Cardiopulmonary Rehabilitation for Long COVID

Overseen By Barrie Harper

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Hypertension, Myocardial infarction, Arrhythmias, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore new methods to assist individuals with Long COVID who experience exercise intolerance and post-exertional malaise (PEM). Participants will either attend educational sessions or participate in a 12-week personalized cardiopulmonary rehabilitation program to enhance their exercise capacity and quality of life. This trial suits those with ongoing COVID-19 symptoms who struggle to exercise or perform daily activities without exhaustion. However, individuals with certain heart conditions or those who already exercise regularly may not qualify. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance support for Long COVID patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cardiopulmonary rehabilitation is safe for individuals, even after severe COVID-19. These personalized programs can enhance the quality of life and physical fitness in long-COVID patients. Most participants tolerate them well, typically without serious side effects.

However, one study found that certain exercises, such as interval training, might not be safe for long-COVID patients. Therefore, exercises must be selected and monitored carefully to ensure safety. Overall, when supervised and personalized, cardiopulmonary rehabilitation remains safe and effective for most individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the personalized cardiopulmonary rehabilitation for Long COVID because it offers a tailored approach compared to the standard of care, which typically involves general exercise advice and symptom management. Unlike conventional treatments, this method provides a customized rehabilitation plan designed to address individual exercise intolerance, potentially leading to more effective recovery. Additionally, the inclusion of a follow-up period ensures continued support and monitoring, which could enhance long-term health outcomes for participants. This personalized method stands out as it might significantly improve the quality of life for those experiencing persistent symptoms after COVID-19.

What evidence suggests that this trial's treatments could be effective for Long COVID?

This trial will compare personalized cardiopulmonary rehabilitation with an education program for individuals with long COVID. Research has shown that personalized heart and lung rehabilitation can significantly improve the health of patients recovering from severe COVID-19. One study found that most patients with post-COVID syndrome, including those who struggle with exercise and feel worse after activity, benefit from this type of rehabilitation. The treatment creates custom exercise plans to help patients gradually increase their ability to exercise and manage daily tasks. These plans, tailored to each person's needs, prove more effective than general exercise programs. Overall, evidence suggests that this approach can enhance the quality of life for those dealing with long COVID symptoms. ^{2 6 7 8 9}

Who Is on the Research Team?

Lucinda Bateman, MD

Principal Investigator

Bateman Horne Center

Janna Friedly, MD, MPH

Principal Investigator

University of Washington

Gary M Felker, MD

Principal Investigator

Duke Clinical Research Institute

Barry Make, MD

Principal Investigator

National Jewish Health

Are You a Good Fit for This Trial?

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 cannot walk.

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Cardiopulmonary Rehabilitation

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.

How Is the Trial Designed?

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+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0003999324007779

Long COVID (Post Acute Sequelae of SARS-CoV-2 ... Objective(s). To assess and report current effective treatments on clinical outcomes for adults with Long-COVID. Data Sources. We searched PubMed ...

2. archives-pmr.org archives-pmr.org/article/S0003-9993(24)00777-9/fulltext

Long COVID (Post Acute Sequelae of SARS-CoV-2 ... Abstract. Objective(s). To assess and report current effective treatments on clinical outcomes for adults with Long-COVID.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999324007779

Long COVID (Post Acute Sequelae of SARS-CoV-2 ... To assess and report current effective treatments on clinical outcomes for adults with Long-COVID. Data Sources. We searched PubMed (NLM) from January 1 2021 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11650911/

Post-Acute Sequelae of SARS-CoV-2 Infections Most patients with post-COVID syndrome do improve with conventional cardiopulmonary rehabilitation. However, patients with post-exertional ...

5. withpower.com withpower.com/trial/phase-post-acute-covid-19-syndrome-5-2024-a611d

Cardiopulmonary Rehabilitation for Long COVID Research shows that personalized cardiopulmonary rehabilitation can significantly improve heart and lung function in patients recovering from severe COVID-19.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10830387/

Personalized pulmonary rehabilitation program for patients ... This study revealed that pulmonary rehabilitation can improve QoL and physical fitness in long‐COVID patients.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06404047

NCT06404047 | RECOVER-ENERGIZE Platform Protocol This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11336035/

Optimizing cardiopulmonary rehabilitation duration for long ... This decision was based on previous research, that found interval training and graded exercises can be harmful for long COVID patients [76]. The association ...

9. trials.recovercovid.org trials.recovercovid.org/documents/RECOVER_ENERGIZE_Protocol_v.2.0.pdf

RECOVER-ENERGIZE: A Platform Protocol for Evaluation ... Individualized, supervised, cardiopulmonary rehabilitation is considered a safe and effective intervention for most cardiac and pulmonary ...