Pulmonary Rehabilitation for Post-COVID Syndrome

(LC Rehab Trial)

Overseen By William W Stringer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Must not be taking: Investigational drugs, systemic corticosteroids

Disqualifiers: Pregnancy, Malignancy, HIV, 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: 10

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an exercise and pulmonary rehab program can assist individuals with Long COVID-19. It examines the program's effects on physical health, immune response, and mental well-being. Participants will join either online (Virtual Pulmonary Rehabilitation) or in-person sessions to determine which method is more effective. Individuals who have experienced Long COVID for at least 12 weeks and have symptoms like fatigue or difficulty breathing may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding effective recovery methods for Long COVID.

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking an investigational drug, you must stop at least one month or six half-lives before the screening visit. Also, certain conditions like insulin or testosterone therapy, systemic corticosteroids, or HIV may affect your eligibility.

What prior data suggests that this pulmonary rehabilitation program is safe for patients with Long COVID-19?

Research shows that both virtual and in-person lung rehabilitation are safe treatments for people with Long COVID. Studies have found that virtual lung rehabilitation, where exercises occur through video, is practical and well-liked by participants. This method is safe, with no major side effects reported.

Similarly, in-person lung rehabilitation is also safe for those with Long COVID. Research indicates it effectively improves physical ability and lung function without causing harm. It also helps reduce long-lasting symptoms in patients.

In summary, both virtual and in-person lung rehabilitation are safe options according to research. Participants generally handle them well, making them promising treatments for managing Long COVID symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the pulmonary rehabilitation methods for post-COVID syndrome because they're exploring both virtual and on-site exercise programs. Unlike traditional rehabilitation, which usually requires patients to visit a clinic, the virtual option offers the flexibility of exercising from home. This approach can make it more accessible for people who have difficulty traveling or who live far from treatment centers. Additionally, by tailoring the intensity of exercises to accommodate patients with post-exertional malaise (PEM), the trial aims to create a more customized and potentially more effective rehabilitation experience.

What evidence suggests that Virtual vs On Site Pulmonary Rehabilitation is effective for Long COVID-19?

This trial will compare virtual pulmonary rehabilitation with on-site pulmonary rehabilitation for individuals with post-COVID syndrome. Research has shown that pulmonary rehabilitation aids those with long COVID. Studies indicate that virtual rehab can safely enhance physical abilities in COVID-19 recovery. Participants in virtual rehab often experience improved exercise capacity and lung function. Similarly, on-site pulmonary rehabilitation has proven effective, enhancing physical abilities, lung function, and quality of life while reducing symptoms like tiredness and anxiety. Both methods offer benefits, helping individuals feel and function better after COVID-19. ^{1 2 6 7 8}

Who Is on the Research Team?

William W Stringer, MD

Principal Investigator

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Are You a Good Fit for This Trial?

Adults who've had COVID-19 at least 12 weeks ago and are experiencing Long Haul COVID with symptoms like fatigue, difficulty breathing, or exercise intolerance. They must be able to do a cardiopulmonary test. Excluded are those in other studies, recently on investigational drugs, unable to perform certain tests, severely desaturating during exercise testing, pregnant/nursing women, recent cancer treatments or significant other diseases.

Inclusion Criteria

I experience fatigue, shortness of breath, or difficulty exercising.

I experience fatigue, shortness of breath, or difficulty exercising.

It has been over 12 weeks since I first had COVID-19.

Exclusion Criteria

You are unable to do breathing and exercise tests properly.

Your oxygen levels drop below 80% during exercise tests.

I don't have any major health issues that could affect my study participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 10-week rehabilitation program, either traditional pulmonary or virtual, based on their Post Exertional Malaise (PEM) status

10 weeks

10 visits (virtual or in-person depending on group)

Follow-up

Participants are monitored for changes in aerobic capacity, anxiety, sleep quality, quality of life, fatigue, dyspnea, post-exertional malaise, depression, and inflammatory markers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual vs On Site Pulmonary Rehabilitation

Trial Overview The study is comparing the effects of virtual versus on-site pulmonary rehabilitation programs for Long Haul COVID patients. It aims to evaluate how these programs impact physical health (like lung function), immune response and mental well-being.

How Is the Trial Designed?

Group I: +/- PEM Experimental Treatment 1 Intervention

Patients with and without Post Exertional Malaise (PEM) will receive 10 weeks of on site low to moderate intensity exercise rehabilitation.

Virtual vs On Site Pulmonary Rehabilitation is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Virtual Pulmonary Rehabilitation for:

• Chronic Obstructive Pulmonary Disease (COPD)
• Post-COVID Syndrome (PCS)
• Other Chronic Respiratory Conditions

Approved in Canada as Telerehabilitation for:

• COPD
• Chronic Lung Disease

Approved in European Union as Home-Based Pulmonary Rehabilitation for:

• COPD
• Chronic Respiratory Conditions

Who Is Running the Clinical Trial?

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Lead Sponsor

Trials

105

Recruited

46,600+

Published Research Related to This Trial

A hybrid tele-pulmonary rehabilitation (tele-PR) program, combining remote sessions with in-person assessments, significantly improved various health metrics in 31 post-COVID-19 patients over an eight-week period, including exercise capacity, muscle strength, and quality of life.

