NCT02343029已完成不适用
Physical Activity and Cerebral Metabolism in the Elderly: a Randomised Controlled Trial
Professor Johannes Pantel4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in cerebral metabolism (assessed by MRSI)
研究概览
简要总结
Physical activity exerts a variety of long-term health benefits in older adults.This randomised controlled trial investigates the effect of a 12-week physical exercise program on the change in cerebral metabolism as assessed with Magnetic Resonance Spectroscopic Imaging. Follow-up lasts for 6 months.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •be above 65 years of age,
- •voluntariness
- •capacity to consent,
- •having passed medical entry exam by the Department of Sports Medicine,
- •regular mental capacity, 5) written informed consent
排除标准
- •untreated clotting disorders,
- •musculoskeletal diseases significantly reducing mobility,
- •severe bacterial or viral infections,
- •severe respiratory diseases (Gold IV),
- •acute pulmonary embolism,
- •instable angina pectoris or severe heart failure (NYHA III or IV),
- •severe vascular disease of the extremities or the brain,
- •severe pulmonary-cardiac dysfunction,
- •acute myocardial infarction or early phase of rehabilitation,
- •critical aortal stenosis,
- •severe hypertrophic and obstructive cardiomyopathy,
- •untreated malignant arrhythmias,
- •untreated severe hypertonia,
- •severe pulmonary hypertonia,
- •symptomatic cardiac malformations,
- •cardiac-block grade II or III,
- •left bundle branch block,
- •complex ventricular arrhythmias,
- •Cognitive impairment
结局指标
主要结局
Change in cerebral metabolism (assessed by MRSI)
时间窗: 6 month
assessed by MRSI, Primary hypothesis is that aerobic exercise leads to an increase of cerebral N-acetyl-aspartate (NAA; mediated by plasma neurotrophins). Secondary hypothesis stipulates an increase of markers of neuronal energy reserve: i.e. the ratio of phosphocreatinin to creatinine and of adenosine-tri-phosphate (ATP) to \~di-phosphate (ADP). Third hypothesis is an increase in the volume of cortical grey matter
次要结局
- Cardiopulmonary exercise test (Aerobic exercise capacity is determined by a physician-supervised CPET)(0, 3 and 6 month)
- Psychometric testing 5 (speed of cognitive processing is assessed by means of the Trail-Making-Test Part A)(0, 3 and 6 month)
- Psychometric testing 1 (verbal declarative memory [Verbal Learning and Memory test; adapted German version of the Rey Auditory Verbal Learning test](0, 3 and 6 month)
- Psychometric testing 2 (frontal executive control [Colour-Word-Interference test; adapted German version of the Stroop test; Trail-Making-Test Part B](0, 3 and 6 month)
- Psychometric testing 8 (cristalline intelligence is assessed by means of a verbal intelligence test [Multiple-Choice Word Test: MWT-B](0, 3 and 6 month)
- Psychometric testing 3 (working memory [Digit Span Test forward and backward](0, 3 and 6 month)
- Balance and strength (postural sway (balance) and gait data acquisition via the capacitive force-measuring platform (30 Hz) WinFDM v0.0.41® (Zebris© GmbH, Isny, Germany)(0, 3 and 6 month)
- Pain Assessment (German Pain Questionnaire)(0, 3 and 6 month)
- History of diet (Food frequency questionnaire DEGS1)(0, 3 and 6 month)
- History and fear of falling (German version of the Falls-Efficacy-Scale International Version)(0, 3 and 6 month)
- Psychometric testing 4 9semantic and phonematic fluency, nonverbal declarative memory and visual-constructive abilities by means of the CERAD-Plus (Consortium to Establish a Registry for Alzheimer's Disease) Neuropsychological Battery)(0, 3 and 6 month)
- Psychometric testing 6 (depressive disorders: Geriatric Depression Scale)(0, 3 and 6 month)
- Psychometric testing 7 (Age-associated subjective memory impairment is assessed using a memory complaint questionnaire [MAC-Q](0, 3 and 6 month)
- Psychometric testing 9 (dementia and mild cognitive impairment using the Mini Mental State Examination and the Instrumental Activities of Daily Living Questionnaire)(0, 3 and 6 month)
- Physical activity (International Physical Activity Questionnaire, Lifetime Total Physical Activity Questionnaire and Accelerometry)(0, 3 and 6 month)
研究者
Professor Johannes Pantel
Head of Department, Institute of General Practice
Goethe University
研究点 (4)
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