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临床试验/NCT02136368
NCT02136368已完成不适用

A Combined Exercise Program Plus Cognitive Training for Older Adults With Self-reported Cognitive Complaints: The Multi-modal, Mind-motor (M4) Study

Lawson Health Research Institute2 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
127
试验地点
2
主要终点
Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks

研究概览

简要总结

The purpose of this study is to investigate whether an exercise class with a cognitive (or brain) training component was more effective than a usual combined aerobic and resistance exercise class for older adults with cognitive complaints (such as concerns about changes in memory or thinking skills). It is hypothesized that the group randomized to the exercise class that includes additional brain training will have greater improvements in brain health.

详细描述

Older adults with self-reported cognitive complaints (CCs) may be at increased risk for the development of Alzheimer's disease and dementia. Cognitive decline in older adults, particularly reduced memory and executive function is associated with functional decline, institutionalization, and increased health care costs. Similarly, cardiovascular risk factors have been associated with cognitive and functional impairment in aging. Aerobic exercise has been shown to improve vascular function and blood flow in the brain's prefrontal cortex. In turn, resistance training can produce functional changes within distinct cortical regions during the encoding and recall of association tasks and has been shown to increase circulating neural growth factors (i.e., a proposed mechanism by which cognition may be preserved or improved in old age). Recent evidence also suggests that cognitive training may improve the cognitive performance of older adults.

Therefore, we will investigate the impact of a combined exercise program (multi-modality exercise; M2) compared to a combined exercise program with a cognitive component (multi-modality, mind-motor exercise; M4) on cognition, cognitive-motor, mobility, neural functioning and vascular outcomes in older adults with cognitive complaints. Community-based exercise programs for older adults provide widespread access, are relatively inexpensive, and provide opportunities for social interaction.

The primary purpose of this study is to compare the effects of the M2 and M4 exercise programs on brain health. This study will also examine the effects of the different exercise programs on cardiovascular risk factors and mobility. In a subset of participants, cognitive-motor and neural functioning outcomes will be examined.

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
Single (Outcomes Assessor)

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 55 years or older
  • self-reported cognitive complaint (defined as answering yes to the question "Do you feel like your memory or thinking skills have gotten worse recently?).
  • independent on instrumental activities of daily living

排除标准

  • Probable Dementia (i.e., diagnosis OR Mini-Mental State Examination score <24)
  • Other neurological conditions or major psychiatric disorders (i.e., Parkinson's disease; bipolar disorder)
  • Previous history of severe cardiovascular conditions (i.e., myocardial infarction or stroke <1-year ago; end stage congestive heart failure; end stage renal disease)
  • Severe sensory impairment (i.e., blind)
  • Significant orthopedic conditions (i.e., severe osteoarthritis)
  • Clinical depression (determined via >=16 on the Center for Epidemiologic Studies - Depression Scale AND review by primary study physician)
  • Have blood pressure >180/100 mmHg or <100/60 mmHg
  • Unable to comprehend questionnaire material
  • Any other factors that could potentially limit ability to fully participate in the intervention

结局指标

主要结局

Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks

时间窗: 6 months

To assess global cognitive function

次要结局

  • Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks(12 months)
  • Gait variability (stride time) under dual-task conditions(6 & 12 months)
  • Gait velocity (speed) under dual-task conditions(6 & 12 months)
  • Gait velocity (speed) under single-task conditions(6 & 12 months)
  • Step length (average) under dual-task conditions(6 & 12 months)
  • Composite score of executive function tasks from Cambridge Brain Sciences Cognitive Battery(6 & 12 months)
  • Gait variability (stride time) under single-task conditions(6 & 12 months)
  • Clinic Diastolic Blood Pressure(6 & 12 months)
  • Step length (average) under single-task conditions(6 & 12 months)
  • Carotid Artery Compliance(6 & 12 months)
  • Carotid Artery Intima-media thickness(6 & 12 months)
  • Ambulatory Systolic Blood Pressure(6 & 12 months)
  • Composite score of concentration tasks from Cambridge Brain Sciences Cognitive Battery(6 & 12 months)
  • Clinic Systolic Blood Pressure(6 & 12 months)
  • Ambulatory Diastolic Blood Pressure(6 & 12 months)
  • Total balance score(6 & 12 months)
  • Composite score of memory tasks from Cambridge Brain Sciences Cognitive Battery(6 & 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rob Petrella

Principal Investigator

Lawson Health Research Institute

研究点 (2)

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