Tele-Exercise Rehabilitation for COVID-19 Recovery

(BOOST Trial)

Overseen By Alice S Ryan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Myocardial infarction, Unstable angina, Severe heart failure, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The Coronavirus Disease 2019 (COVID-19) pandemic has resulted in catastrophic infections and fatalities across the nation. Many older Veterans with comorbidities are especially vulnerable to complications and poor recovery. This award will investigate the effect of a novel, home-based, supervised, group exercise tele-rehabilitation in Veterans recovered from COVID-19 on cardiopulmonary and physical function.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Tele-exercise Rehabilitation for COVID-19 Recovery?

Research shows that tele-rehabilitation, which includes supervised exercises done at home through video calls, can improve lung function and overall well-being in COVID-19 patients. Studies also indicate that such programs can reduce shortness of breath and improve the ability to perform daily tasks, making them a valuable option for recovery. ^{1 2 3 4 5}

Is tele-exercise rehabilitation safe for humans?

Research indicates that tele-exercise rehabilitation, also known as telerehabilitation, is generally safe for humans. Studies have shown low numbers of adverse events and high patient satisfaction, suggesting it is a safe option for rehabilitation, including for COVID-19 recovery. ^{6 7 8 9 10}

How is the Tele-exercise treatment for COVID-19 recovery different from other treatments?

Tele-exercise, or telerehabilitation, is unique because it allows COVID-19 patients to participate in rehabilitation programs remotely from their homes, overcoming barriers like transportation issues and the risk of contagion. This approach is particularly beneficial for those who cannot access in-person rehabilitation services, providing a safe and effective way to improve physical health and quality of life after COVID-19. ^{3 5 11 12 13}

Research Team

Alice S. Ryan, PhD

Principal Investigator

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Eligibility Criteria

This trial is for Veterans who had COVID-19 over 90 days ago, with a BMI over 30 and at least one comorbidity like hypertension or diabetes. It's not for those with recent heart attacks, uncontrolled health issues like severe diabetes or high blood pressure, or anyone already doing regular structured exercise.

Inclusion Criteria

You had COVID-19 more than 90 days ago and it was documented by a doctor.

I have been diagnosed with at least two of the following: high blood pressure, diabetes, heart disease, kidney disease, or COPD.

I have a diagnosed condition and my BMI is over 30.

Exclusion Criteria

I have had a heart attack in the last 3 months.

I am on dialysis for end-stage kidney failure.

I do not have severe heart failure (my heart's pumping ability is above 20% and I am not in advanced heart failure stages).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a home-based, supervised group exercise tele-rehabilitation program 2 times per week, focusing on aerobic and resistive training

12 weeks

Remote sessions via VA Video Connect

Follow-up

Participants are monitored for changes in cardiorespiratory fitness, pulmonary and physical function after the exercise program

4 weeks

Treatment Details

Interventions

• Tele-exercise

Trial Overview The study tests a home-based group exercise program delivered through tele-rehabilitation to improve cardiopulmonary and physical function in Veterans who have recovered from COVID-19.

Participant Groups

Group I: Tele-exercise Experimental Treatment 1 Intervention

Exercise training 2x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely.

Tele-exercise is already approved in United States, China, European Union for the following indications:

Approved in United States as Telerehabilitation for:

• Rehabilitation after COVID-19
• Cardiopulmonary rehabilitation
• Physical function improvement

Approved in China as Telerehabilitation for:

• Rehabilitation after COVID-19
• Pulmonary rehabilitation

Approved in European Union as Telerehabilitation for:

• Rehabilitation after COVID-19
• Cardiopulmonary rehabilitation
• Physical function improvement

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Baltimore VA Medical Center

Collaborator

Trials

33

Recruited

3,000+

Baltimore Veterans Affairs Medical Center

Collaborator

Trials

5

Recruited

470+

Salem Veterans Affairs Medical Center

Collaborator

Trials

6

Recruited

620+

Findings from Research

A home-based pulmonary rehabilitation program with telecoaching significantly improved social functioning and reduced daily-life dyspnea and exertional fatigue in COVID-19 survivors compared to a program without telecoaching.

Both groups showed overall improvements in pulmonary function and quality of life, but the telecoaching group experienced greater benefits, highlighting the potential value of remote support in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a home-based pulmonary rehabilitation program with and without telecoaching on health-related outcomes in COVID-19 survivors: a randomized controlled clinical study. Şahın, H., Naz, İ., Karadeniz, G., et al.[2023]

The study aimed to assess the feasibility of telerehabilitation (TR) for home exercises among older patients, but only 33 out of 333 screened patients met the criteria, and most withdrew due to exhaustion, indicating significant challenges in recruitment and retention.

