Preserving Ability Through Virtual Exercise (PAVE)

Not Applicable

Not yet recruiting

• Conditions: Feasibility Studies

• Registration Number: NCT07189286
• Lead Sponsor: University of Maryland, Baltimore

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.

Detailed Description

Older adults (≥60 years) experience multi-level barriers to physical activity when hospitalized. Patient level barriers to physical activity when hospitalized include tethers (e.g., foley catheters, intravenous infusions), symptoms of their acute illness (e.g., pain, fatigue), low self-efficacy to perform physical activity, and a perception that they should remain on bedrest when hospitalized. Interpersonal barriers to physical activity, highlighted during this post pandemic environment, include staffing shortages and increased patient acuity, which can force nurses to prioritize other critical tasks over the physical activity of their patients. Environmental barriers to physical activity include bed alarms and a hospital climate that is hyper focused on the incorrect assumption that physical activity increases fall risk among hospitalized older adults.

This lack of physical activity in the hospital generates major personal and societal costs. Each day a patient spends in the hospital increases their risk of functional decline and loss of muscle mass, which older adults can find difficult or impossible to restore in the post-acute period. Hospital associated deconditioning increases the length of hospital stays, and increases the susceptibility of patients to delirium, falls, and re-admission. Such complications ultimately increase health care costs. Therefore, there is a significant unmet need to identify strategies to increase older patients' physical activity while minimizing staff burden.

The overall objective of this proposed project is to explore the feasibility and preliminary efficacy of a virtual reality physical activity intervention to engage older adults in physical activity and maintain physical function during their hospital stay. This quasi-experimental study has two aims.

Primary) Aim 1: Using the NIH Behavior Change consortium guidelines, the Acceptability/Appropriateness of Intervention Measure, the Simulator Sickness Questionnaire, and semi-structured individual interviews, determine the feasibility of a virtual reality intervention among hospitalized older adults.

Aim 2: Test the preliminary efficacy of the PAVE intervention on 1) time spent in physical activity during the hospital stay, 2) maintenance of physical function, and 3) maintenance of mental health, compared to the education only control group.

Hypothesis 2.1. Patients exposed to the PAVE intervention will demonstrate more time spent in physical activity (MotionWatch, physical activity diary) during their hospital stay, when compared to those exposed to the education control, controlling for appropriate covariates.

Hypothesis 2.2. Patients exposed to the PAVE intervention will better maintain their physical function throughout their hospital stay (Barthel Index, UMove), when compared to those exposed to the education control, controlling for appropriate covariates.

Hypothesis 2.3. Patients exposed to the PAVE intervention will better maintain their mental health throughout their hospital stay (Hospital Anxiety and Depression Scale), when compared to those exposed to the education control, controlling for appropriate covariates.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-09
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-23
• Last Update Posted: 2025-09-23
• Study Start: 2026-01-01
• Primary Completion: 2029-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. are admitted to the medical floor and,
2. are 60 years or older

Exclusion Criteria

1. they are unable to pass the Evaluation to Sign Consent Measure,
2. they score 3 or lower on the Mini-Cog Assessment,
3. they have a diagnosis that could be worsened through virtual reality exercise (e.g., nausea, syncope, vertigo, upper extremity fractures/sprain/strain),
4. 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, or
5. they are unable to follow commands or move their extremities against gravity during the UMove Mobility Assessment
6. they received the education control intervention during a prior admission

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Feasibility: Acceptability of Intervention Measure	measured at 3 days post-baseline, and discharge or 7 days later, whichever occurs first	Scores range from 4-20, with higher scores indicating greater acceptability of intervention
Feasibility: Appropriateness of Intervention Measure	measured at 3 days post-baseline, and discharge or 7 days later, whichever occurs first	Scores range from 4-20, with higher scores indicating greater appropriateness of intervention
Feasibility: Simulator Sickness Questionnaire	measured at 3 days post-baseline, and discharge or 7 days later, whichever occurs first	Scores range from 0 to 48, with higher score indicating more simulator sickness.
Feasibility: Qualitative Interviews	once at discharge or 7 days post baseline data collection, whichever occurs first	The interviews will include the following three 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?", and (3) "How could this virtual reality physical activity intervention be improved?"

Secondary Outcome Measures

Name	Time	Method
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.	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).
Physical Function: Barthel Index	measured at baseline, 3 days post-baseline, and discharge or 7 days later, whichever occurs first	Barthel Index. Scores range from 0-100, with higher scores indicating greater independence.
Physical Function: UMove Mobility Screen	measured at baseline, 3 days post-baseline, and discharge or 7 days later, whichever occurs first	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.
Mental Health: Hospital Anxiety and Depression Scale	measured at baseline, 3 days post-baseline, and discharge or 7 days later, whichever occurs first.	Hospital Anxiety and Depression Scale: Scores range from 0-21, with higher score indicating greater mental illness.

Trial Locations

Locations (1)

UMMC Midtown Campus; 🇺🇸 Baltimore, Maryland, United States