Preserving Ability Through Virtual Exercise (PAVE): An Intervention to Increase the Physical Activity of Hospitalized Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Feasibility: Acceptability of Intervention Measure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PAVE intervention
PAVE participants will be trained to use the virtual reality headset and perform virtual reality physical activity throughout their hospital stay.
干预措施: PAVE intervention (Behavioral)
Education control
Education control will receive physical activity education using the NIH "Get Fit for Life" booklet.
干预措施: Education control (Behavioral)
结局指标
主要结局
Feasibility: Acceptability of Intervention Measure
时间窗: measured at discharge or 7 days post baseline, whichever occurs first
Scores range from 4-20, with higher scores indicating greater acceptability of intervention
Feasibility: Appropriateness of Intervention Measure
时间窗: measured at discharge or 7 days post baseline, whichever occurs first
Scores range from 4-20, with higher scores indicating greater appropriateness of intervention
Feasibility: Simulator Sickness Questionnaire
时间窗: measured following PAVE participants' first virtual reality session only; baseline only
Scores range from 0 to 48, with higher score indicating more simulator sickness.
Feasibility: Qualitative Interviews
时间窗: measured at discharge or 7 days post baseline, whichever occurs first (PAVE participants only)
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?"
次要结局
- 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(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)
- Brief Resilience Scale(Measured at baseline and discharge, or 7 days post baseline, whichever occurs first)
研究者
Brittany Burch
Assistant Professor
University of Maryland, Baltimore