Preserving Ability Through Virtual Exercise (PAVE)

NCT07189286 | Recruiting

• 1 other identifier: 1K01AG090761-01A1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Feasibility Studies

Outcome Measures

Primary Outcomes (4)

• Feasibility: Acceptability of Intervention Measure

  Scores range from 4-20, with higher scores indicating greater acceptability of intervention

  measured at discharge or 7 days post baseline, whichever occurs first

• Feasibility: Appropriateness of Intervention Measure

  Scores range from 4-20, with higher scores indicating greater appropriateness of intervention

  measured at discharge or 7 days post baseline, whichever occurs first

• Feasibility: Simulator Sickness Questionnaire

  Scores range from 0 to 48, with higher score indicating more simulator sickness.

  measured following PAVE participants' first virtual reality session only; baseline only

• 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?"

  measured at discharge or 7 days post baseline, whichever occurs first (PAVE participants only)

Secondary Outcomes (6)

• Physical Activity

  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.

• Physical Activity: Modified Physical Activity Vital Sign

  Measured at baseline and discharge, or 7 days post baseline, whichever occurs first

• Physical Function: Barthel Index

  Measured at baseline and discharge, or 7 days post baseline, whichever occurs first

• Physical Function: UMove Mobility Screen

  Measured at baseline and discharge, or 7 days post baseline, whichever occurs first

• Mental Health: Hospital Anxiety and Depression Scale

  Measured at baseline and discharge, or 7 days post baseline, whichever occurs first

Study Arms (2)

PAVE intervention

EXPERIMENTAL

PAVE participants will be trained to use the virtual reality headset and perform virtual reality physical activity throughout their hospital stay.

Behavioral: PAVE intervention

Education control

ACTIVE COMPARATOR

Education control will receive physical activity education using the NIH "Get Fit for Life" booklet.

Behavioral: Education control

Interventions

PAVE intervention BEHAVIORAL

The 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.

Also known as: virtual reality physical activity

PAVE intervention

Education control BEHAVIORAL

Education control participants will receive and physical activity education using the NIH "Get Fit for Life" booklet.

Education control

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,
• they are unable to follow commands or move their extremities against gravity during the UMove Mobility Assessment,
• they are unable to wear the virtual reality headset,
• they received the education control intervention or PAVE intervention during a prior admission,
• there is an active plan to discharge this patient during day of recruitment or the following day,
• they are on airborne or droplet precautions

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Aging (NIA): collaborator
• The Claude D. Pepper Older Americans Independence Centers: collaborator

Study Sites (1)

UMMC Midtown Campus

Baltimore, Maryland, 21201, United States

RECRUITING

Study Officials

• Brittany Burch, PhD, MSN, RN

  University of Maryland Baltiomre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany Burch, PhD, MSN, RN

CONTACT

4107063770; bfburch@umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participants will not be blinded to the behavioral intervention they are receiving. However, we have designed this study with sequential (blocked) recruitment to minimize bias due to awareness of another group, such as a control group participant being roommates with a PAVE participant as they perform virtual reality physical activity.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This proposed study, Preserving Ability through Virtual Exercise (PAVE), will be a quasi-experimental trial among hospitalized older adults. We plan to recruit the 140 participants from one medical floor, with 70 in the intervention group and 70 in the control group. Recruitment will occur in blocks. First, during the pilot phase, we will recruit 10 intervention participants and then 10 control participants, followed by a temporary pause in recruitment to assess feasibility data and identify any needed protocol refinements. If any refinements are needed, we will submit an IRB modification. Next, we will resume recruitment of 30 intervention and then 30 control participants, followed by 30 intervention and then 30 control participants. Randomizing participants within unit is not feasible because control participants could be exposed to the intervention by observing or interacting with intervention participants (e.g., roommates performing the intervention.

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 23, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: We will actively disseminate the findings of the proposed project via standard peer review mechanisms including the submission of abstracts for poster and podium presentations at scientific meetings and the publication of peer reviewed articles. Data will be stored and maintained on University of Maryland's HIPAA-compliant servers. We will make all de-identified quantitative data publicly available upon publication of the work related to this proposed project, or the end of the project period, whichever comes first. This de-identified data will remain available indefinitely on Zenodo, a generalist repository supported by the NIH.
• Access Criteria: Users of the generalist repository that will store this study's data, Zenodo, can access the individual quantitative data collected from this study, including information related to age, comorbidities, feasibility, physical activity, physical function, and mental health. All direct participant identifiers (e.g., name, date of birth) will be removed from data prior to sharing. We will not share the transcripts from the qualitative individual interviews.

Locations

US (1)