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PEM-PACING

Towards tailored diagnostic testing to safely exercise in post-COVID patients - PEM-PACING

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON58079
Enrollment
180
Registered
2025-05-13
Start date
2026-03-18
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-COVID post-COVID

Interventions

This study examines a behavioral pacing intervention designed to prevent relapse into PEM by teaching participants to manage their activity levels below the PEM threshold. The 4-month intervention is

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Diagnosis of post-COVID: Confirmed COVID-19 and ongoing symptoms for at least three months, and no longer than two years • Laboratory testing performed after onset of COVID-19 confirming absence of anemia, diabetes, thyroid disorders, active inflammatory disease and/or hypovitaminosis for vitamins B12 and D3 as an alternative explanation for symptoms associated with post-COVID complaints. Individuals who have not had this test can still participate once they have completed the test with their general practitioner or medical specialist. • PEM: characterized by a worsening of symptoms following physical or mental exertion, confirmed by the DSQ-PEM questionnaire. A frequency of at least 2 and a severity of at least 2 on any one of the 5 questions on the DSQ-PEM subscale indicate that PEM is present. • Age range: 18-70 years  • Stable medical condition: no significant changes in medication or treatment for at least four weeks prior to enrolment

Exclusion criteria

Exclusion criteria: • No access to required technology, i.e., a smartphone and mobile internet • Orthopaedic, vascular, pulmonary, neuromuscular or other diseases prohibiting the ability to perform cycling exercise (group with mild disabilities) or to stand (group with severe disabilities) • Previous or current use of HRV or HR data to adjust personal activities under supervision of a sports physician • Participation in another intervention study

Design outcomes

Primary

MeasureTime frame
Change in self-reported PEM scores after 4 months of HR- and HRV-based pacing, measured by the FUNCAP-27 and DSQ-PEM questionnaires.

Secondary

MeasureTime frame
HRV (rMSSD)NIRS parametersParameters from CPETDysfunctional breathingPhysical activityFatigueQuality of lifeParticipationKinesiophobiaWork productivity

Countries

Netherlands

Contacts

Public ContactF Hartgens

Universitair Medisch Centrum Utrecht

l.m.g.hartgens@umcutrecht.nl088 75 588 31

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 3, 2026