Fit & Active Seniors Trial (FAST)
2017年2月21日 更新者：Edward McAuley、University of Illinois at Urbana-Champaign
Influence of Fitness on Brain and Cognition II
The investigators propose to test the hypothesis that a six-month intervention of combined fitness and cognitive training in the form of dancing will have a significant positive effect on a variety of executive control and memory processes as well as brain structure and function as compared to a non-aerobic strength and balance control/comparison group.
Additionally, these two groups will be compared to walking groups in which one of the walking groups will also be provided with a daily, liquid, milk-based nutritional supplement.
研究概览
地位
完全的
条件
详细说明
Our previous trial (known as HALT, Healthy Active Lifestyle Trial) suggests that improvements in aerobic fitness have beneficial effects on cognitive function that are rather specific.
That is, improvements in aerobic fitness appear to result in improvements in executive control processes such as scheduling, planning, coordination, inhibition, and working memory - some of the very cognitive abilities most affected during aging.
Indeed, executive control processes and the prefrontal and frontal regions which support them have shown substantial and disproportionate age-related declines.
The main hypothesis that the investigators test in the present project is that such deficits may be particularly benefited by improvements in aerobic fitness combined with cognitive training in the form of dance.
Additionally, we will compare the outcomes of these interventions with an aerobic condition (walking) group and an aerobic condition (walking) group that also is provided with a daily nutritional supplement (walking + nutrition).
The investigators will examine the relationship between aerobic fitness, physical activity, cognitive status, and brain function with this six-month aerobic training intervention study.
The investigators will collect psychosocial data and functional fitness data to assess other relevant changes in psychological and physical function brought about by exercise training.
Healthy, non-active older adults (60 to 79 years of age) will be recruited from the local community.
Half One quarter of the older adults will be randomly assigned to an aerobic/cognitive combination group (dance), one quarter will be while the remaining half of the older adults will be randomly assigned to a non-aerobic control group (stretching, strengthening, and stability), one quarter will be assigned to the walking group, and one quarter will be assigned to the walking + nutrition group.
The exercise interventions will be conducted by trained exercise staff.
The participants will be assessed before and after the intervention (6 months).
Assessments will include (a) cardiorespiratory testing, (b) physical activity monitoring (c) performance on neurocognitive tests of executive and non-executive function (d) measures of brain activation (fMRI) during cognitive tasks in a 3.0 tesla MRI system (e) a battery of psychosocial questionnaires (f) functional performance measures and (g) a mock street walking task.
研究类型
介入性
注册 (实际的)
247
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Illinois
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Urbana、Illinois、美国、61801
- University of Illinois
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
60年 至 79年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 60-79 years of age
- Low-active: zero to two days of physical activity (> 30 minutes per day) per week in previous six months.
- Personal physician's examination and/or consent to participate in testing and exercise intervention
- Successful completion of graded exercise test without evidence of cardiac abnormalities or responses which are likely to be exacerbated by exercise. This decision will be made by the attending cardiologist.
- Adequate responses to the Telephone Interview of Cognitive Status (TICS-M) questionnaire
- Corrected (near and far) acuity of 20/40 or better in both eyes and no diagnosis of color-blindedness
- Initial depression score on GDS-15 (Geriatric Depression Scale) below clinical level (> 10)
- No presence of implanted devices or metallic bodies above the waist
- No history of brain surgery that involved removal of brain tissue
- Right-handed
- No history of stroke or Transient ischemic attack(TIA)
- Intention to remain in the local area for the duration of the intervention or testing period
- English fluency
Exclusion Criteria:
- Below 60 years of age or above 80 years of age at beginning of intervention
- Self-reported regular physical activity of more than 2 times per week in last six months
- Non-consent of physician
- Evidence of abnormal cardiac responses or conditions during graded exercise testing
- Inadequate responses to the Telephone Interview of Cognitive Status (TICS-M) questionnaire (<20)
- Uncorrectable (near and far) acuity of greater than 20/40 in either eye and/or color-blindness
- Depression score on GDS-15 indicative of clinical depression (≤ 10)
- Presence of any implanted devices above the waist i.e. cardiac pacemaker or auto-defibrillators; neural pacemaker; aneurysm clips in the Central Nervous System(CNS); cochlear implant; metallic bodies in the eye or CNS; any form of wires or metal devices that may concentrate radiofrequency fields
- History of brain surgery that involved removal of brain tissue
- Left-handed
- History of Stroke or TIA
- Intent to move or be away from the area for an extended period of time (i.e. > 3 weeks) during the intervention or testing period
- Inability to communicate effectively in English
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Dance
Participants will be instructed in various forms of dances such as ballroom, swing, waltz, folk, and English country.
