- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05123638
VR vs. Conventional Cycling Exercise for Geriatric Inpatient Physical Activation
November 6, 2021 updated by: Charlotte Suetta, Bispebjerg Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Søren HL Povlsen
- Phone Number: 004528791157
- Email: soeren.halkjaer.lohse.povlsen@regionh.dk
Study Locations
-
-
-
Bispebjerg, Denmark, 2400
- Bispebjerg Geriatric Ward
-
Contact:
- Søren HL Povlsen, Master
- Phone Number: 28791157
- Email: soeren.halkjaer.lohse.povlsen@regionh.dk
-
Contact:
- Charlotte Suetta, PhD
- Email: charlotte.suetta@regionh.dk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Virtual reality cycling exercise
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.
|
Daily voluntary cycling for up to 30 minutes with the virtual reality technology
|
|
ACTIVE_COMPARATOR: Conventional cycling exercise
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.
|
Daily voluntary cycling for up to 30 minutes (WITHOUT the virtual reality technology)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3-14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Voluntary exercise amount
Time Frame: 3-14 days
|
How much voluntary cycling work does the participants choose to put out during session calculated from the bikes internal counter and external equations
|
3-14 days
|
|
Measures of 24 hour physical activity and sedentary behavior
Time Frame: 3-14 days
|
Measured with 24 hour thigh mounted movement sensor
|
3-14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Charlotte Suetta, CopenAge
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
November 8, 2021
Primary Completion (ANTICIPATED)
December 22, 2021
Study Completion (ANTICIPATED)
January 7, 2022
Study Registration Dates
First Submitted
November 6, 2021
First Submitted That Met QC Criteria
November 6, 2021
First Posted (ACTUAL)
November 17, 2021
Study Record Updates
Last Update Posted (ACTUAL)
November 17, 2021
Last Update Submitted That Met QC Criteria
November 6, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VR+Cycling
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
It is wanted but not yet premised
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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