300 Participants Needed

Structured Pacing for Long COVID

BH
NI
Overseen ByNilda Itchon-Ramos
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.12345

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.12367

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.

Research Team

GM

Gary M Felker, MD

Principal Investigator

Duke Clinical Research Institute

BM

Barry Make, MD

Principal Investigator

National Jewish Health

LB

Lucinda Bateman, MD

Principal Investigator

Bateman Horne Center

JF

Janna Friedly, MD, MPH

Principal Investigator

University of Washington

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.

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
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
2Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment1 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 Treatment1 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

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+

Findings from Research

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

References

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]
The relevance of pacing strategies in managing symptoms of post-COVID-19 syndrome. [2023]
Characteristics and Treatment of Exercise Intolerance in Patients With Long COVID. [2023]
Importance of Cardiopulmonary Exercise Testing amongst Subjects Recovering from COVID-19. [2021]
Post-exertional symptoms distinguish Myalgic Encephalomyelitis/Chronic Fatigue Syndrome subjects from healthy controls. [2021]
Do not forget the lungs: preliminary feasibility study on I/E mode physiotherapy for people recovering from COVID-19. [2022]
A Case Study of Successful Application of the Principles of ME/CFS Care to an Individual with Long COVID. [2023]
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.
Back to top
Terms of Service·Privacy Policy·Cookies·Security