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临床试验/NCT01183819
NCT01183819终止不适用

Cognitive Control and Physical Exercise: A Multi-Modal Intervention

Columbia University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2010年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
12
试验地点
1
主要终点
Changes in measures of executive control function and episodic memory at 6 months

研究概览

简要总结

The purpose of this study is to test the hypothesis that aerobic exercise and a computer-based cognitive intervention leads to improved cognitive function accompanied by increases in gray matter density and changes in functional magnetic resonance imaging (fMRI) patterns of task-related activation.

详细描述

Epidemiological evidence suggest that a set of lifetime exposures including educational and occupational attainment and leisure activities later in life are associated with more preserved cognitive and day-to-day functioning and reduced risk of dementia. However, the specific set of activities that can maintain or improve function in late life are relatively unexplored. In the current study, we will test the combined efficacy of two such activities: cognitive training and aerobic exercise. These activities have been shown to increase cognitive function and brain plasticity, respectively. The cognitive intervention that we will use is training with the Space Fortress task. This task is aimed at improving cognitive control processes that underlie multiple activities and are particularly affected by aging. We hypothesize that combining these two interventions will produce synergistic effects that will significantly improve cognitive and day-to-day function in healthy older adults.

A total of 90 cognitively-healthy older adults will be recruited and randomly assigned to one of three conditions: control video game, control exercise and combined exercise and space fortress training. A range of cognitive and day-to-day functioning will be assessed at baseline and after three months of training. We will also assess compliance with a home-based version of the training program from the end of the 3-month laboratory-based training and the effect of this compliance on measures of cognition and day-to-day functioning. We hypothesize that the interventions can be sustained over a 1-year period and that larger benefits will be observed in participants that adhere to the protocol.

We also propose two complementary approaches to investigating the neural correlates of the beneficial effects of aerobic exercise on cognition: 1) imaging -- we will use a combination of structural, metabolic, and cognitive activation fMRI studies to evaluate the neural substrates of the effect of aerobic exercise on cognition. 2) important correlates -- we will explore the effects of apolipoprotein E (APOE) genotype, inflammatory markers and cognitive reserve on the cognitive effects of aerobic exercise.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •English-speaking
  • •Strongly right-handed
  • •BMI > 18.5 and < 32
  • •Post-menopausal (women only): no estrogen replacement therapy
  • •Sedentary: VO2max < 36 ml/kg/min for men age 60-75; < 29 ml/kg/min for women age 60-75 (determined using Jones Formula Men = (60-(0.55*AGE)) Women = (48-(.37*AGE))

排除标准

  • •MRI contraindications (e.g., metallic implants, pacemaker, weight > 350 lbs, waist > 55")
  • •Hearing impaired/hearing aids, unable to read newspaper at arm's length with corrective lenses
  • •Objective cognitive impairment
  • •Ischemic changes, abnormal blood pressure responses, or any significant ectopy during aerobic capacity testing
  • •Cardiovascular disease
  • •Uncontrolled high blood pressure (systolic blood pressure ≥ 180 mmHg; or diastolic blood pressure ≥ 105 mmHg on two measures)
  • •Current or recent (evidence of disease x 5 years) non-skin neoplastic disease or melanoma
  • •Active hepatic disease (not a history of hepatitis) or primary renal disease requiring dialysis, primary untreated endocrine diseases, e.g., Cushing's disease or primary hypothalamic failure or insulin dependent diabetes (Type I or II).
  • •HIV infection
  • •Pregnant or lactating (participation allowed 3 months after ceasing lactation
  • •Other medical disorders judge to interfere with study
  • •Medications that target CNS (e.g., neuroleptics, anticonvulsants, antidepressants, benzodiazepines) within the last month
  • •Women: any selective estrogen receptor modulator or aromatase inhibitor Men: androgen ablation/deprivation hormonal therapies
  • •Any history of psychosis or electroconvulsive therapy
  • •Psychotic disorder (lifetime)
  • •Current or recent (within past 12 months) alcohol or substance abuse or dependence. Recent use (past month) of recreational drugs.
  • •Brain disorder such as stroke, tumor, infection, epilepsy, multiple sclerosis, degenerative diseases, head injury, mental retardation
  • •Imaged cortical stroke or large subcortical lacunae or infarct or space-occupying lesion (≥ 2 cubic cm). Other findings, e.g., periventricular caps or small white matter hyperintensities, do not result in exclusion
  • •Diagnosed learning disability, dyslexia

研究组 & 干预措施

Space Fortress and Exercise

Experimental

Participants engage in aerobic exercise 4 times week and Space Fortress sessions 3 times a week for a total of 12 weeks.

干预措施: Space Fortress (Behavioral)

Space Fortress and Exercise

Experimental

Participants engage in aerobic exercise 4 times week and Space Fortress sessions 3 times a week for a total of 12 weeks.

干预措施: Aerobic Exercise (Behavioral)

Control Games and Exercise

Active Comparator

Participants engage in aerobic exercise 4 times a week and control game sessions 3 times a week for a total of 12 weeks.

干预措施: Aerobic Exercise (Behavioral)

Control Games and Exercise

Active Comparator

Participants engage in aerobic exercise 4 times a week and control game sessions 3 times a week for a total of 12 weeks.

干预措施: Control Games (Behavioral)

Control Games and Stretching

Active Comparator

Participants engage in stretching/toning exercises 4 times a week and control game sessions 3 times a week for a total of 12 weeks.

干预措施: Stretching (Behavioral)

Control Games and Stretching

Active Comparator

Participants engage in stretching/toning exercises 4 times a week and control game sessions 3 times a week for a total of 12 weeks.

干预措施: Control Games (Behavioral)

结局指标

主要结局

Changes in measures of executive control function and episodic memory at 6 months

时间窗: Baseline and 12 weeks

tests of global intelligence, executive function, working memory and processing speed

次要结局

  • Changes in measures of executive control function and episodic memory at 1 year(Baseline and 52 weeks)
  • Changes in brain structure, resting cerebral blood flow and network efficiency at 6 months(Baseline and 12 weeks)
  • Change in aerobic capacity at 6 months(Baseline and 12 weeks)

研究者

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

Yaakov Stern

Professor of Clinical

Columbia University

研究点 (1)

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