Preserving Ability Through Virtual Exercise (PAVE)

University of Maryland Baltimore (UMB)

Status: Not yet enrolling

Conditions: Feasibility Studies

Treatments: Behavioral: Education control; Behavioral: PAVE intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07189286

1K01AG090761-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 and mental health 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, Modified Physical Activity Vital Sign) 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, Brief Reslience Scale), when compared to those exposed to the education control, controlling for appropriate covariates.

Enrollment: 140 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. in the last 48 hours, they were admitted to the medical floor that is the setting of the study,
2. are 60 years or older,
3. their bedside nurse approves their physical activity participation in this study

Exclusion criteria

1. they are unable to pass the Evaluation to Sign Consent Measure,
2. they score 23 or lower on the Montreal Cognitive 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 are unable to wear the virtual reality headset
7. they received the education control intervention or PAVE intervention during a prior admission

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

PAVE intervention

Experimental group

Description:

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

Treatment:

Behavioral: PAVE intervention

Education control

Active Comparator group

Description:

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

Treatment:

Behavioral: Education control