Structured Pacing for Long COVID

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Duke University

Disqualifiers: Inability to attend visits, 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.

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 data supports the effectiveness of the treatment Structured Pacing for Long COVID?

Research shows that a structured pacing protocol significantly reduced episodes of post-exertional symptom exacerbation in people with long COVID, improving their quality of life. This approach is similar to pacing strategies used effectively in managing symptoms of chronic fatigue syndrome, which shares features with long COVID. ^{1 2 3 4 5}

How is the treatment Structured Pacing for Long COVID different from other treatments for this condition?

Structured Pacing for Long COVID is unique because it uses a specific 5-phase pacing protocol to manage post-exertional symptom exacerbation (PESE), which is a common issue in long COVID. This approach is adapted from strategies used in managing myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and involves regular clinician support to tailor the pacing to individual needs, unlike other treatments that may not focus on structured activity management. ^{1 2 3 6 7}

Research Team

Janna Friedly, MD, MPH

Principal Investigator

University of Washington

Lucinda Bateman, MD

Principal Investigator

Bateman Horne Center

Gary M Felker, MD

Principal Investigator

Duke Clinical Research Institute

Barry Make, MD

Principal Investigator

National Jewish Health

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Structured Pacing (Behavioral Intervention)

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).

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

All sites listed under NCT06404047 Durham, NC

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2495

Patients Recruited

5,912,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3987

Patients Recruited

47,860,000+

References

1. United States 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. [2023]

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

The relevance of pacing strategies in managing symptoms of post-COVID-19 syndrome. [2023]

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

Characteristics and Treatment of Exercise Intolerance in Patients With Long COVID. [2023]

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

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

5. Netherlands pubmed.ncbi.nlm.nih.gov

Post-exertional symptoms distinguish Myalgic Encephalomyelitis/Chronic Fatigue Syndrome subjects from healthy controls. [2021]

6. Italy pubmed.ncbi.nlm.nih.gov

Do not forget the lungs: preliminary feasibility study on I/E mode physiotherapy for people recovering from COVID-19. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Case Study of Successful Application of the Principles of ME/CFS Care to an Individual with Long COVID. [2023]