A Pilot to Evaluate the Feasibility and Efficacy of a Multifaceted Rehabilitation Intervention
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change from Baseline Late-Life Function and Disability Instrument at 6 weeks
研究概览
简要总结
The goal of this study is to evaluate the efficacy of multifaceted rehabilitation program in Veterans 65 years and older. This study will also examine the neuromuscular and cognitive attributes that contribute to clinically meaningful improvements in mobility; and determine whether a novel mode of cognitive training can enhance cognition among mobility limited primary care Veterans 65 years and older.
详细描述
This study is a randomized control pilot study. All participants will receive rehabilitative exercise addressing mobility skills. In addition, one group will be will receive additional cognitive training. Randomization is stratified according to screening mobility and cognitive score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65-90
- •History of fall in the past year OR difficulty or task modification with climbing one flight of stairs or walking ½ mile (6 blocks)
- •Community Dwelling
- •Ability to speak and understand English
排除标准
- •Presence of a terminal disease (e.g. receiving hospice services, metastatic cancer
- •Major medical problem interfering with safe and successful testing (i.e. history of hip replacement with recurrent dislocation; uncontrolled hypertension, use of supplemental oxygen
- •Myocardial infarction or major surgery in previous 3 months
- •Planned major surgery (e.g. joint replacement)
- •Baseline Short Physical Performance Battery Score <4 or >10
- •Modified Mini Mental Status Examination score of ≤77 out of 100
- •Inability to safely complete the 400 meter walk test
研究组 & 干预措施
Functional Power + Cognitive Training
Training sessions began with approximately 30 minutes of cognitive training using a desktop computer followed by 40 minutes of functional power training.
干预措施: InVEST: Increased Velocity Exercise Specific to Task (Other)
Functional Power + Cognitive Training
Training sessions began with approximately 30 minutes of cognitive training using a desktop computer followed by 40 minutes of functional power training.
干预措施: TAPAT: Tonic and Phasic Alertness Training (Other)
Functional Power Training
Training sessions began with 40 minutes of functional power training.
干预措施: InVEST: Increased Velocity Exercise Specific to Task (Other)
结局指标
主要结局
Change from Baseline Late-Life Function and Disability Instrument at 6 weeks
时间窗: Baseline, 6 weeks
Function domain and the advanced and basic lower extremity function sub-domains of the Late-Life Function and Disability Instrument
次要结局
- Change from Baseline Figure-of-8 Performance 6 weeks(Baseline, 6 weeks)
- Change from Baseline Cognitive Performance at 6 weeks(Baseline, 6 weeks)
- Change from Baseline 400 Meter Walk Test at 6 weeks(Baseline, 6 weeks)
- Change from Baseline Short Physical Performance Battery (SPPB) at 6 weeks(Baseline, 6 weeks)
- Change from Baseline Letter Fluency Test at 6 weeks(Baseline, 6 weeks)
- Change from Baseline Trail Making Test at 6 weeks(Baseline, 6 weeks)
- Change from Baseline Clock-in-the-Box Test at 6 weeks(Baseline, 6 weeks)
- Change from Baseline Hopkins Verbal Learning Test at 6 weeks(Baseline, 6 weeks)
研究者
Jonathan F. Bean
Director, New England Geriatric Research Education and Clinical Center
VA Boston Healthcare System