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Participants will be instructed and learn various forms of dance (i.e.
English country, folk, ballroom) and will be led by trained dance instructors and exercise specialists.
Participants will for one-hour sessions and meet three times per week for six months.
其他名称：
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有源比较器：Strengthening, Stability, Stretching
Participants will be instructed in various forms of strength, stretching (flexibility) and stability (balance)exercises.
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Exercises focusing on strength, flexibility and balance will be performed at one-hour sessions held three times per week for six months.
Classes are led by trained exercise specialists.
其他名称：
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实验性的：Walking
Participants in this moderate aerobic conditioning exercise program will be instructed in a walking program that focuses on having them walk within their target heart rate.
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Participants in this moderate aerobic conditioning exercise program will be instructed in a walking program that focuses on having them walk within their target heart rate.
They will be provided with heart rate monitors and pedometers for accurate record keeping.
They will meet three times per week for one hour for six months.
Warm up and cool down stretches will be a part of each walking session and sessions will be monitored and led by trained exercise specialists.
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实验性的：Walking + Nutritional Supplement
Participants in this moderate aerobic conditioning exercise program will be instructed in a walking program that focuses on having them walk within their target heart rate.
These participants will also be provided with a daily nutritionally balanced liquid, milk-based formula.
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Participants in this moderate aerobic conditioning exercise program will be instructed in a walking program that focuses on having them walk within their target heart rate.
They will be provided with heart rate monitors and pedometers for accurate record keeping.
They will meet three times per week for one hour for six months.
Warm up and cool down stretches will be a part of each walking session and sessions will be monitored and led by trained exercise specialists.
Participants in this moderate aerobic conditioning exercise program will be instructed in a walking program that focuses on having them walk within their target heart rate.
They will be provided with heart rate monitors and pedometers for accurate record keeping.
They will meet three times per week for one hour for six months.
Warm up and cool down stretches will be a part of each walking session and sessions will be monitored and led by trained exercise specialists.
These participants will also be provided with a daily nutritionally balanced liquid, milk-based supplement formula.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change from baseline to month six in brain structure and function
大体时间：Baseline and six months
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Participants will undergo a neuropsychological battery of tasks assessing memory, attention and decision-making at baseline and month six.
They will also undergo an fMRI during which images of brain structure and function (completing tasks during image collection) will be compared from baseline to month six.
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Baseline and six months
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Change from baseline to month six in cardiorespiratory fitness
大体时间：Baseline and six months
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We will conduct graded maximal exercise treadmill test measuring peak oxygen consumption at baseline and six months.
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Baseline and six months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change from baseline to month six: Quality of life
大体时间：Baseline and six months
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We will assess multiple indicators of Quality of Life such as: depression; physical and mental health status; satisfaction with life; etc.
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Baseline and six months
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Change from baseline to month six: Self-efficacy
大体时间：Baseline, three weeks and six months
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We will examine the extent to which self-efficacy (e.g.
barriers, adherence, function) changes as a function of participation in regular group physical activity training.
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Baseline, three weeks and six months
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Program adherence over six month intervention
大体时间：Six months
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We will monitor attendance during the six-month intervention(program meets three days per week).
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Six months
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Change from baseline to month six: Physical function
大体时间：Baseline and six months
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We will conduct functional fitness testing including tests of balance, strength, mobility and flexibility at baseline and six months.
