Outcomes of Powerbraining: the RHBS Brain and Balance Study of Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in Attention and Auditory Working Memory
研究概览
简要总结
Brief Summary:
Cognition and balance are known to decline during the aging process. Cognitive performance is essential for functional independence and determines whether an individual can perform instrumental daily living activities (e.g., finances, driving, independent living). Balance is critical for participation in everyday life activities. Impaired balance increases fall risk, and subsequent injury increased caregiver dependency and decreased independence.
The purpose of this study is to investigate the outcomes of 24 sessions of online mobility and cognitive training (35 minutes/session, 3x/week, 8-12 weeks) for community-based older adults. The exercise program is progressively challenging and emphasizes balance, cardiovascular conditioning, attention, and working memory. The primary outcomes of interest are cognitive performance and balance changes, with secondary outcomes relating to self-efficacy, resilience, and physical activity.
详细描述
Protocol Overview: Subjects will be recruited from the greater Washington D.C. metro area. Individuals interested in participating as subjects will complete initial verbal screening to determine eligibility for inclusion. Those subjects who volunteer to participate will then be consented and enrolled for participation if exclusion and inclusion criteria are met.
Visit 1: (~120 minutes) Participants meeting study rationale and voluntarily agree to participate will receive a standardized email generated through the Research Electronic Data Capture (REDcap) platform. The email will contain a Zoon videoconference link to complete cognitive assessments (described below) and virtual balance tests (described below) with a research assistant. That email will also contain a second link to complete all surveys through the REDcap portal. Only one selected member of the research team will have an identification key connecting personally identifiable information to returned surveys. Cognitive assessments will be completed online using REDcap and Q-global Pearson, with a member of the research team providing verbal instruction via videoconference. After cognitive assessment completion, participants will perform the virtual balance tests. A team member will oversee setup via videoconference to ensure the environment's safety and administer the test. Participants will receive login instructions and access code to the virtual training sessions with POWER BRAINing.
Visits 2-25: (~35 minutes each) Participants will perform training videos at their convenience two to three times per week for 8-12 weeks for a total of 24 sessions. Participants will receive a weekly email and/or phone call from research staff to check safety, provide encouragement, and answer any questions.
Visit 26: (~120 minutes) Subjects will repeat the same testing procedures, in the same order, as they did in visit 1.
Study Procedures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •55 - 80 years old
- •Ability to take at least 4 steps without an assistive device
- •Ability to speak English
排除标准
- •Inability to ambulate at least 4 steps without assistive device
- •Uncontrolled cardiovascular, pulmonary, neurological, or metabolic disease which may impact the ability to exercise or in which exercise is contraindicated
- •Cognitive or psychiatric impairment precluding informed consent or ability to following instructions
结局指标
主要结局
Change in Attention and Auditory Working Memory
时间窗: pre and post 8-week intervention protocol
(A) as measured by the Digit Span subset of Wechsler Adult Intelligence Scale- 4th Edition (WAIS-IV); Each correct response is worth 1 point, with a maximum of 14 for each sub-score and for a total score of 24. Higher scores are indicative of better outcome. (B) as measured by Letter-Number Sequencing, each correct response is worth 1 point, with a maximum total score of 21. Higher scores are indicative of better outcome.
Change in Static Balance in a Standing Position
时间窗: pre and post 8-week intervention protocol
as measured by the Four-Stage Balance Test
Change in Information Processing Speed
时间窗: pre and post 8-week intervention protocol
as measured by the Simple and Choice Reaction Times
Change in Visual Spatial Working Memory
时间窗: pre and post 8-week intervention protocol
as measured by the Spatial Addition Subset of Wechsler Memory Scale- 4th Edition (WMS-IV); This is a 24-item assessment, each correct response is worth 1 point for a total score of 24. Higher scores are indicative of better outcome.
次要结局
- Change in Level of Physical Activity(pre and post 8-week intervention protocol)
- Change in Lower Extremity Kinematic parameters(pre and post 8-week intervention protocol)
- Change in Leg Strength(pre and post 8-week intervention protocol)
- Change in Resilience(pre and post 8-week intervention protocol)
- Change in Postural Sway(pre and post 8-week intervention protocol)
- Change in Confidence in Performing Various Activities(pre and post 8-week intervention protocol)