Preserving Ability Through Virtual Exercise (PAVE)
Purpose
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.
Condition
- Feasibility Studies
Eligibility
- Eligible Ages
- Over 55 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- in the last 72 hours, they were admitted to the medical floor that is the setting of the study, 2. are 55 years or older, 3. their bedside nurse approves their physical activity participation in this study
Exclusion Criteria
- they are unable to pass the Evaluation to Sign Consent Measure, 2. they score 20 or lower on the Montreal Cognitive Assessment Basic, 3. they have an admitting diagnosis that could be worsened through virtual reality exercise, 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, 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, 8. there is an active plan to discharge this patient during day of recruitment or the following day, 9. they are on airborne or droplet precautions
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- 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.
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
- Masking Description
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PAVE intervention |
PAVE participants will be trained to use the virtual reality headset and perform virtual reality physical activity throughout their hospital stay. |
|
|
Active Comparator Education control |
Education control will receive physical activity education using the NIH "Get Fit for Life" booklet. |
|
Recruiting Locations
Baltimore, Maryland 21201
More Details
- Status
- Recruiting
- Sponsor
- University of Maryland, Baltimore
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.