40 Participants Needed

Pulmonary Rehabilitation for Post-COVID Syndrome

(LHCRehab Trial)

LD
WW
Overseen ByWilliam W Stringer, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the idea that Pulmonary Rehabilitation for Post-COVID Syndrome is an effective treatment?

The available research shows that Pulmonary Rehabilitation, whether done remotely or in-person, is effective for people recovering from COVID-19. Studies have found that remote methods like telerehabilitation are just as beneficial as traditional in-person programs. These methods help improve symptoms and overall health, making them a good option for those who can't attend in-person sessions. This is especially important during the COVID-19 pandemic when many people have limited access to traditional rehabilitation centers.12345

What safety data exists for pulmonary rehabilitation for post-COVID syndrome?

The safety of pulmonary rehabilitation, including virtual and home-based methods, has been evaluated in various studies. These studies indicate that remotely based pulmonary rehabilitation, such as telerehabilitation and home-based programs, is feasible and effective for patients with lung diseases, including those recovering from COVID-19. Although there is variability in methods across studies, the existing data suggests that these alternative delivery methods do not compromise the effectiveness of traditional pulmonary rehabilitation. However, more high-quality studies are needed to further assess the safety, efficacy, and cost-effectiveness of these programs.12346

Is Virtual vs On Site Pulmonary Rehabilitation a promising treatment for Post-COVID Syndrome?

Yes, Virtual Pulmonary Rehabilitation is promising because it helps improve exercise capacity, lung function, and quality of life for people recovering from COVID-19. It allows patients to receive care at home, reducing the risk of virus exposure and overcoming barriers like social isolation.13578

What is the purpose of this trial?

The purpose of the study is to assess the physiologic, immunologic, and mental health effects of a rehabilitation program on patients with Long Haul COVID (LHC).

Eligibility Criteria

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.
See 4 more

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.
See 6 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: No PEMExperimental Treatment1 Intervention
Patients who do not experience Post Exertional Malaise (PEM) will receive 10 weeks of traditional pulmonary rehabilitation.
Group II: + PEMActive Control1 Intervention
Patients who experience Post Exertional Malaise (PEM) will receive 10 weeks of virtual 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Lead Sponsor

Trials
105
Recruited
46,600+

Findings from Research

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

Pulmonary rehabilitation in a postcoronavirus disease 2019 world: feasibility, challenges, and solutions. [2023]
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]
Pulmonary Rehabilitation in a Post-COVID-19 World: Telerehabilitation as a New Standard in Patients with COPD. [2021]
Will Remotely Based Pulmonary Rehabilitation Water Down Its Effectiveness? [2021]
Tele-pulmonary rehabilitation with face to face in COVID-19 pandemic: A hybrid modeling. [2023]
Design and delivery of home-based telehealth pulmonary rehabilitation programs in COPD: A systematic review and meta-analysis. [2022]
Pulmonary Rehabilitation in SARS-CoV-2: A Systematic Review and Meta-Analysis of Post-Acute Patients. [2022]
Clinical outcome of supervised pulmonary telerehabilitation program among adult patients with post-acute COVID-19 symptoms (PACS): A case series. [2023]
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