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NCT07894146
Cycling Within an Interactive and Immersive Virtual Environment During Critical Illness: a Patient-centred Approach for Lower Limb Rehabilitation
Conditions: Critical Illness
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: KU Leuven
Location: University Hospitals Leuven Leuven
Summary
This study aims to investigate whether combining cycling exercise with an immersive and interactive virtual reality (VR) environment improves motivation compared with cycling without visual support or cycling while watching a route on a television screen in critically ill patients admitted to the intensive care unit (ICU).
This randomized, within-subject crossover study will include 20 adult ICU patients who have been admitted for at least 7 days, have received mechanical ventilation for at least 48 hours, and are able to perform active cycling exercise.
Each participant will complete three 10-minute cycling sessions under different conditions: (1) cycling without visual support (Basic-Cycle), (2) cycling while watching a cycling route on a television screen (TV-Cycle), and (3) cycling within an immersive, interactive VR environment (VR-Cycle). The three conditions will be performed in random order over three consecutive days, with the cycling resistance kept constant across conditions for each participant.
The primary outcome is intrinsic motivation, assessed using the Situational Motivation Scale (SIMS). Secondary outcomes include other dimensions of motivation, perceived dyspnea, lower limb fatigue, pain, cycling distance, and safety measures, including vital signs and adverse events.
This study will provide insight into the potential of VR-assisted cycling to improve patient motivation and engagement during early rehabilitation in the ICU.
Eligibility Criteria
Inclusion Criteria:
* Admission to ICU ≥ 7 days
* ≥ 48h mechanical ventilation
* Expected additional ICU stay ≥ 7 more days
* Adult (≥18y)
* Awake and adequate
* Alert and calm (RASS -1 to +1)
* No medical contraindication for (bed-/chair-)cycling
* Able to perform 10 minutes of active cycling
Exclusion Criteria:
* Significant visual impairments
* Cognitive impairment (MMSE \< 20/30)
* Psychotic disorder
* Pregnancy
* Not able to understand Dutch, French or English
* Not able to provide informed consent
Source: ClinicalTrials.gov (NCT07894146). StuddyBuddy aggregates publicly available trial information.