NCT05123638

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

November 8, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2022

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

1 month

First QC Date

November 6, 2021

Last Update Submit

November 6, 2021

Conditions

Keywords

Virtual RealityPatient Preference

Outcome Measures

Primary Outcomes (1)

  • Voluntary exercise duration

    How long the patients choose to exercise with vs. with out VR assistance measured on the stationary bikes internal timer

    3-14 days

Secondary Outcomes (2)

  • Voluntary exercise amount

    3-14 days

  • Measures of 24 hour physical activity and sedentary behavior

    3-14 days

Study Arms (2)

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.

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.

Behavioral: Unsupervised stationary cycling exercise

Interventions

Daily voluntary cycling for up to 30 minutes with the virtual reality technology

Virtual reality cycling exercise

Daily voluntary cycling for up to 30 minutes (WITHOUT the virtual reality technology)

Conventional cycling exercise

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Admitted to geriatric ward at Bispebjerg Hospital with an minimum of 3 days (anticipated) left of stay.
  • Volunteering

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Geriatric Ward

Bispebjerg, 2400, Denmark

Location

MeSH Terms

Conditions

Sedentary BehaviorTreatment Adherence and ComplianceIatrogenic DiseaseSarcopeniaPatient Preference

Condition Hierarchy (Ancestors)

BehaviorHealth BehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and SymptomsPatient Satisfaction

Study Officials

  • Charlotte Suetta

    CopenAge

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

November 6, 2021

First Posted

November 17, 2021

Study Start

November 8, 2021

Primary Completion

December 22, 2021

Study Completion

January 7, 2022

Last Updated

November 17, 2021

Record last verified: 2021-11

Locations