Cardiopulmonary Rehabilitation for Long COVID

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Duke University

Disqualifiers: Hypertension, Myocardial infarction, Arrhythmias, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). The focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC.

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's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Personalized Cardiopulmonary Rehabilitation, Personalized Cardiopulmonary Rehabilitation, Structured Pacing for Long COVID?

Research shows that personalized cardiopulmonary rehabilitation can significantly improve heart and lung function in patients recovering from severe COVID-19. Studies found improvements in physical performance and quality of life, with benefits seen in both low- and high-intensity rehabilitation programs. ^{1 2 3 4 5}

Is cardiopulmonary rehabilitation safe for humans?

Cardiopulmonary rehabilitation, including personalized and structured programs, has been shown to be safe for humans, even after severe COVID-19. Studies indicate that it can improve heart and lung function without significant safety concerns. ^{1 2 3 6 7}

How does the treatment Personalized Cardiopulmonary Rehabilitation differ from other treatments for Long COVID?

Personalized Cardiopulmonary Rehabilitation is unique because it tailors the intensity and type of exercises to each patient's recovery needs, focusing on improving heart and lung function through structured pacing and individualized protocols. This approach contrasts with standard treatments by emphasizing personalized exercise regimens to enhance physical capacity and reduce symptoms like fatigue and breathlessness. ^{2 3 4 5 8}

Research Team

Gary M Felker, MD

Principal Investigator

Duke Clinical Research Institute

Barry Make, MD

Principal Investigator

National Jewish Health

Lucinda Bateman, MD

Principal Investigator

Bateman Horne Center

Janna Friedly, MD, MPH

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for individuals experiencing lingering symptoms after COVID-19, known as Long COVID or Post-COVID Syndrome. Participants should have issues with exercise tolerance and post-exertional malaise. Specific eligibility details are listed in a separate document (NCT########).

Inclusion Criteria

See NCT06404047 for RECOVER-ENERGIZE: Platform Protocol level inclusion and exclusion criteria which applies to this appendix

Engaged in purposeful moderate or greater intensity exercise with the intent to improve one's health 2 or more times per week over the 30 days prior to informed consent

Exclusion Criteria

I often feel very tired and this has been confirmed by a specific questionnaire.

A selection of ≥ 8 on question 1 or ≥ 9 on question 3 of the OH Activity Scale from the mOHQ

I cannot walk.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week personalized cardiopulmonary rehabilitation intervention

12 weeks

Weekly phone/virtual follow-ups

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Personalized Cardiopulmonary Rehabilitation (Behavioral Intervention)

Trial Overview The study is testing educational programs and personalized cardiopulmonary rehabilitation to see if they can help improve the ability to exercise, perform daily activities, and enhance overall quality of life for those with Post-Acute Sequelae of SARS-CoV-2 Infection.

Participant Groups

Group I: Cardiopulmonary Rehabilitation (Exercise Intolerance) Experimental Treatment 1 Intervention

Participants assigned to Cardiopulmonary Rehabilitation will undergo a 12-week personalized cardiopulmonary rehabilitation intervention with a follow-up period of 3 months (total study duration of 6 months).

Group II: Education Active Control 1 Intervention

Participants in this group will receive two general education sessions at the start of the intervention with weekly phone/virtual follow-ups from site study staff.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

Findings from Research

A study of 28 patients recovering from severe COVID-19 showed that comprehensive cardiopulmonary rehabilitation is safe and feasible, leading to significant improvements in physical performance and subjective health status.

Improvements in the 6-minute walking test and overall well-being were observed regardless of whether patients had been on a ventilator, indicating that rehabilitation can benefit all patients recovering from severe COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Efficacy of Cardiopulmonary Rehabilitation After COVID-19. Hermann, M., Pekacka-Egli, AM., Witassek, F., et al.[2023]

An 8-week personalized pulmonary rehabilitation program for post-COVID-19 patients significantly improved lung function, as shown by an increase in forced vital capacity from 2.47 to 3.06 liters, and enhanced exercise capacity with a six-minute walk test result rising from 363.5 to 480.9 meters.

The program also led to a notable reduction in fatigue perception, decreasing from 24.92 to 19.10 points, along with improvements in heart rate and dyspnoea, indicating a comprehensive benefit for patients recovering from severe COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the speed achieved on the 6MWT for programming aerobic training in patients recovering from severe COVID-19: an observational study. Del Valle, MF., Valenzuela, J., Marzuca-Nassr, GN., et al.[2023]

A study of 84 patients recovering from severe COVID-19 showed that both low-intensity and high-intensity rehabilitation significantly improved various cardiopulmonary health markers, including lung function and heart efficiency, over a 3-month period.

