Structured Pacing for Long COVID

Overseen By Nilda Itchon-Ramos

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Inability to attend visits, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with Long COVID who struggle with exercise intolerance and post-exertional malaise (PEM), which is extreme fatigue after physical or mental effort. The study tests a method called "structured pacing," where participants learn to manage activities to avoid triggering symptoms. One group will receive standard care, while the other will participate in weekly pacing sessions with a specialized coach. This trial suits individuals who have experienced new or worsening PEM symptoms for at least 12 weeks following a COVID-19 infection. As an unphased study, this trial offers a unique opportunity to explore innovative strategies for managing Long COVID symptoms.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that this protocol is safe for addressing exercise intolerance and post-exertional malaise in PASC patients?

Research has shown that structured pacing can safely help manage Long COVID symptoms, particularly post-exertional malaise (PEM), where symptoms worsen after physical or mental activity. Studies have found that following a structured pacing plan can significantly reduce these flare-ups and improve overall health for people with post-COVID syndrome.

Participants in these studies handled the pacing well, with no reports of serious side effects, indicating that structured pacing is generally safe and well-tolerated. This method involves working with a pacing coach to balance activity and rest, preventing overexertion and managing symptoms effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about structured pacing for Long COVID because it offers a tailored approach to managing post-exertional malaise (PEM), a common symptom in Long COVID patients. Unlike standard care options, which may include general advice or symptom management, structured pacing involves personalized coaching to help individuals understand and adapt their activities based on their specific PEM triggers and symptoms. This method empowers patients to manage their energy levels more effectively, potentially improving daily functioning and quality of life. By focusing on individualized pacing strategies, this approach could provide a more sustainable way to manage Long COVID symptoms compared to traditional methods.

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

Research has shown that a structured pacing plan can greatly help people with long COVID. Earlier studies found that this approach reduced flare-ups of symptoms after physical or mental activity. It also improved overall health and exercise capacity. Participants learned to manage their energy better and avoid overexertion. In this trial, participants in the Structured Pacing arm will complete weekly pacing sessions to assess its effectiveness in easing long COVID symptoms. ^{1 2 3 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

This trial is for individuals experiencing Long COVID or Post-COVID Syndrome, specifically those with exercise intolerance and post-exertional malaise. Participants should be part of the RECOVER-ENERGIZE study (see NCT number provided) and meet its inclusion criteria.

Inclusion Criteria

I meet the inclusion criteria listed in the RECOVER-ENERGIZE study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly pacing sessions for 12 weeks, including PEM symptom and trigger assessment, task, function and activity analysis, and adaptations and modifications.

12 weeks

Weekly sessions with a pacing coach

Follow-up

Participants are monitored for changes in PEM symptoms, physical activity, and quality of life after treatment

6 months

Assessments at month 6

What Are the Treatments Tested in This Trial?

Interventions

• Structured Pacing

Trial Overview The trial is testing 'Structured Pacing' against 'Usual Care' to see if it can improve exercise capacity, daily activity tolerance, and quality of life in patients with Post-Acute Sequelae of SARS-CoV-2 Infection (PASC).

How Is the Trial Designed?

Group I: Usual Care Experimental Treatment 1 Intervention

Participants in this group will receive basic education about PEM with a weekly call by site study staff for support and communication.

Group II: Structured Pacing (PEM) Experimental Treatment 1 Intervention

Participants in this group will complete weekly pacing sessions for 12 weeks. Pacing sessions will last about 30 minutes, as tolerated. Each participant will meet with a provider 'pacing coach' who has received study-specific education about PEM and how to create and manage pacing strategies for participants. Sessions include PEM symptom and trigger assessment; task, function and activity analysis; adaptations and modifications.

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

A 19-year-old male with long COVID developed symptoms consistent with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and was treated using established ME/CFS management strategies, leading to significant symptom improvement over 30 months.

