跳至主要内容
临床试验/NCT03058146
NCT03058146终止不适用

A Novel Mobile Health Exercise Intervention in Aging: Brain Perfusion and Cognition

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2017年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
53
试验地点
2
主要终点
Moderate to Vigorous Physical Activity (MVPA) Average Per Day

研究概览

简要总结

Physical activity interventions with older adults can improve brain health; however most interventions have been performed in gym-like settings that reach a small sector of the senior population. Since not everyone can access a gym, it is important to study whether brisk walking in real world environments can also help brain health. This study will use mobile health devices to help older adults independently walk for brain health, thus representing a critical step towards the dissemination of physical activity intervention programs aimed at preserving cognitive function in aging.

详细描述

Physical activity interventions conducted in supervised settings (laboratories and group settings) with older adults have consistently shown improved cardiovascular and cerebrovascular health and improved cognitive function. What is lacking is the development of interventions that take place in real world environments and that take advantage of new technologies to help objectively track real time physical activity behaviors. Real world physical activity interventions have the potential to reach a larger segment of the population and to enhance maintenance after the intervention period ends. This study will develop a novel physical activity intervention using mobile health technologies to promote physical activity levels likely to affect cerebral blood flow and cognition in real world environments in cognitively normal older adults. A randomized controlled trial will be conducted with 30 participants being assigned to the mobile health physical activity condition (walking in free-living environments tracked via mobile health technologies) and another 30 to an education control condition (at home reading about healthy aging materials) for 3 months.

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
None

入排标准

年龄范围
65 Years 至 80 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women between the ages of 65-80
  • Ability to obtain a signed physician's clearance for participation in this study
  • English-speaking as needed to complete cognitive testing and follow study procedures
  • Cognitively normal (based on comprehensive neuropsychological assessment)
  • No contraindications for Magnetic Resonance Imaging (MRI)
  • Must be ambulatory and able to walk independently

排除标准

  • History of head injury involving loss of consciousness within the past 6 months and/or history of severe traumatic brain injury
  • Major neurological disorders (dementia, multiple sclerosis, epilepsy, etc)
  • Chronic major psychiatric disorders (schizophrenia, major recurrent affective disorder)
  • History of major vascular events (myocardial infarction, stroke, etc),
  • History of diabetes
  • History of falls in the last year resulting in hospitalization
  • Unstable or poorly controlled medical problems e.g. heart failure, diabetes (poorly controlled or on insulin), uncontrolled hypertension, pulmonary disease with hypoxia or hypercapnia, significant liver problems or renal failure, treatment of cancer in the past 2 years (other than non-melanoma skin cancer), HIV positive
  • Objective evidence of cognitive impairment based on neuropsychological assessment

结局指标

主要结局

Moderate to Vigorous Physical Activity (MVPA) Average Per Day

时间窗: Pre (baseline) and post (3 months)

Average minutes per day spent in moderate to vigorous levels of physical activity (MVPA) (defined as =\>1952 accelerometer counts per minute). MVPA minutes were determined based on one-week of accelerometer wear on the hip at baseline and post intervention.

次要结局

  • Cerebral Blood Flow (Hippocampal and Frontal)(Pre (baseline) and post (3 months))

研究者

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

Zvinka Z. Zlatar

Associate Professor

University of California, San Diego

研究点 (2)

Loading locations...

相似试验