic Exercise Training is a promising treatment for COVID-19 recovery. Studies show it can improve fitness, independence, and mobility in patients recovering from COVID-19. ^{2 11 12 13 14}

How does aerobic exercise training differ from other treatments for COVID-19 recovery?

Aerobic exercise training is unique for COVID-19 recovery as it focuses on improving physical fitness and mobility through structured exercise, which can enhance independence and quality of life. Unlike drug treatments, it involves physical activity to boost cardiovascular and respiratory health, making it a non-pharmacological option for rehabilitation. ^{2 11 12 13 14}

Research Team

Leighton Chan, M.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Eligibility Criteria

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

I performed above average in a 6-minute walk test for my age and gender.

Severe psychiatric disease, not responsive to treatment or medication

Pregnancy

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Benefits of Home-Based Exercise Training Following Critical SARS-CoV-2 Infection: A Case Report. [2022]

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

Effects of Aerobic Training in Patients with Subacute COVID-19: A Randomized Controlled Feasibility Trial. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Comprehensive Rehabilitation on Pulmonary Function in Patients Recovering from COVID-19. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Postacute inpatient rehabilitation for COVID-19. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Pulmonary recovery directly after COVID-19 and in Long-COVID. [2023]

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

Clinical effect of aerobic exercise training in chronic obstructive pulmonary disease: A retrospective study. [2023]

7. Egypt pubmed.ncbi.nlm.nih.gov

Assessment of Aerobic Exercise Adverse Effects during COPD Exacerbation Hospitalization. [2018]

8. Sweden pubmed.ncbi.nlm.nih.gov

[Persons with COPD should be recommended training]. [2017]

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

Older patients with COPD: benefits of exercise training. [2007]

10. England pubmed.ncbi.nlm.nih.gov

Exercise training improves recovery in patients with COPD after an acute exacerbation. [2019]

11. China pubmed.ncbi.nlm.nih.gov

Modified rehabilitation exercises for mild cases of COVID-19. [2020]

12. Switzerland pubmed.ncbi.nlm.nih.gov

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

13. France pubmed.ncbi.nlm.nih.gov

Rehabilitation in adult post-COVID-19 patients in post-acute care with Therapeutic Exercise. [2021]

14. Netherlands pubmed.ncbi.nlm.nih.gov

The role of exercise in rehabilitation of discharged COVID-19 patients. [2023]