Preserving Ability Through Virtual Exercise (PAVE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PAVE intervention, Education control.
- Who it may be relevant to
- Registry conditions: Feasibility Studies. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Preserving Ability Through Virtual Exercise (PAVE): An Intervention to Increase the Physical Activity of Hospitalized Older Adults
Overview
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 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.
Interventions
- Behavioral PAVE intervention
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 i - Behavioral Education control
Education control participants will receive and physical activity education using the NIH "Get Fit for Life" booklet.
Primary outcome measures
- Feasibility: Acceptability of Intervention Measure [Time frame: measured at discharge or 7 days post baseline, whichever occurs first]
- Feasibility: Appropriateness of Intervention Measure [Time frame: measured at discharge or 7 days post baseline, whichever occurs first]
- Feasibility: Simulator Sickness Questionnaire [Time frame: measured following PAVE participants' first virtual reality session only; baseline only]
- Feasibility: Qualitative Interviews [Time frame: measured at discharge or 7 days post baseline, whichever occurs first (PAVE participants only)]
Secondary outcome measures (6)
- Physical Activity [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.]
- Physical Activity: Modified Physical Activity Vital Sign [Time frame: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first]
- Physical Function: Barthel Index [Time frame: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first]
- Physical Function: UMove Mobility Screen [Time frame: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first]
- Mental Health: Hospital Anxiety and Depression Scale [Time frame: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first]
- Brief Resilience Scale [Time frame: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- UMMC Midtown Campus — Baltimore
Identifiers
NCT: NCT07189286 · 1K01AG090761-01A1 · 1K01AG090761-01A1