The program demonstrated safety and efficacy by effectively addressing persistent symptoms such as dyspnea and fatigue, indicating that tele-PR can be a valuable approach for rehabilitation in patients recovering from COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-pulmonary rehabilitation with face to face in COVID-19 pandemic: A hybrid modeling. Satar, S., Şahin, ME., Karamanlı, H., 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]

Tele-pulmonary rehabilitation has emerged as a feasible and effective alternative to traditional in-person pulmonary rehabilitation for patients with chronic obstructive pulmonary disease (COPD), especially during the COVID-19 pandemic.

A hybrid model combining both in-person and remote components may be the best approach for delivering pulmonary rehabilitation in the future, but further high-quality studies and collaboration are needed to optimize this model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation in a postcoronavirus disease 2019 world: feasibility, challenges, and solutions. Wen, J., Milne, S., Sin, DD.[2023]

Pulmonary Rehabilitation (PR) shows qualitative improvements in dyspnea, physical function, and quality of life for patients recovering from post-acute COVID-19, based on a systematic review of 11 studies with 677 participants.

Despite these qualitative benefits, a meta-analysis revealed no significant overall changes in outcomes when comparing PR to control groups, highlighting the need for standardized assessment methods in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary Rehabilitation in SARS-CoV-2: A Systematic Review and Meta-Analysis of Post-Acute Patients. Reinert, G., Müller, D., Wagner, P., et al.[2022]

In a case series of nine patients with post-acute COVID-19 symptoms, 24 sessions of supervised pulmonary telerehabilitation led to significant improvements in exercise capacity, as evidenced by enhanced performance on the 6-minute walk test and improvements in VO2 peak.

The telerehabilitation program also resulted in better pulmonary function for many participants, with seven patients showing increased forced vital capacity and six improving forced expiratory volume, highlighting the potential of this approach for managing PACS symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcome of supervised pulmonary telerehabilitation program among adult patients with post-acute COVID-19 symptoms (PACS): A case series. Dalisay, NJ., Ong-Dela Cruz, B., Punzal, P., et al.[2023]

Home-based telehealth pulmonary rehabilitation (HTPR) for chronic obstructive pulmonary disease (COPD) has been shown to be as effective as traditional outpatient rehabilitation programs and significantly better than usual care, based on a review of 38 studies involving 1993 participants.

The review highlighted the variability in HTPR program designs, with common components including exercise and education, but noted that neither HTPR nor outpatient programs significantly reduced sedentary time or increased step counts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and delivery of home-based telehealth pulmonary rehabilitation programs in COPD: A systematic review and meta-analysis. Michaelchuk, W., Oliveira, A., Marzolini, S., et al.[2022]

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]

Tele-rehabilitation for pulmonary rehabilitation (PR) is a feasible and effective alternative to traditional clinic-based PR, showing similar benefits for patients with chronic lung disease, based on a review of 26 studies.

The existing data suggests that remotely based PR does not diminish the effectiveness of conventional PR, making it a valuable option for patients facing barriers to attending in-person sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Will Remotely Based Pulmonary Rehabilitation Water Down Its Effectiveness? Rawal, H., Cornelison, SD., Flynn, SM., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11907626/

Effect of pulmonary rehabilitation for patients with long COVID ... PR improves physical capacity, lung function, and quality of life and alleviates dyspnea, fatigue, and anxiety in long COVID-19 patients. A 4- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07046442

Effect of Pulmonary Rehabilitation and Physical Activity on ... Rehabilitation programs have been shown to improve ambulation, hospital discharge rates, and overall recovery in COVID-19 patients, highlighting ...

3. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-024-02857-4

Effectiveness of pulmonary rehabilitation programmes and/or ... The primary objective of this study was to assess the effectiveness of pulmonary rehabilitation programs and/or respiratory muscle training on ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0954611122000476

The effectiveness of pulmonary rehabilitation for Post- ... All studies reported improvements in exercise capacity, pulmonary function, and/or quality of life for individuals with post-COVID symptoms who had been ...

5. mdpi.com mdpi.com/2077-0383/14/13/4533

Breathe Better After COVID: The Impact of a Two-Week ... A pulmonary rehabilitation program significantly improved pulmonary function, reduced systemic inflammation, and enhanced quality of life in individuals with ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828267

Brief Outpatient Rehabilitation Program for Post–COVID-19 ... This randomized clinical trial examines the effectiveness of a 2- to 6-week outpatient cognitive and behavioral rehabilitation program for individuals.

7. mdpi.com mdpi.com/1660-4601/21/2/242

Safety and Efficacy of Pulmonary Rehabilitation for Long ... Our results show that in-PR is safe and efficient at decreasing long-lasting symptoms experienced by long COVID patients at more than six months after initial ...

8. publications.ersnet.org publications.ersnet.org/content/erj/58/suppl65/pa3896

Late Breaking Abstract - Effects of pulmonary rehabilitation on ... Exercise tolerance and quality of life also improved (all p<.05). PR seems effective to relieve dyspnea and fatigue in patients with residual COVID-19 symptoms ...