Ireland
--:--IST
Recruiting Not applicable

Cycling Within an Interactive and Immersive Virtual Environment During Critical Illness: a Patient-centred Approach for Lower Limb Rehabilitation

NCT07894146 · tracked via the Priya Life Science Belgium tracker
Sponsor
Phase
Not applicable
Started
2026-06-29
Last updated
2026-10-26

Condition(s) studied

Critical Illness

Investigational drug(s) / intervention(s)

Basic-CycleTV-CycleVR-Cycle

Basic-Cycle: Cycling without visual support

TV-Cycle: Cycling while viewing a cycling route on an external television screen

VR-Cycle: Cycling within an immersive, interactive virtual reality environment

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Intrinsic Motivation — Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3
    Self-reported patient-reported outcome measured using the Intrinsic Motivation subscale of the Situational Motivation Scale (SIMS). It consists of four items rated on a 7-point Likert scale, ranging from 1 (does not correspond at all) to 7 (corresponds exactly). The subscale score is calculated as the mean of the four items, ranging from 1 to 7. Higher scores indicate greater intrinsic motivation and therefore a more favorable outcome.

Trial sites (1)

FacilityCityRegionStatus
University Hospitals Leuven Leuven Belgium Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07894146 on ClinicalTrials.gov ↗ ← All trials in Belgium