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Baseline and six months
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Change from baseline to month six: Psychosocial Outcomes
大体时间：Baseline and six months
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We will assess changes in psychosocial function (e.g.
self-esteem; social support; anxiety) by written questionnaires.
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Baseline and six months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Arthur F Kramer, PhD、University of Illinois at Chicago
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Mendez Colmenares A, Voss MW, Fanning J, Salerno EA, Gothe NP, Thomas ML, McAuley E, Kramer AF, Burzynska AZ. White matter plasticity in healthy older adults: The effects of aerobic exercise. Neuroimage. 2021 Oct 1;239:118305. doi: 10.1016/j.neuroimage.2021.118305. Epub 2021 Jun 24.
- Burzynska AZ, Voss MW, Fanning J, Salerno EA, Gothe NP, McAuley E, Kramer AF. Sensor-measured sedentariness and physical activity are differentially related to fluid and crystallized abilities in aging. Psychol Aging. 2020 Dec;35(8):1154-1169. doi: 10.1037/pag0000580. Epub 2020 Sep 24.
- Gothe NP, Ehlers DK, Salerno EA, Fanning J, Kramer AF, McAuley E. Physical Activity, Sleep and Quality of Life in Older Adults: Influence of Physical, Mental and Social Well-being. Behav Sleep Med. 2020 Nov-Dec;18(6):797-808. doi: 10.1080/15402002.2019.1690493. Epub 2019 Nov 12.
- Baniqued PL, Gallen CL, Voss MW, Burzynska AZ, Wong CN, Cooke GE, Duffy K, Fanning J, Ehlers DK, Salerno EA, Aguinaga S, McAuley E, Kramer AF, D'Esposito M. Brain Network Modularity Predicts Exercise-Related Executive Function Gains in Older Adults. Front Aging Neurosci. 2018 Jan 4;9:426. doi: 10.3389/fnagi.2017.00426. eCollection 2017.
- Awick EA, Ehlers DK, Aguinaga S, Daugherty AM, Kramer AF, McAuley E. Effects of a randomized exercise trial on physical activity, psychological distress and quality of life in older adults. Gen Hosp Psychiatry. 2017 Nov;49:44-50. doi: 10.1016/j.genhosppsych.2017.06.005. Epub 2017 Jun 15.
- Ehlers DK, Daugherty AM, Burzynska AZ, Fanning J, Awick EA, Chaddock-Heyman L, Kramer AF, McAuley E. Regional Brain Volumes Moderate, but Do Not Mediate, the Effects of Group-Based Exercise Training on Reductions in Loneliness in Older Adults. Front Aging Neurosci. 2017 Apr 25;9:110. doi: 10.3389/fnagi.2017.00110. eCollection 2017.
- Burzynska AZ, Jiao Y, Knecht AM, Fanning J, Awick EA, Chen T, Gothe N, Voss MW, McAuley E, Kramer AF. White Matter Integrity Declined Over 6-Months, but Dance Intervention Improved Integrity of the Fornix of Older Adults. Front Aging Neurosci. 2017 Mar 16;9:59. doi: 10.3389/fnagi.2017.00059. eCollection 2017.
- Ehlers DK, Banducci SE, Daugherty AM, Fanning J, Awick EA, Porter GC, Burzynska A, Shen S, Kramer AF, McAuley E. Effects of Gait Self-Efficacy and Lower-Extremity Physical Function on Dual-Task Performance in Older Adults. Biomed Res Int. 2017;2017:8570960. doi: 10.1155/2017/8570960. Epub 2017 Feb 1.
- Ehlers DK, Fanning J, Awick EA, Kramer AF, McAuley E. Contamination by an Active Control Condition in a Randomized Exercise Trial. PLoS One. 2016 Oct 10;11(10):e0164246. doi: 10.1371/journal.pone.0164246. eCollection 2016.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年8月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2011年8月18日
首先提交符合 QC 标准的
2011年11月11日
首次发布 (估计)
2011年11月16日
研究记录更新
最后更新发布 (实际的)
2017年2月23日
上次提交的符合 QC 标准的更新
2017年2月21日
最后验证
2017年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.