Personalized rehabilitation strategies were effective in enhancing recovery, emphasizing the need for tailored approaches based on individual patient needs to optimize long-term cardiopulmonary health post-COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-Severe-COVID-19 Cardiopulmonary Rehabilitation: A Comprehensive Study on Patient Features and Recovery Dynamics in Correlation with Workout Intensity. Dumitrescu, A., Doros, G., Lazureanu, VE., et al.[2023]

A study of 176 COVID-19 patients showed that physical performance, measured by the 6-minute walk test, was suboptimal both before discharge and one month later, indicating incomplete recovery after hospitalization.

Younger patients with more extensive lung damage and higher inflammation markers (like ESR) were identified as having a poor recovery trajectory, suggesting that specific predictors can help target rehabilitation efforts more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneous physical functional recovery after hospitalization for COVID-19: insights from a 1 month follow-up and a model to predict poor trajectory. Honchar, O., Ashcheulova, T.[2023]

A cardiopulmonary rehabilitation program for post-COVID-19 patients showed significant improvements in functional capacity, with participants increasing their 6-Minute Walk Test distance by 16% to 94% after three months of rehabilitation.

The program also enhanced peripheral muscle strength by 20% to six times the baseline values and reduced the double product at rest by 8% to 42%, indicating a positive impact on overall health despite varying severity levels of the patients' conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiopulmonary rehabilitation in post-COVID-19 patients: case series. Tozato, C., Ferreira, BFC., Dalavina, JP., et al.[2021]

In a study of 28 subjects recovered from hospitalized COVID-19, 29% exhibited exercise ventilatory inefficiency (EVin), indicating significant cardiopulmonary alterations post-recovery.

A notable finding was the inverse correlation between the VE/VCO2 slope and heart rate recovery, suggesting that EVin may serve as a new indicator of cardiopulmonary issues in post-COVID patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of Cardiopulmonary Exercise Testing amongst Subjects Recovering from COVID-19. Dorelli, G., Braggio, M., Gabbiani, D., et al.[2021]

A study involving 24 patients in cardiopulmonary rehabilitation found that exercising while wearing procedural masks still resulted in significant increases in airborne particles, particularly in larger class sizes (four or more participants).

The increase in particle generation peaked around 35 to 40 minutes into the rehabilitation classes, raising concerns about the potential risk of infectious respiratory particles being produced during these sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Particulate Generation During Cardiopulmonary Rehabilitation Classes With Patients Wearing Procedural Masks. Helgeson, SA., Taylor, BJ., Lim, KG., et al.[2021]

Cardio-pulmonary rehabilitation significantly improved physical capacity in 25 discharged COVID-19 patients, with an 18% increase in maximal aerobic capacity (VO2 max) and a 26% increase in maximal workload after 23 rehabilitation sessions.

The program also reduced exercise hyperventilation by 10%, indicating that rehabilitation can enhance respiratory efficiency and overall physical performance in patients recovering from moderate to severe COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of Cardio-Pulmonary Rehabilitation in Moderate to Severe Forms of COVID-19 Infection. Douin, C., Forton, K., Lamotte, M., et al.[2022]

References

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

Feasibility and Efficacy of Cardiopulmonary Rehabilitation After COVID-19. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Use of the speed achieved on the 6MWT for programming aerobic training in patients recovering from severe COVID-19: an observational study. [2023]

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

Post-Severe-COVID-19 Cardiopulmonary Rehabilitation: A Comprehensive Study on Patient Features and Recovery Dynamics in Correlation with Workout Intensity. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Spontaneous physical functional recovery after hospitalization for COVID-19: insights from a 1 month follow-up and a model to predict poor trajectory. [2023]

5. Brazil pubmed.ncbi.nlm.nih.gov

Cardiopulmonary rehabilitation in post-COVID-19 patients: case series. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Importance of Cardiopulmonary Exercise Testing amongst Subjects Recovering from COVID-19. [2021]

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

Characterizing Particulate Generation During Cardiopulmonary Rehabilitation Classes With Patients Wearing Procedural Masks. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Benefits of Cardio-Pulmonary Rehabilitation in Moderate to Severe Forms of COVID-19 Infection. [2022]