| NCT ID | NCT06373341 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Frisius Medisch Centrum |
| Condition | Post-Intensive Care Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 108 participants in total. It began in 2024-01-15 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients admitted to the ICU due to critical illness often experience physical, mental, cognitive, or social issues. Research indicates that inadequate physical recovery is associated with lower handgrip strength, and hand function in ICU patients is lower compared to healthy individuals. To address this, a Virtual Reality (VR) exergame was developed to aid rehabilitation. This study aims to investigate the effect of a 4-week VR-exergame intervention on handgrip strength, hand and arm functionality, balance, mobility, and support needs in ICU patients staying for 48 hours or longer. It is a multicenter mixed-methods randomized controlled trial involving adult ICU patients. The intervention involves a 4-week VR-exergame program. Main study parameters include handgrip strength, hand and arm functionality, range of motion, balance, mobility, and support needs. The burden and risks associated with participation are minimal, as VR-based exercises are deemed safe and voluntary. Overall, the study aims to assess the effect of incorporating VR-based rehabilitation into standard care for ICU patients.
Eligibility Criteria
Inclusion Criteria: * Length of stay ICU ≥48 hours * Lives in catchment area of one of the Frisian hospitals * Understands the Dutch language * Intact motor skills of at least one upper extremity Exclusion Criteria: * Active delirium (CAM-ICU ≥1) * Severe cognitive dysfunction * Internal cardiac defibrillator
Contact & Investigator
Lise Beumeler, PhD
PRINCIPAL INVESTIGATOR
Frisius Medisch Centrum
Frequently Asked Questions
Who can join the NCT06373341 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post-Intensive Care Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06373341 currently recruiting?
Yes, NCT06373341 is actively recruiting participants. Contact the research team at lise.beumeler@mcl.nl for enrollment information.
Where is the NCT06373341 trial being conducted?
This trial is being conducted at Leeuwarden, Netherlands.
Who is sponsoring the NCT06373341 clinical trial?
NCT06373341 is sponsored by Frisius Medisch Centrum. The principal investigator is Lise Beumeler, PhD at Frisius Medisch Centrum. The trial plans to enroll 108 participants.