Back to resultsVR vs. Conventional Cycling Exercise for Geriatric Inpatient Physical Activation
Primary Purpose
Inactivity, Physical, Treatment Adherence and Compliance, Hospital Acquired Condition
Status
Not yet recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Virtual reality cycling exercise
Unsupervised stationary cycling exercise
Sponsored by
About this trial
This is an interventional other trial for Inactivity, Physical focused on measuring Virtual Reality, Patient Preference
Eligibility Criteria
Inclusion Criteria:
- Admitted to geriatric ward at Bispebjerg Hospital with an minimum of 3 days (anticipated) left of stay.
- Volunteering
Exclusion Criteria:
- 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
Sites / Locations
- Bispebjerg Geriatric Ward
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Virtual reality cycling exercise
Conventional cycling exercise
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Voluntary exercise duration
How long the patients choose to exercise with vs. with out VR assistance measured on the stationary bikes internal timer
Secondary Outcome Measures
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
Measures of 24 hour physical activity and sedentary behavior
Measured with 24 hour thigh mounted movement sensor
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05123638
Brief Title
VR vs. Conventional Cycling Exercise for Geriatric Inpatient Physical Activation
Official Title
Is Virtual Reality Assisted Cycling Exercise Superior to Conventional Stationary Cycling in Geriatric Patients for Increasing Physical Activity Levels During Hospitalization?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 8, 2021 (Anticipated)
Primary Completion Date
December 22, 2021 (Anticipated)
Study Completion Date
January 7, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inactivity, Physical, Treatment Adherence and Compliance, Hospital Acquired Condition, Sarcopenia
Keywords
Virtual Reality, Patient Preference
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
Since there is only a single investigator conducting this study and due to the nature of exercise intervention, it is impossible to facilitate masking terms in this trial.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality cycling exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional cycling exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Virtual reality cycling exercise
Intervention Description
Daily voluntary cycling for up to 30 minutes with the virtual reality technology
Intervention Type
Behavioral
Intervention Name(s)
Unsupervised stationary cycling exercise
Intervention Description
Daily voluntary cycling for up to 30 minutes (WITHOUT the virtual reality technology)
Primary Outcome Measure Information:
Title
Voluntary exercise duration
Description
How long the patients choose to exercise with vs. with out VR assistance measured on the stationary bikes internal timer
Time Frame
3-14 days
Secondary Outcome Measure Information:
Title
Voluntary exercise amount
Description
How much voluntary cycling work does the participants choose to put out during session calculated from the bikes internal counter and external equations
Time Frame
3-14 days
Title
Measures of 24 hour physical activity and sedentary behavior
Description
Measured with 24 hour thigh mounted movement sensor
Time Frame
3-14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Admitted to geriatric ward at Bispebjerg Hospital with an minimum of 3 days (anticipated) left of stay.
Volunteering
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Søren HL Povlsen
Phone
004528791157
Email
soeren.halkjaer.lohse.povlsen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte Suetta
Organizational Affiliation
CopenAge
Official's Role
Study Director
Facility Information:
Facility Name
Bispebjerg Geriatric Ward
City
Bispebjerg
ZIP/Postal Code
2400
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Søren HL Povlsen, Master
Phone
28791157
Email
soeren.halkjaer.lohse.povlsen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Charlotte Suetta, PhD
Email
charlotte.suetta@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is wanted but not yet premised
Learn more about this trial
VR vs. Conventional Cycling Exercise for Geriatric Inpatient Physical Activation
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