Rehabilitation and Pacing for Long COVID

No longer recruiting at 45 trial locations
NI
BH
PA
Overseen ByPinky Agarwal, MD, FAAN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best methods to help people with Long COVID improve their exercise capacity and manage daily activities. It tests two main treatments: personalized cardiopulmonary rehabilitation (a tailored exercise program) and structured pacing (a method to manage activity levels). These treatments focus on reducing symptoms such as extreme tiredness and shortness of breath following even light activity. Individuals who have had COVID-19 and continue to experience fatigue, shortness of breath, or significant tiredness after simple tasks for at least 12 weeks may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to enhance understanding of effective treatments for Long COVID symptoms.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently using a formal program similar to the study interventions, you may need a washout period (time without taking certain medications) as per the trial's appendices.

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

Research has shown that personalized heart and lung rehabilitation is generally well-received by patients recovering from severe COVID-19, significantly improving heart and lung function. This treatment includes customized exercise plans with safe levels of strength and endurance exercises.

Structured pacing helps manage energy levels and reduce tiredness after activity, known as post-exertional malaise (PEM). While specific safety data for structured pacing in long COVID patients remains limited, this gentle approach aims to manage symptoms by gradually increasing activity levels.

Both treatments aim to improve exercise capacity and enhance quality of life. Since these treatments do not involve drugs, they usually present fewer risks compared to medication. However, specific safety information for these treatments will become clearer as more studies are completed.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for Long COVID because they offer personalized, non-pharmacological approaches that specifically target different aspects of the condition. The Structured Pacing protocol is designed to help manage post-exertional malaise (PEM) by teaching patients how to balance their activity levels, which is a fresh approach compared to traditional medication or general advice. On the other hand, the Personalized Cardiopulmonary Rehabilitation focuses on improving exercise tolerance through tailored physical therapy, a more individualized approach than standard exercise programs. These treatments aim to provide targeted relief for Long COVID symptoms, potentially leading to more effective management strategies.

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

This trial will compare two approaches for managing long-term COVID-19 symptoms. Research has shown that personalized cardiopulmonary rehabilitation, which participants in this trial may receive, can significantly improve the health of people recovering from severe COVID-19 by increasing exercise ability, reducing tiredness, and enhancing quality of life. Another treatment option in this trial is a structured pacing plan, which has proven effective in reducing the frequency and severity of post-exertional malaise (PEM), a condition where individuals feel very tired after activity. These findings suggest that both approaches may help those with long-term COVID-19 symptoms manage their symptoms better and improve their daily lives.26789

Who Is on the Research Team?

JF

Janna Friedly, MD, MPH

Principal Investigator

University of Washington

LB

Lucinda Bateman, MD

Principal Investigator

Bateman Horne Center

GM

Gary M Felker, MD

Principal Investigator

Duke Clinical Research Institute

BM

Barry Make, MD

Principal Investigator

National Jewish Health

Are You a Good Fit for This Trial?

Adults over 18 who had confirmed or suspected COVID-19 before May 1, 2021, experiencing lasting symptoms like fatigue and shortness of breath for at least 12 weeks. Participants must be able to give consent and complete study tasks. Only a small portion can have unconfirmed cases.

Inclusion Criteria

I have had physical limitations for over 12 weeks due to long COVID.
I am willing to sign consent, answer questions, and follow the study's procedures.
I might have had COVID-19 before May 1, 2021.
See 2 more

Exclusion Criteria

Participation in another interventional clinical trial
Any condition that would make the participant unsuitable for the study
I have been diagnosed with Chronic Fatigue Syndrome not caused by COVID-19.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a 12-week Structured Pacing intervention or a 12-week personalized cardiopulmonary rehabilitation intervention

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Personalized Cardiopulmonary Rehabilitation
  • Structured Pacing
Trial Overview The trial is testing personalized cardiopulmonary rehabilitation, structured pacing, education against usual care in improving exercise capacity and quality of life in long COVID patients. It's multi-center and randomized.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Experimental: Appendix B - Structured Pacing (PEM)Experimental Treatment2 Interventions
Group II: Experimental: Appendix A - Cardiopulmonary Rehabilitation (Exercise Intolerance)Experimental Treatment2 Interventions

Find a Clinic Near You

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

An individualized physical rehabilitation program (PRP) was well tolerated by inotrope-dependent patients with end-stage chronic heart failure (CHF), with over 80% attendance and no life-threatening adverse events reported during the 6-month study involving 120 participants.
The study demonstrated that continued inotropic support (dobutamine or dopamine) does not contraindicate participation in PR, as patients showed comparable exercise intensity and lactate levels to those without inotropic support, indicating safety in this population.
Tolerability of an Individualized Physical Rehabilitation Program in Patients Dependent on Inotropic Support With End-Stage Chronic Heart Failure.Bortsova, MA., Demchenko, EA., Fedotov, PA., et al.[2023]
A 6-week structured pacing protocol significantly reduced the average number of post-exertional symptom exacerbation (PESE) episodes in individuals with long-standing post-COVID syndrome, from 3.4 episodes in Week 1 to 1.1 in Week 6.
Participants also experienced improved overall health, as indicated by an increase in EQ-5D 5L scores from 51.4 to 60.6 points, demonstrating both the efficacy of the pacing protocol and its positive impact on quality of life.
Effect of using a structured pacing protocol on post-exertional symptom exacerbation and health status in a longitudinal cohort with the post-COVID-19 syndrome.Parker, M., Sawant, HB., Flannery, T., et al.[2023]
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.
Benefits of Cardio-Pulmonary Rehabilitation in Moderate to Severe Forms of COVID-19 Infection.Douin, C., Forton, K., Lamotte, M., et al.[2022]

Citations

A Personalised Pacing and Active Rest Rehabilitation ...Conclusions: A structured pacing protocol effectively reduced PESE episode frequency, duration, and severity but did not produce clinically significant changes ...
Optimizing cardiopulmonary rehabilitation duration for long ...Our follow-up study proved that a 2-week long, patient-centered pulmonary rehabilitation program has a positive long-term effect on people with symptomatic ...
NCT06404047 | RECOVER-ENERGIZE Platform ProtocolAppendix A is a randomized controlled trial designed to evaluate the effect of a 12-week personalized cardiopulmonary rehabilitation intervention on exercise ...
Cardiopulmonary Rehabilitation for Long COVIDResearch shows that personalized cardiopulmonary rehabilitation can significantly improve heart and lung function in patients recovering from severe COVID-19.
Cardiopulmonary rehabilitation programme improves physical ...Outpatient Pulmonary Rehabilitation in Patients with Long COVID Improves Exercise Capacity, Functional Status, Dyspnea, Fatigue, and Quality of Life ...
6.trials.recovercovid.orgtrials.recovercovid.org/ENERGIZE
recover-energizeWithout the control groups to use as points of comparison, researchers would not be able to learn how the active study programs affect Long COVID symptoms.
Rehabilitation and Pacing for Long COVIDResearch shows that personalized cardiopulmonary rehabilitation can significantly improve heart and lung function in patients recovering from severe COVID-19, ...
Personalized Exercise Prescription in Long COVIDPersonalized exercise prescription includes resistance training at a submaximal threshold (4–6 exercises, 3 days/week); whole-body endurance exercise titrated ...
A Personalised Pacing and Active Rest Rehabilitation ...A National Evaluation of Outcomes in Long COVID Services Using Digital PROM Data from the ELAROS Platform. LOCO-MOTION and ELAROS, Published by NHS England ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security