跳至主要内容
临床试验/NCT06107842
NCT06107842招募中不适用

Relationship of Exercise Frequency, Intensity, and Fitness to Improved Cognition and Biomarkers in Gerofit Participants

VA Office of Research and Development4 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年4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
招募中
入组人数
150
试验地点
4
主要终点
Executive Function composite score

研究概览

简要总结

Over 50% of the Veterans enrolled for VA health care are over the age of 65. Dementia prevalence increases with age, and with the increase in the population of people ages 65 and older, the total number of people with dementia is also increasing. Older Veterans often have comorbid PTSD, major depression and traumatic brain injury so that they are at 2 to 5 times the risk for cognitive impairment and dementia compared to the general population. There is evidence that exercise interventions in sedentary older adults could improve both physical and cognitive function. However, there have been very few studies on the effects of exercise on cognition in older Veterans and do not reflect the broader ethnic and health-status diversity of Veterans. Thus, improved knowledge of the role of exercise on cognition as well as the predictive power of biomarkers could have a major beneficial impact on Veterans' functional independence and quality of life. The investigators hypothesize that participation in the VA Gerofit exercise program will improve cognitive function in older Veterans and that blood and muscle biomarkers will predict these improvements.

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)

盲法说明

Gerofit intervention vs Health Education Control

入排标准

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

入选标准

  • All Veterans eligible for VA Gerofit program 65 years and older
  • Clearance by PCP to participate in Gerofit exercise program

排除标准

  • Inability to perform ADLs
  • Significant cognitive impairment
  • Inability to function independently without assistance
  • Unstable angina; proliferative diabetic retinopathy
  • Oxygen dependent
  • Unwillingly to commute and/or not able to provide own transportation to Gerofit
  • Incontinence
  • Open wounds
  • Volatile behavioral issue or unable to work successfully in a group environment/setting
  • Active substance abuse
  • Homelessness

研究组 & 干预措施

Gerofit exercise

Active Comparator

Participants enrolled in the Gerofit program

干预措施: Gerofit exercise (Behavioral)

Health education

Placebo Comparator

Participants enrolled in monthly in-person health education sessions which do not include a physical activity/exercise promotion session

干预措施: Health education (Behavioral)

结局指标

主要结局

Executive Function composite score

时间窗: Change from baseline at 12 months

Stroop C, Trails B, Digit span backwards and sequencing from WAIS-IV, verbal fluency, FAS and animals

Total BDNF

时间窗: Change from baseline at 12 months

Total brain derived neurotrophic factor (BDNF) concentrations in serum

Mature BDNF

时间窗: Change from baseline at 12 months

Mature brain derived neurotrophic factor (BDNF) concentrations in serum

Memory composite score

时间窗: Change from baseline at 12 months

HVLT-R, verbal memory and BVMT-R, visual memory

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (4)

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