Despite the difficulties faced in this study, the potential for TR to support older adults during recovery, especially during times like the COVID-19 pandemic, highlights the need for better recruitment strategies and user-friendly technology tailored for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A group-based real-time videoconferencing telerehabilitation programme in recently discharged geriatric patients: a feasibility study. Jørgensen, BB., Gregersen, M., Pallesen, SH., et al.[2022]

A telemedicine platform called 'COVIDREHAB' was developed and tested in a pilot study with 178 patients recovering from moderate COVID-19, showing that remote rehabilitation can effectively improve respiratory function and reduce symptoms like shortness of breath and feelings of lack of oxygen.

Patients who completed the COVIDREHAB program experienced significant improvements in their respiratory health, with shortness of breath severity decreasing from 34.8% to 12.4% and feelings of lack of oxygen from 32% to 17.4%, highlighting the efficacy of telemedicine in enhancing recovery during self-isolation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine platform COVIDREHAB for remote rehabilitation of patients after COVID-19. Gilmutdinova, IR., Kolyshenkov, VA., Lapickaya, KA., et al.[2022]

Telemonitoring and telerehabilitation significantly improved exercise capacity and health-related quality of life (HRQoL) in patients with chronic lung diseases or COVID-19, with 82% and 84% of studies reporting positive outcomes, respectively.

These interventions were found to be as effective as standard care, suggesting they are promising alternatives for supporting home-based rehabilitation in patients with chronic respiratory conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of telemonitoring and telerehabilitation on physical activity, exercise capacity, health-related quality of life and healthcare use in patients with chronic lung diseases or COVID-19: A scoping review. Sanchez-Ramirez, DC., Pol, M., Loewen, H., et al.[2022]

This study involves 122 COVID-19 survivors discharged from intensive care, comparing the effectiveness of supervised telerehabilitation to a home exercise program over 10 weeks, focusing on improvements in walking distance and overall physical health.

The primary goal is to determine if telerehabilitation can lead to greater improvements in walking distance and secondary outcomes like muscle strength and quality of life, which could provide a safe and effective rehabilitation alternative for patients facing transportation and contagion concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is tele-rehabilitation superior to home exercise program in COVID-19 survivors following discharge from intensive care unit? - A study protocol of a randomized controlled trial. Turan, Z., Topaloglu, M., Ozyemisci Taskiran, O.[2022]

Telerehabilitation for individuals with COVID-19 and post-COVID-19 conditions showed improvements in functional capacity, such as increased 6-minute walk distance and better performance on the 30-second sit-to-stand test, based on a systematic review of six trials involving 323 participants.

The intervention was found to be safe, with adverse events being mostly mild or moderate and occurring at similar rates in both telerehabilitation and control groups, suggesting that telerehabilitation does not significantly increase the risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation improves physical function and reduces dyspnoea in people with COVID-19 and post-COVID-19 conditions: a systematic review. Vieira, AGDS., Pinto, ACPN., Garcia, BMSP., et al.[2022]

Telerehabilitation for patients with respiratory tract diseases, including those with stable COPD and COVID-19, has been found to be safe and feasible, with low reported adverse events and over 70% adherence to sessions.

Most telerehabilitation programs focused on aerobic and muscle-strengthening exercises, suggesting that remote rehabilitation could effectively reduce the need for in-person therapy during the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation in Subjects With Respiratory Disease: A Scoping Review. Taito, S., Yamauchi, K., Kataoka, Y.[2023]

The pilot study involving 44 COVID-19 survivors showed that a fully remote telerehabilitation program was safe and feasible, with no serious adverse events reported and a high adherence rate of 93% among participants receiving the intervention.

Both the intervention and control groups experienced meaningful improvements in function and balance, indicating that while the telerehabilitation program was effective, further studies are needed to fully assess its efficacy compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, feasibility and initial efficacy of an app-facilitated telerehabilitation (AFTER) programme for COVID-19 survivors: a pilot randomised study. Capin, JJ., Jolley, SE., Morrow, M., et al.[2023]

A pilot program involving 16 patients showed that a COVID-19 telerehabilitation program, initiated in the hospital and continued at home using a mobile app, was feasible and safe, enhancing physical therapy engagement.

