Active Gains in Brain Using Exercise During Aging: AGUEDA Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in executive function
研究概览
简要总结
AGUEDA (Active Gains in brain using Exercise During Aging) is a randomized controlled trial designed to examine the effects of a 24-week resistance exercise program on brain health in cognitively normal adults between 65-80 years of age.
详细描述
Exercise has emerged as the most promising non-pharmacologic intervention for improving brain health in older adults. The main aim of AGUEDA (Active Gains in brain using Exercise During Aging) trial is to examine the effects of a 6-month resistance exercise program on executive function in cognitively normal older adults. The secondary aims are (i) to examine the effects of exercise on central and peripheral brain markers, and (ii) to investigate mediators and moderators of the exercise-derived improvements observed in executive function and brain markers. AGUEDA is a randomized controlled trial in which 90 cognitively normal older adults, aged 65-80 years old, will be randomized into an exercise group (n=45) or a wait-list control group (n=45). Participants assigned to the exercise group will participate in a 24-week resistance exercise program (3 sessions/week, 60 min/session), while the control group will be asked to maintain their usual lifestyle. A comprehensive neuropsychological test battery, amyloid PET scan, cutting-edge MRI scan, DXA scan, physical fitness, physical function and physical activity measures will be used. Blood, saliva and fecal samples will be collected. Mental health and psychosocial variables will be self-reported.
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
- Double (Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Men and women 65 - 80 years.
- •Able to speak and read fluent Spanish.
- •Living in community during the study.
- •Reliable means of transportation.
- •Being physical inactive (i.e., not to be participating in the last 6 months in any resistance exercise program, or accumulating less than 600 METS/Week of moderate-vigorous physical activity).
- •Classified as cognitively normal according to Stics-m MMSE and MOCA tests.
排除标准
- •Ambulatory with pain or regular use of an assisted walking device.
- •Medical contraindication for inclusion in an exercise program.
- •Neurological condition (Multiple Sclerosis, Parkinson Disease, Dementia) or brain injury (traumatic or stroke).
- •Current diagnosis and treatment of a DSM-V Axis I or II disorder including major depression and seeing a psychologist, therapist, or psychiatrist.
- •History of major psychiatric illness including schizophrenia, general anxiety disorder or depression (GDS-30>=15).
- •Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, deep venous thrombosis or other cardiovascular event.
- •Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year.
- •Current or previous treatment for any type of cancer.
- •Type I Diabetes or uncontrolled Type II Diabetes defined as Insulin dependent or Hba1C greater than
- •Recent treatment for alcohol or substance abuse.
- •Presence of metal implants (e.g., pacemaker, stents, joint replacement) that would be MRI ineligible.
- •Claustrophobia.
- •Color blindness.
- •Diagnosis of COVID-19 with hospitalization in intensive care unit.
- •Any other consideration that interferes with the study aims and could be a risk to the participant, at the discretion of the researcher.
结局指标
主要结局
Change in executive function
时间窗: Baseline, 3 months and 6 months
The main outcome is change in executive function from baseline to 6 months. The 3-month measure is used to assess the trajectory of the change. A comprehensive neuropsychological battery will assess several domains of executive function: working memory, cognitive flexibility and inhibitory control.
次要结局
- Change in memory performance(Baseline and 6 months)
- Change in fluid and crystallized intelligence(Baseline and 6 months)
- Change in hippocampal brain morphology(Baseline and 6 months)
- Change in other peripheral neurology biomarkers(Baseline and 6 months)
- Change in general cognition(Baseline and 6 months)
- Change in brain amyloid beta(Baseline and 6 months)
- Change in other cognitive outcomes(Baseline and 6 months)
- Change in brain morphology(Baseline and 6 months)
- Change in white matter structure(Baseline and 6 months)
- Change in cerebral blood flow(Baseline and 6 months)
- Change in brain function(Baseline and 6 months)
- Change in peripheral amyloid beta(Baseline and 6 months)
研究者
Irene Esteban-Cornejo
Principal Investigator
Universidad de Granada