48 Participants Needed

Exercise for COVID-19 Recovery

CR
LC
Overseen ByLeighton Chan, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: National Institutes of Health Clinical Center (CC)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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.12345

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.12345

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.678910

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.678910

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-19.211121314

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.211121314

Research Team

LC

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.
See 3 more

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
See 12 more

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
2Treatment groups
Experimental Treatment
Group I: Education only (CON)Experimental Treatment2 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 Treatment2 Interventions
Participants will perform both exercise training and education for 10 weeks

Find a Clinic Near You

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

References

Benefits of Home-Based Exercise Training Following Critical SARS-CoV-2 Infection: A Case Report. [2022]
Effects of Aerobic Training in Patients with Subacute COVID-19: A Randomized Controlled Feasibility Trial. [2023]
Effects of Comprehensive Rehabilitation on Pulmonary Function in Patients Recovering from COVID-19. [2023]
Postacute inpatient rehabilitation for COVID-19. [2020]
Pulmonary recovery directly after COVID-19 and in Long-COVID. [2023]
Clinical effect of aerobic exercise training in chronic obstructive pulmonary disease: A retrospective study. [2023]
Assessment of Aerobic Exercise Adverse Effects during COPD Exacerbation Hospitalization. [2018]
[Persons with COPD should be recommended training]. [2017]
Older patients with COPD: benefits of exercise training. [2007]
Exercise training improves recovery in patients with COPD after an acute exacerbation. [2019]
Modified rehabilitation exercises for mild cases of COVID-19. [2020]
Cardiopulmonary Rehabilitation in Long-COVID-19 Patients with Persistent Breathlessness and Fatigue: The COVID-Rehab Study. [2022]
Rehabilitation in adult post-COVID-19 patients in post-acute care with Therapeutic Exercise. [2021]
The role of exercise in rehabilitation of discharged COVID-19 patients. [2023]
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