Patients reported high satisfaction with the telerehabilitation program (average score of 8.9) and the mobile app (average score of 8.4), with 63% preferring this method over traditional center-based rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes measures (PROMs) and patient-reported experience measures (PREMs) of COVID-19 telerehabilitation: Prospective pilot program. Bordas-Martinez, J., Matéu Gómez, L., Cámara Menoyo, D., et al.[2023]

A scoping review of 107 studies involving 3991 participants with stroke found that safety measures during asynchronous telerehabilitation exercises are rarely reported, with only 10 studies detailing such measures.

Common safety strategies included assessing exercise locations, using seated positions, and implementing live warning systems to prevent risky exercises, highlighting the need for more comprehensive reporting in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measures to ensure safety during telerehabilitation of people with stroke: A scoping review. Gutierrez-Arias, R., González-Mondaca, C., Marinkovic-Riffo, V., et al.[2023]

Home-based rehabilitation can effectively support patients recovering from severe COVID-19 and other conditions, especially when access to traditional rehabilitation centers is limited due to social distancing measures.

Success in home-based rehabilitation relies on patient engagement, therapy intensity, and the use of technology like telerehabilitation frameworks and robotic devices to monitor progress and provide support remotely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper Limb Home-Based Robotic Rehabilitation During COVID-19 Outbreak. Manjunatha, H., Pareek, S., Jujjavarapu, SS., et al.[2021]

A study involving 40 COVID-19 survivors demonstrated that pulmonary telerehabilitation significantly improved exercise capacity, with sit-to-stand repetitions increasing from 20 to 25 after the program, indicating enhanced physical recovery.

Participants also reported reduced breathlessness and improved quality of life, with scores on the Medical Research Council dyspnoea scale decreasing from 3.5 to 2, showcasing the efficacy of telerehabilitation in addressing respiratory symptoms and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group-based pulmonary telerehabilitation is feasible, safe, beneficial and well-received in patients who have been hospitalised with COVID-19. Simpson, AJ., Green, A., Nettleton, M., et al.[2023]

Pulmonary rehabilitation (PR) is crucial for improving symptoms and exercise tolerance in patients with chronic obstructive pulmonary disease (COPD), but the COVID-19 pandemic has severely disrupted traditional PR programs, leading to increased risks of physical deconditioning and social isolation among these vulnerable patients.

To adapt to the challenges posed by the pandemic, some PR programs have shifted to home-based telerehabilitation, but barriers such as technology access, lack of standardization, and insufficient training for healthcare professionals hinder effective implementation, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary Rehabilitation in a Post-COVID-19 World: Telerehabilitation as a New Standard in Patients with COPD. Tsutsui, M., Gerayeli, F., Sin, DD.[2021]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Effects of a home-based pulmonary rehabilitation program with and without telecoaching on health-related outcomes in COVID-19 survivors: a randomized controlled clinical study. [2023]

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

A group-based real-time videoconferencing telerehabilitation programme in recently discharged geriatric patients: a feasibility study. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Telemedicine platform COVIDREHAB for remote rehabilitation of patients after COVID-19. [2022]

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

Effect of telemonitoring and telerehabilitation on physical activity, exercise capacity, health-related quality of life and healthcare use in patients with chronic lung diseases or COVID-19: A scoping review. [2022]

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

Is tele-rehabilitation superior to home exercise program in COVID-19 survivors following discharge from intensive care unit? - A study protocol of a randomized controlled trial. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Telerehabilitation improves physical function and reduces dyspnoea in people with COVID-19 and post-COVID-19 conditions: a systematic review. [2022]

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

Telerehabilitation in Subjects With Respiratory Disease: A Scoping Review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Safety, feasibility and initial efficacy of an app-facilitated telerehabilitation (AFTER) programme for COVID-19 survivors: a pilot randomised study. [2023]

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

Patient-reported outcomes measures (PROMs) and patient-reported experience measures (PREMs) of COVID-19 telerehabilitation: Prospective pilot program. [2023]

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

Measures to ensure safety during telerehabilitation of people with stroke: A scoping review. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Upper Limb Home-Based Robotic Rehabilitation During COVID-19 Outbreak. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Group-based pulmonary telerehabilitation is feasible, safe, beneficial and well-received in patients who have been hospitalised with COVID-19. [2023]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Pulmonary Rehabilitation in a Post-COVID-19 World: Telerehabilitation as a New Standard in Patients with COPD. [2021]