Feasibility and Acceptability of Virtual Reality-based Mindful Movement Therapy for Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Treatment acceptability
研究概览
简要总结
The current proposal aims to 1) develop a technical platform and implementation plan for the delivery of a virtual reality-based mindful movement therapy (VR-MMT) protocol for older adults; and 2) conduct a clinical trial to examine the feasibility and preliminary efficacy of an 8-week, 16-session module VR-MMT intervention for this population. The findings of this study will help us to identify engagement barriers and refine the intervention contents as well as the study protocol necessary for the preparation of grant applications to conduct a controlled clinical trial. This study is innovative and high impact as this is the first study to examine the feasibility and preliminary efficacy of a VR-MMT intervention that could potentially ameliorate cognitive and mobility decline and promote psychological wellbeing in older adults by combining a widely accessible technology and creative embodiment-based approach.
详细描述
Age-related cognitive decline is a significant public health issue. Despite the benefit of regular physical activity in preserving cognitive function and overall health and wellbeing, approximately 30% of older adults are physically inactive due to a lack of motivation and other engagement barriers. Further, social isolation and loneliness are common in older adults which are associated with an increased risk of developing Alzheimer's disease (AD) and dementia. A combination of physical and cognitive training appears to be effective to improve cognitive function in older adults experiencing cognitive deterioration. Growing evidence suggests virtual reality(VR) is a promising tool to improve cognitive functioning in older adults. We have developed a novel virtual reality-based mindful movement therapy (VR-MMT) program for older adults that combines VR games, multisensory and cognitive stimulation, hand-eye and full body coordination, creative processes, expressive movement, mindfulness practice, and social connectedness. The current proposal aims to 1) develop a technical platform and implementation plan for the delivery of a VR-MMT protocol for older adults; and 2) conduct a clinical trial to examine the feasibility and preliminary efficacy of an 8-week, 16-session module VR-MMT intervention for this population. The findings of this study will help us to identify engagement barriers and refine the intervention contents as well as the study protocol necessary for the preparation of grant applications to conduct a controlled clinical trial. As this is the first study to examine the feasibility and preliminary efficacy of a VR-MMT intervention that could potentially ameliorate cognitive and mobility decline and promote psychological wellbeing in older adults by combining a widely accessible technology and creative embodiment-based approach, it meets the definition of "innovative, high impact" research. Our specific aims include:
Aim 1: To develop (a) a technical platform and (b) an implementation plan for the delivery of a VR-MMT intervention for older adults. Technical development and implementation planning will be guided by the expert project team with key input from community stakeholders.
Aim 2: To conduct a clinical feasibility trial to examine the safety, feasibility, and preliminary efficacy (primary outcomes: cognitive function, psychological wellbeing, physical activity participation, secondary outcomes: mobility performance, loneliness, self-efficacy) of an 8-week VR-MMT intervention for older adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be age 65 or older at the time of informed consent.
- •Able to move and stand without assistance
- •Subjects must be proficient in spoken and written English for consenting as well as for study participation
- •Subjects with medical conditions must be stable for these conditions. Stable control on medication is acceptable.
- •Subject must have normal visual acuity (or corrected to normal) and normal color vision as indicated by self-report.
- •Subject must have adequate hearing acuity as indicated by self-report.
排除标准
- •Existing diagnosis of a neurodegenerative disorder (e.g., Alzheimer's Disease, Lewy Body Dementia, Frontal-Temporal Dementia).
- •Prior diagnosis that might impact cognition and movement abilities including: cardiovascular or respiratory illness or injury, substance abuse, schizophrenia, bipolar disorder, or other neurological diseases (e.g., epilepsy, Parkinson's disease, seizure disorder).
- •Affirmative answer to any Physical Activity Readiness Questionnaire for 70+ year-old adults (PAR-Q-70+) questionnaire.
结局指标
主要结局
Treatment acceptability
时间窗: Post intervention (Week 6)
Treatment Evaluation Inventory Short Form (post-intervention only) is a 9-item measure of the perceived acceptability of behavioral treatments. Items are rated on a 5-point scale with the anchor points 1 (strongly disagree) and 5 (strongly agree). Higher score meaning greater levels of treatment acceptability.
Treatment adherence
时间窗: Throughout the intervention (week 1-week 6)
We will log participants' session attendance to track treatment adherence
Treatment satisfaction
时间窗: Post intervention (Week 6)
Usefulness, Satisfaction, and Ease of Use Questionnaire (post-intervention only) is a 30-item instrument that examines four dimensions of usability: usefulness, ease of use, ease of learning, and satisfaction. Each question is rated on a seven-point scale with the anchor points 1 (strongly disagree) and 7 (strongly agree). There are also two open-ended response questions asking the user to list the most negative aspects and the most positive aspects. All items are summed to give a total score, with higher scores indicating greater usability.
Qualitative feedback
时间窗: Post intervention (within 1-2 weeks after the conclusion of the 6-week intervention)
A semi-guided individual interview (30 min) will be conducted upon the completion of the intervention to learn about participants' experience of participating in the study, perceived benefits, perceived barriers, and suggestions for improvement.
Safety
时间窗: Throughout the intervention (week 1-week 6)
We will log adverse event to assess safety of the intervention
次要结局
- The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)(Pre and post intervention(Week 0 and Week 6))
- Montreal Cognitive Assessment (MoCA)(Pre and post intervention (Week 0 and Week 6))
- Physical Performance Battery (SPPB)(Pre and post intervention(Week 0 and Week 6))
- Trail making test(Pre and post intervention(Week 0 and Week 6))
- Physical Activity Scale for the Elderly (PASE)(Pre and post intervention(Week 0 and Week 6))
- General Self-Efficacy Scale(Pre and post intervention(Week 0 and Week 6))
- Positive Affect and Negative Affect Scale (PANAS)(Pre and post intervention(Week 0 and Week 6))
研究者
Minjung Shim, PhD
Assistant Professor
Drexel University