Critical IllnessVRCycling-ICUNCT07894146
Cycling Within an Interactive and Immersive Virtual Environment During Critical Illness: a Patient-centred Approach for Lower Limb Rehabilitation
A study testing Basic-Cycle, TV-Cycle and VR-Cycle in people with Critical Illness, run by KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Basic-Cycle, TV-Cycle and VR-Cycle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Jun 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Daniel Langer, +32 16 34 71 25, daniel.langer@kuleuven.be
About this study
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.
Read more
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.
- Conditions
- Critical Illness
- Being tested
- Basic-Cycle, TV-Cycle, VR-Cycle
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic-CycleBehavioural
Cycling without visual support
TV-CycleBehavioural
Cycling while viewing a cycling route on an external television screen
VR-CycleBehavioural
Cycling within an immersive, interactive virtual reality environment
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Basic-Cycle / TV-Cycle / VR-Cycle | Experimental | Not described Receives: Behavioral: Basic-Cycle; Behavioral: TV-Cycle; Behavioral: VR-Cycle |
| Sequence 2: Basic-Cycle / VR-Cycle / TV-Cycle | Experimental | Not described Receives: Behavioral: Basic-Cycle; Behavioral: TV-Cycle; Behavioral: VR-Cycle |
| Sequence 3: TV-Cycle / VR-Cycle / Basic-Cycle | Experimental | Not described Receives: Behavioral: Basic-Cycle; Behavioral: TV-Cycle; Behavioral: VR-Cycle |
| Sequence 4: TV-Cycle / Basic-Cycle / VR-Cycle | Experimental | Not described Receives: Behavioral: Basic-Cycle; Behavioral: TV-Cycle; Behavioral: VR-Cycle |
| Sequence 5: VR-Cycle / Basic-Cycle / TV-Cycle | Experimental | Not described Receives: Behavioral: Basic-Cycle; Behavioral: TV-Cycle; Behavioral: VR-Cycle |
| Sequence 6: VR-Cycle / TV-Cycle / Basic-Cycle | Experimental | Not described Receives: Behavioral: Basic-Cycle; Behavioral: TV-Cycle; Behavioral: VR-Cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start29 Jun 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within-subject cross-over study design
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Daniel Langer, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894146
- Sponsor's protocol ID
- S71922
- Acronym
- VRCycling-ICU
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cycling Within an Interactive and Immersive Virtual Environment During Critical Illness: a Patient-centred Approach for Lower Limb Rehabilitation
- ClinicalTrials.gov ID
- NCT07894146
- Acronym / sponsor ID
- VRCycling-ICU / S71922
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Within-subject cross-over study design
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Basic-Cycle / TV-Cycle / VR-Cycle | Experimental | Behavioral: Basic-Cycle, Behavioral: TV-Cycle, Behavioral: VR-Cycle |
| Sequence 2: Basic-Cycle / VR-Cycle / TV-Cycle | Experimental | Behavioral: Basic-Cycle, Behavioral: TV-Cycle, Behavioral: VR-Cycle |
| Sequence 3: TV-Cycle / VR-Cycle / Basic-Cycle | Experimental | Behavioral: Basic-Cycle, Behavioral: TV-Cycle, Behavioral: VR-Cycle |
| Sequence 4: TV-Cycle / Basic-Cycle / VR-Cycle | Experimental | Behavioral: Basic-Cycle, Behavioral: TV-Cycle, Behavioral: VR-Cycle |
| Sequence 5: VR-Cycle / Basic-Cycle / TV-Cycle | Experimental | Behavioral: Basic-Cycle, Behavioral: TV-Cycle, Behavioral: VR-Cycle |
| Sequence 6: VR-Cycle / TV-Cycle / Basic-Cycle | Experimental | Behavioral: Basic-Cycle, Behavioral: TV-Cycle, Behavioral: VR-Cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Admission to ICU ≥ 7 days
- ≥ 48h mechanical ventilation
- Expected additional ICU stay ≥ 7 more days
- Adult (≥18y)
- Awake and adequate
Key exclusion criteria (6 listed)
- Significant visual impairments
- Cognitive impairment (MMSE < 20/30)
- Psychotic disorder
- Pregnancy
- Not able to understand Dutch, French or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic-CycleCycling without visual support | Behavioural | Sequence 1: Basic-Cycle / TV-Cycle / VR-Cycle, Sequence 2: Basic-Cycle / VR-Cycle / TV-Cycle, Sequence 3: TV-Cycle / VR-Cycle / Basic-Cycle, Sequence 4: TV-Cycle / Basic-Cycle / VR-Cycle, Sequence 5: VR-Cycle / Basic-Cycle / TV-Cycle, Sequence 6: VR-Cycle / TV-Cycle / Basic-Cycle |
| TV-CycleCycling while viewing a cycling route on an external television screen | Behavioural | Sequence 1: Basic-Cycle / TV-Cycle / VR-Cycle, Sequence 2: Basic-Cycle / VR-Cycle / TV-Cycle, Sequence 3: TV-Cycle / VR-Cycle / Basic-Cycle, Sequence 4: TV-Cycle / Basic-Cycle / VR-Cycle, Sequence 5: VR-Cycle / Basic-Cycle / TV-Cycle, Sequence 6: VR-Cycle / TV-Cycle / Basic-Cycle |
| VR-CycleCycling within an immersive, interactive virtual reality environment | Behavioural | Sequence 1: Basic-Cycle / TV-Cycle / VR-Cycle, Sequence 2: Basic-Cycle / VR-Cycle / TV-Cycle, Sequence 3: TV-Cycle / VR-Cycle / Basic-Cycle, Sequence 4: TV-Cycle / Basic-Cycle / VR-Cycle, Sequence 5: VR-Cycle / Basic-Cycle / TV-Cycle, Sequence 6: VR-Cycle / TV-Cycle / Basic-Cycle |
Primary outcome
Intrinsic Motivation
Time frame: 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.
7 secondary outcomes
Dyspnea
Time frame: Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3
Lower limb fatigue
Time frame: Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3
Pain
Time frame: Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3
Cycle distance
Time frame: Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3
Identified Regulation
Time frame: Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3
External Regulation
Time frame: Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3
Amotivation
Time frame: Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Critical Illness
Recruiting
Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock
Critical Illness, Shock
Recruiting
Characterization and Longitudinal Monitoring of Muscular Phenotype in Patients Admitted to Intensive Care for Sepsis
Sepsis, Myopathy Critical Illness
Not yet recruitingObservational study
Dynamic Inflammatory Changes and Nutritional Risk Scores in ICU Patients Aged 65 Years and Older
Critical Illness, Geriatric Patient
RecruitingObservational study
Establishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care
Critical Illness, Neuropathy
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic-Cycle, TV-Cycle and VR-Cycle in people with Critical Illness, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Langer, Associate professor (+32 16 34 71 25, daniel.langer@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrinsic Motivation (time frame: Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.