The case suggests that treatment approaches for ME/CFS, including physical therapy and targeted medications, may be beneficial for some patients suffering from long COVID, particularly those with overlapping symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case Study of Successful Application of the Principles of ME/CFS Care to an Individual with Long COVID. Petracek, LS., Broussard, CA., Swope, RL., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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]

In a study of 86 patients with post-COVID-19 syndrome (PCS) followed for a median of 10 months, pacing strategies led to a recovery rate of 33.7% and an improvement rate of 23.3%.

Higher adherence to pacing strategies was significantly associated with better recovery outcomes, with patients showing high engagement in pacing achieving recovery rates of 60% compared to only 5.5% in those with low adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relevance of pacing strategies in managing symptoms of post-COVID-19 syndrome. Ghali, A., Lacombe, V., Ravaiau, C., et al.[2023]

Long COVID affects 25-30% of individuals who have had SARS-CoV-2, leading to symptoms like fatigue and impaired functional capacity, highlighting the need for effective treatment strategies.

Tailored exercise prescriptions can help alleviate symptoms of Long COVID by addressing deconditioning caused by inactivity, suggesting that exercise may be a beneficial management approach for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and Treatment of Exercise Intolerance in Patients With Long COVID. Edward, JA., Peruri, A., Rudofker, E., et al.[2023]

Patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) reported an average of 14 symptoms after exercise testing, significantly more than the 4 symptoms reported by healthy controls, highlighting the severity of post-exertional malaise (PEM) in ME/CFS.

The study identified that ME/CFS patients experienced prolonged symptoms, particularly cognitive dysfunction and fatigue, following standardized exercise, which may help improve understanding and treatment of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-exertional symptoms distinguish Myalgic Encephalomyelitis/Chronic Fatigue Syndrome subjects from healthy controls. Mateo, LJ., Chu, L., Stevens, S., et al.[2021]

A study involving 20 patients with post-COVID syndrome demonstrated that guided in/expiratory (I/E) chest physiotherapy significantly improved lung function, with forced vital capacity (FVC) increasing by 10.9% and forced expiratory volume (FEV1) by 8%.

Patients also reported enhanced Quality of Life and exercise capacity, with a 14.2% improvement in the 6-minute walk test, indicating that this method effectively alleviates respiratory symptoms and enhances overall health post-COVID.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do not forget the lungs: preliminary feasibility study on I/E mode physiotherapy for people recovering from COVID-19. Pestelli, MT., D'Abrosca, F., Tognetti, P., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9878088/

Effect of using a structured pacing protocol on post‐ ... A structured pacing protocol significantly reduces PESE episodes and improves overall health in PCS.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06404073

Study Details | NCT06404073 | RECOVER-ENERGIZE ... Participant identifies new PEM following a SARS-CoV-2 infection that has persisted for at least 12 weeks and is still present at the time of consent; Score of 2 ...

3. reaganudall.org reaganudall.org/clinical-trial/recover-energize-platform-protocolappendix-b-structured-pacing-pem

RECOVER-ENERGIZE Platform Protocol_Appendix B ... 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.

4. withpower.com withpower.com/trial/phase-post-acute-covid-19-pacs-or-long-covid-syndrome-5-2024-1ed29

Structured Pacing for Long COVID · Info for Participants A 6-week structured pacing protocol significantly reduced the average number of post-exertional symptom exacerbation (PESE) episodes in individuals with long- ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06404047

NCT06404047 | RECOVER-ENERGIZE Platform Protocol Appendix B is a randomized controlled trial designed to evaluate the effect of a 12-week Structured Pacing intervention on reducing the symptoms of post- ...

6. researchgate.net researchgate.net/publication/365980230_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

(PDF) Effect of using a structured pacing protocol on post‐ ... Objectives: This prospective study investigated the effect of a 6-week structured World Health Organisation (WHO) Borg CR-10 5-phase pacing protocol on PESE ...

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

RECOVER-ENERGIZE: A Platform Protocol for Evaluation ... This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve.