Cognitive Intervention to Improve Simple and Complex Walking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 383
- 试验地点
- 2
- 主要终点
- Change in Walking Speed During Single and Dual-task Conditions.
研究概览
简要总结
The investigators propose to conduct a single-blind randomized clinical trial to test the efficacy of a computerized cognitive remediation intervention program on improving locomotion in sedentary seniors, a group at an especially high risk for disability. The hypothesis is that executive functions will respond to the cognitive remediation program and in turn enhance locomotion.
详细描述
Emerging evidence indicates that Executive Functions play an important role in maintaining locomotion in aging and preventing mobility disabilities. However, use of cognitive training programs to improve executive functions as a strategy to increase mobility has not been explored. Exciting results from the preliminary study support the efficacy and feasibility of the cognitive remediation approach to improve locomotion in older adults.
The premise of this clinical trial is that disability among seniors is a potentially preventable chronic condition rather than an irreversible consequence of aging and disease. The investigators proposed novel approach to locomotion has the potential to shift treatment paradigms in the field of disability by introducing cognitive approaches to mobility that can be applied to prevention and rehabilitation in diverse settings. Through this 'proof of concept' secondary prevention trial the investigators will fill an important gap in knowledge for practicing evidence-based medicine and developing effective interventions for a major health outcome affecting a substantial proportion of the U.S. aging population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 70 and older, residing in the community.
- •Plan to be in area for next year.
- •Able to speak English at a level sufficient to undergo our cognitive assessment battery.
- •Ambulatory. Subjects are classified as 'non-ambulatory' if they are unable to leave the confines of their home and attend a clinic visit.
- •Gait velocity ≤1 m/s.
- •Short Physical Performance Battery score ≤9.
排除标准
- •Presence of dementia identified by any one of the following: Telephone based Memory Impairment Screen score (T-MIS) of <5, Alzheimer's Disease 8 (AD8) ≥
- •Or dementia diagnosed by baseline cognitive assessment.
- •Serious chronic or acute illness such as cancer (late stage, metastatic, or on active treatment), chronic pulmonary disease on ventilator or continuous oxygen therapy or active liver disease.
- •Mobility limitations solely due to musculoskeletal limitation or pain (e.g., severe osteoarthritis) that prevent subjects from completing mobility tests. Presence of arthritis will not be used to exclude subjects if they can complete the mobility tasks.
- •Any medical condition or chronic medication use (e.g., neuroleptics) that will compromise safety or affect cognitive functioning or terminal illness with life expectancy less than 12 months.
- •Presence of progressive, degenerative neurologic disease (e.g., Parkinson's disease or ALS).
- •Hospitalized in the past 6 months for severe illness or surgery that specifically affects mobility (e.g. hip or knee replacement) and that prevent subjects from completing mobility tests or plans for surgery affecting mobility in the next 6 months.
- •Severe auditory or visual loss.
- •Active psychoses or psychiatric symptoms (such as agitation) noted during the clinic visit that will prevent completion of study protocols.
- •Living in nursing home.
- •Participation in other intervention trial or observational studies. -
研究组 & 干预措施
Cognitive Remediation
An individualized computerized cognitive remediation program.
干预措施: Cognitive Remediation (Other)
Active control
Individualized computer based exposure and interactive health education classes.
干预措施: Active Control (Other)
结局指标
主要结局
Change in Walking Speed During Single and Dual-task Conditions.
时间窗: Baseline and 2 months
Between group difference in change per arm of gait speed (centimeters/second) measured during normal pace walking and walking while talking conditions using an instrumented walkway (GAITRite® electronic walkway system).
次要结局
- Durability(Baseline and 6 months)
- Change in Short Physical Performance Battery (SPPB).(Baseline and 2 months)
- Stride Length.(Baseline and 2 months)
- Variability in Gait Domains(Baseline and 2 Months)
- Controlled Oral Word Association Test.(Baseline and 2 Months)
- Stair Climbing Time.(Baseline and 2 Months)
- Flanker Task.(Baseline and 2 Months)
- Trail Making Test Form B.(Baseline and 2 Months)
- Gait Variability.(Baseline and 2 months)
- Digit Symbol Substitution Test.(Baseline and 2 Months)
- Trail Making Test Form A.(Baseline and 2 Months)
- Number of Participants With Substantial Gait Speed Change.(Baseline and 2 Months)
- Repeatable Battery for the Assessment of Neuropsychological Status.(Baseline and 2 Months)
- Neuroplasticity.(Baseline and 2 Months)
- Disability Scale.(Baseline and 2 Months)