Preserving Ability Through Virtual Exercise (PAVE)
ConditionFeasibility Studies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorUniversity of Maryland, Baltimore
About this trial
Each day in the hospital leads to functional decline and loss of muscle mass, which older adults can find difficult or impossible to restore in the post-acute period. The overall objective of this proposed project is to explore the feasibility and preliminary efficacy of a virtual reality physical activity intervention at helping older adults engage in physical activity and maintain physical function and mental health during their hospital stay. As virtual reality technology becomes more affordable and ubiquitously available across the world, this study will demonstrate how this technology could be leveraged to maintain the function of older adults in the hospital.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
in the last 72 hours, they were admitted to the medical floor that is the setting of the study,
are 55 years or older,
their bedside nurse approves their physical activity participation in this study
Disqualifiers
they are unable to pass the Evaluation to Sign Consent Measure,
they score 20 or lower on the Montreal Cognitive Assessment Basic,
they have an admitting diagnosis that could be worsened through virtual reality exercise,
they have an attached medical device that decreases the safety of physical activity such as a nasogastric tube or continuous fluids running through a PICC line that cannot be paused,
Trial design
Design model
Sequential
Treatments tested in this trial
PAVE intervention
BehavioralThe commercial virtual reality app that will be used for the intervention, Supernatural, provides participants a trainer as they use their arms and legs (e.g., seated knee strikes) to smash targets to 500+ musical tracks. In this manner, this study employs fun as a motivator for exercise commencement and adherence while hospitalized. The research assistant will implement the intervention using the three-step approach including: (1) patient mobility screen, (2) orientation to the technology and intervention, and (3) ongoing assessment, adaptation, and motivation.
Education control
BehavioralEducation control participants will receive and physical activity education using the NIH "Get Fit for Life" booklet.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: PAVE interventionExperimental treatment 1 intervention
Group B: Education controlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility: Acceptability of Intervention Measure
Scores range from 4-20, with higher scores indicating greater acceptability of intervention
Time frame
measured at discharge or 7 days post baseline, whichever occurs first2
Feasibility: Appropriateness of Intervention Measure
Scores range from 4-20, with higher scores indicating greater appropriateness of intervention
Time frame
measured at discharge or 7 days post baseline, whichever occurs first3
Feasibility: Simulator Sickness Questionnaire
Scores range from 0 to 48, with higher score indicating more simulator sickness.
Time frame
measured following PAVE participants' first virtual reality session only; baseline only4
Feasibility: Qualitative Interviews
The interviews will include the following four questions: (1) "What did you like best about the virtual reality physical activity intervention?", (2) "What did you like least about the virtual reality physical activity intervention?", (3) "How, if at all, did participating in the virtual reality exercises affect the way you coped with challenges during your hospital stay?" and (4) "How could this virtual reality physical activity intervention be improved?"
Time frame
measured at discharge or 7 days post baseline, whichever occurs first (PAVE participants only)Secondary outcomes
1
Physical Activity
The MotionWatch8 is a lightweight, wrist-worn activity monitoring device with a battery that lasts approximately one month. The MotionWatch8 contains a valid and reliable accelerometer, which records physical movement of the wrist providing a close correlation to whole body movement (1-minute epochs, 50 Hz). We will quantify counts of activity into sedentary, light, moderate, and vigorous activity per day (as defined by Landry and colleagues, 2015, Front Aging Neurosci).
Time frame
At baseline enrollment, we will apply the MotionWatch8 to participants' wrists. At discharge, or 7 days after baseline, whichever occurs first, we will remove the MotionWatch8.2
Physical Activity: Modified Physical Activity Vital Sign
The modified Physical Activity Vital sign measures patients' self-report participation in physical activity. The 6 items gather if (yes/no) activity was performed, duration (in minutes), and intensity (ordinal 0-10, with higher scores indicating higher intensity) for movement and strength based activities within the last 24 hours.
Time frame
Measured at baseline and discharge, or 7 days post baseline, whichever occurs first3
Physical Function: Barthel Index
Barthel Index. Scores range from 0-100, with higher scores indicating greater independence.
Time frame
Measured at baseline and discharge, or 7 days post baseline, whichever occurs first4
Physical Function: UMove Mobility Screen
The UMove Mobility Scale is a clinical screening tool designed to help healthcare providers assess a patient's functional mobility and determine safe strategies for out-of-bed movement and ambulation. While there is no fixed numerical range, patients are categorized into mobility levels 1-5.
Time frame
Measured at baseline and discharge, or 7 days post baseline, whichever occurs firstSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Maryland, Baltimore
Lead sponsor
National Institute on Aging (NIA)
Collaborator
The Claude D. Pepper Older Americans Independence Centers
Collaborator
Source ClinicalTrials.gov