Inactivity, PhysicalNCT05123638
VR vs. Conventional Cycling Exercise for Geriatric Inpatient Physical Activation
A study testing Virtual reality cycling exercise and Unsupervised stationary cycling exercise in people with Inactivity, Physical and Treatment Adherence and Compliance, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to investigate whether virtual reality assisted stationary cycling exercise results in more physical activity than conventional unsupervised stationary cycling exercise. Physical activity levels are reported for both exercise duration and volume and non-exercise activity. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Inactivity, Physical, Treatment Adherence and Compliance, Hospital Acquired Condition
- What is being tested?
- Virtual reality cycling exercise and Unsupervised stationary cycling exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Nov 2021to 7 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Admitted to geriatric ward at Bispebjerg Hospital with an minimum of 3 days (anticipated) left of stay.
- Volunteering
Who cannot join
- Unable to be easily mobilized by training staff.
- Unable to perform the stationary cycling exercise modality.
- Lack of Danish speaking and reading skills.
- Lack of senses (blind, deff pr heavily hearing impaired).
- Suffering from delirium, vertigo or dementia beyond a moderate degree.
- Judged medically contraindicated by therapeutic, medical or care staff
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg Geriatric Ward
Bispebjerg, 2400
Søren HL Povlsen, Master, 28791157, soeren.halkjaer.lohse.povlsen@regionh.dk
Charlotte Suetta, PhD, charlotte.suetta@regionh.dk
About this study
Official title: Is Virtual Reality Assisted Cycling Exercise Superior to Conventional Stationary Cycling in Geriatric Patients for Increasing Physical Activity Levels During Hospitalization?
The aim of this study is to investigate whether virtual reality assisted stationary cycling exercise results in more physical activity than conventional unsupervised stationary cycling exercise. Physical activity levels are reported for both exercise duration and volume and non-exercise activity.
- Conditions
- Inactivity, Physical, Treatment Adherence and Compliance, Hospital Acquired Condition, Sarcopenia
- Being tested
- Virtual reality cycling exercise, Unsupervised stationary cycling exercise
- Keywords
- Virtual Reality, Patient Preference
- Medical subject headings
- Sedentary Behavior, Treatment Adherence and Compliance, Iatrogenic Disease, Sarcopenia, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality cycling exerciseDevice
Daily voluntary cycling for up to 30 minutes with the virtual reality technology
Unsupervised stationary cycling exerciseBehavioural
Daily voluntary cycling for up to 30 minutes (WITHOUT the virtual reality technology)
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality cycling exercise | Experimental | These patient participants will receive 1 session of unsupervised stationary cycling exercise with the SYNCSENSE VR-technology every weekday of participation and be allowed up to 30min of voluntary exercise pr. session. Receives: Device: Virtual reality cycling exercise |
| Conventional cycling exercise | Active comparator | These patient participants will receive 1 session of unsupervised stationary cycling exercise on every weekday of participation and be allowed up to 30min of voluntary exercise pr. session. Receives: Behavioral: Unsupervised stationary cycling exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voluntary exercise duration
How long the patients choose to exercise with vs. with out VR assistance measured on the stationary bikes internal timer
Measured: 3-14 days
Secondary outcomes (2)
Voluntary exercise amount
How much voluntary cycling work does the participants choose to put out during session calculated from the bikes internal counter and external equations
Measured: 3-14 days
Measures of 24 hour physical activity and sedentary behavior
Measured with 24 hour thigh mounted movement sensor
Measured: 3-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start8 Nov 2021 (estimated)
- Primary completion22 Dec 2021 (estimated)
- Study completion7 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inactivity, PhysicalStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stratified randomization (based os Cumulated-Ambulation Score of 6 vs. \<6) of geriatric inpatients to either VR assisted stationary cycling exercise or conventional stationary cycling exercise.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Suetta, Bispebjerg Hospital
- Investigators
- Charlotte Suetta, Study director, CopenAge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123638
- Sponsor's protocol ID
- VR+Cycling
- Status last verified
- Nov 2021
- First submitted
- 6 Nov 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is wanted but not yet premised
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Virtual Reality Assisted Cycling Exercise Superior to Conventional Stationary Cycling in Geriatric Patients for Increasing Physical Activity Levels During Hospitalization?
- ClinicalTrials.gov ID
- NCT05123638
- Acronym / sponsor ID
- VR+Cycling
- Conditions
- Inactivity, Physical, Treatment Adherence and Compliance, Hospital Acquired Condition, Sarcopenia
- Keywords
- Virtual Reality, Patient Preference
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 8 Nov 2021 (estimated)
- Primary completion
- 22 Dec 2021 (estimated)
- Study completion
- 7 Jan 2022 (estimated)
- First posted
- 17 Nov 2021 (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.
The aim of this study is to investigate whether virtual reality assisted stationary cycling exercise results in more physical activity than conventional unsupervised stationary cycling exercise. Physical activity levels are reported for both exercise duration and volume and non-exercise activity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stratified randomization (based os Cumulated-Ambulation Score of 6 vs. <6) of geriatric inpatients to either VR assisted stationary cycling exercise or conventional stationary cycling exercise.
| Arm | Type | Receives |
|---|---|---|
| Virtual reality cycling exercise | Experimental | Device: Virtual reality cycling exerciseThese patient participants will receive 1 session of unsupervised stationary cycling exercise with the SYNCSENSE VR-technology every weekday of participation and be allowed up to 30min of voluntary exercise pr. session. |
| Conventional cycling exercise | Active comparator | Behavioral: Unsupervised stationary cycling exerciseThese patient participants will receive 1 session of unsupervised stationary cycling exercise on every weekday of participation and be allowed up to 30min of voluntary exercise pr. session. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Admitted to geriatric ward at Bispebjerg Hospital with an minimum of 3 days (anticipated) left of stay.
- Volunteering
Key exclusion criteria (6 listed)
- Unable to be easily mobilized by training staff.
- Unable to perform the stationary cycling exercise modality.
- Lack of Danish speaking and reading skills.
- Lack of senses (blind, deff pr heavily hearing impaired).
- Suffering from delirium, vertigo or dementia beyond a moderate degree.
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 |
|---|---|---|
| Virtual reality cycling exerciseDaily voluntary cycling for up to 30 minutes with the virtual reality technology | Device | Virtual reality cycling exercise |
| Unsupervised stationary cycling exerciseDaily voluntary cycling for up to 30 minutes (WITHOUT the virtual reality technology) | Behavioural | Conventional cycling exercise |
Primary outcome
Voluntary exercise duration
Time frame: 3-14 days
How long the patients choose to exercise with vs. with out VR assistance measured on the stationary bikes internal timer
2 secondary outcomes
Voluntary exercise amount
Time frame: 3-14 days
Measures of 24 hour physical activity and sedentary behavior
Time frame: 3-14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Individual participant dataSharing planned: Undecided. It is wanted but not yet premised
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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. This study is not recruiting at the moment.
Charlotte Suetta study director
CopenAge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality cycling exercise and Unsupervised stationary cycling exercise in people with Inactivity, Physical and Treatment Adherence and Compliance, run by Bispebjerg Hospital at 1 site in Denmark.
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 2 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: status not confirmed, as of the sponsor's last update on 17 Nov 2021. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Søren HL Povlsen (004528791157, soeren.halkjaer.lohse.povlsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voluntary exercise duration (time frame: 3-14 days). 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 17 Nov 2021.