An interventional study of Basic-Cycle and TV-Cycle in Critical Illness, sponsored by KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by KU Leuven · Not applicable, Interventional, and Treatment
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.
1,924 studies on the registry are indexed under Critical Illness; 465 are open to participants now.
This study's planned enrollment of 20 is below the median of 90 across 1,003 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →KU Leuven is the lead sponsor of 372 studies on the registry; 64 are open to participants now.
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Exclusion Criteria:
Behavioral: Basic-Cycle · Behavioral: TV-Cycle · Behavioral: VR-Cycle
Behavioral: Basic-Cycle · Behavioral: TV-Cycle · Behavioral: VR-Cycle
Behavioral: Basic-Cycle · Behavioral: TV-Cycle · Behavioral: VR-Cycle
Behavioral: Basic-Cycle · Behavioral: TV-Cycle · Behavioral: VR-Cycle
Behavioral: Basic-Cycle · Behavioral: TV-Cycle · Behavioral: VR-Cycle
Behavioral: Basic-Cycle · Behavioral: TV-Cycle · Behavioral: VR-Cycle
Cycling without visual support
Cycling while viewing a cycling route on an external television screen
Cycling within an immersive, interactive virtual reality environment
Intrinsic Motivation
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.
Time frame: Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3
Dyspnea
Dyspnea sensation is assessed using the Modified Borg Dyspnea Scale (Borg CR10 Scale). This patient-reported scale measures the perceived intensity of breathlessness during cycling. Scores range from 0 (no breathlessness at all) to 10 (maximal breathlessness). Higher scores indicate greater perceived dyspnea and therefore a worse outcome.
Time frame: Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3
Lower limb fatigue
Lower limb fatigue is assessed using the Modified Borg Dyspnea Scale (Borg CR10 Scale). This patient-reported scale measures the perceived intensity of leg fatigue during cycling. Scores range from 0 (no fatigue at all) to 10 (maximal fatigue). Higher scores indicate greater perceived lower limb fatigue and therefore a worse outcome.
Time frame: Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3
Pain
Pain perception is assessed using the Visual Analog Scale (VAS). This patient-reported scale measures the perceived intensity of pain during cycling. Scores range from 0 (no pain at all) to 10 (worst imaginable pain). Higher scores indicate greater perceived pain intensity and therefore a worse outcome.
Time frame: Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3
Cycle distance
An estimated cycle distance will be recorded during each cycling condition by the cycle ergometer in meters
Time frame: Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3
Identified Regulation
Self-reported patient-reported outcome measured using the Identified Regulation 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 identified regulation, reflecting more autonomous motivation and therefore a more favorable outcome.
Time frame: Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3
External Regulation
Self-reported patient-reported outcome measured using the External Regulation 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 externally controlled motivation, reflecting less autonomous motivation and therefore a less favorable outcome.
Time frame: Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3
Amotivation
Self-reported patient-reported outcome measured using the Amotivation 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 amotivation and therefore a less favorable outcome.
Time frame: Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3
Heart rate during cycling
Heart rate is monitored before, during, and immediately after each cycling condition and expressed in beats per minute (bpm) to assess physiological responses and safety.
Time frame: Immediately before, during (up to 20 minutes), and immediately after each cycling condition.
Respiratory rate during cycling
Respiratory rate is monitored before, during, and immediately after each cycling condition and expressed in breaths per minute to assess respiratory responses and safety.
Time frame: Immediately before, during (up to 20 minutes), and immediately after each cycling condition.
Peripheral oxygen saturation during cycling
Peripheral oxygen saturation (SpO₂) is monitored using pulse oximetry before, during, and immediately after each cycling condition and expressed as a percentage (%) to assess oxygenation and safety.
Time frame: Immediately before, during (up to 20 minutes), and immediately after each cycling condition.
Systolic blood pressure during cycling
Systolic blood pressure is measured before, during, and immediately after each cycling condition and expressed in millimeters of mercury (mmHg) to assess cardiovascular responses and safety.
Time frame: Immediately before, during (up to 20 minutes), and immediately after each cycling condition.
Diastolic blood pressure during cycling
Diastolic blood pressure is measured before, during, and immediately after each cycling condition and expressed in millimeters of mercury (mmHg) to assess cardiovascular responses and safety.
Time frame: Immediately before, during (up to 20 minutes), and immediately after each cycling condition.
Mean arterial pressure during cycling
Mean arterial pressure (MAP) is monitored before, during, and immediately after each cycling condition and expressed in millimeters of mercury (mmHg) to assess cardiovascular responses and hemodynamic safety.
Time frame: Immediately before, during (up to 20 minutes), and immediately after each cycling condition.
Adverse events
Minor/major adverse events
Time frame: Assessed during and after each cycling condition
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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