University of Kansas Alzheimer's Disease Center
Fairway, Kansas, 66205, United States
NCT Number: NCT04848038
The number of older Americans will double in the next 4 decades to nearly 90 million, placing an unprecedented financial and resource burden on the health care system. Exercise has clear and demonstrable physical benefits, but a more precise understanding of how exercise supports cognitive function is essential. Demonstrating definitively that exercise as recommended by public health entities has benefits for cognition would have enormous public health implications, encourage the public to adapt more active lifestyles, and stimulate the development of effective exercise delivery programs.
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Notify Me65 year–80 year
All sexes
Interventional
Not applicable
Fairway, Kansas, 66205, United States
Older adults often experience physical decline that can be directly ameliorated by physical activity and exercise. Evidence is building that exercise prevents cognitive decline or delays the onset of debilitating dementia (e.g. Alzheimer's disease) yet, the optimal dose and combination of exercise modalities for promoting brain health, however, remains unknown and essentially untested.
The long-term research goal of this project is to develop and test strategies to support successful aging and prevent Alzheimer's disease. The study will enroll 280 individuals, age 65 to 80 years without cognitive impairment, into a 26-week exercise intervention to test the combined and independent effects of aerobic and resistance training on cognition, brain structure, and physical function. The project will also explore underlying biological mechanisms that may link exercise with brain health.
Participants will be randomized into 1 of 4 groups: flexibility, toning and balance (control), aerobic exercise training, progressive resistance training, or combined aerobic and resistance training. All intervention groups represent the most common modalities of exercise and directly reflect the public health recommendations for aerobic and resistance training. Exercise training will occur in a community setting through the network of Greater Kansas City Young Men's Christian Association. It is hypothesized that 26 weeks of exercise will improve 1) cognitive performance, 2) regional brain volume, 3) cardiorespiratory fitness and strength 4) biomarkers.
This will be the largest study to assess the combined and independent effects of the two most recommended forms of exercise. Demonstrating specific exercise effects on cognitive function and brain health in older adults would have enormous public health implications. The study's results will also impact public health policy and education by providing evidence towards the specific or synergistic effects of aerobic and resistance training on cognition and brain structure. Encouraging the public to adapt more active lifestyles and stimulate the development of effective exercise delivery programs to enhance initiation and maintenance of physical activity interventions is key to increasing the number of quality years of life for America's aging population.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard public health exercise recommendations
Other names: Weight Training, Aerobic Exercise, Progressive Resistance Exercise, Cross Training
Time frame: Baseline, 6 months, 12 months
Assessing change in cognitive function from baseline to 12 months. The 6 month measure is being used to assess the trajectory of the change. A comprehensive neuropsychological battery will be used that assesses a global cognition score derived from domains of cognition (e.g. Executive Function, Visuospatial Processing, Episodic Memory, Processing Speed). We will use a second order confirmatory factor analysis (CFA) to estimate the factor loadings between the observed indicators and the first order factors and between the first and second order factors. The CFA will use baseline data to avoid any potential intervention related biases. The primary outcome will be constructed by summing the weighted average (by the estimated first and second order loadings) of the standardized observed scores across the cognitive tests.
Time frame: Baseline, 12 months
Volume of bilateral hippocampus in milliliters
Time frame: Baseline, 12 months
Peak volume of oxygen used in in milliliters per kilogram of body mass per minute during a graded maximal exercise test
Time frame: Baseline, 12 months
The maximum amount of mass that can be lifted one time (summed leg press and chest press)
Time frame: Baseline
The Wechsler Test of Adult Reading is a reading recognition test that can be used to estimate intelligence quotient and memory scores
Time frame: Baseline, 6 months, 12 months
The Hopkins Verbal Learning Test - Revised is an oral test that has been validated within brain-disordered populations (e.g., Alzheimer's disease, amnestic disorders) as a measure of verbal learning and memory.
Time frame: Baseline, 6 months, 12 months
The NIH ToolboxFlanker Task is a computer based test to assess selective attention and inhibitory function.
Time frame: Baseline, 6 months, 12 months
The NIH Toolbox Dimensional Change Card Sort is a computer based test to assess cognitive flexibility and attention.
Time frame: Baseline, 6 months, 12 months
The NIH Toolbox Oral Symbol Digit Test is a computer based test to Measure of processing speed.
Time frame: Baseline, 6 months, 12 months
The Virginia Cognitive Aging Project Logical Memory test measures episodic verbal memory.
Time frame: Baseline, 26-weeks, 52-weeks
In this computer task, participants are asked to determine which three-dimensional figure can be formed from a two-dimensional pattern presented. This task measures visual construction ability.
Time frame: Baseline, 6 months, 12 months
This paper-based task measures processing speed.
Time frame: Baseline, 6 months, 12 months
This computer-based task measures visuospatial ability.
Time frame: Baseline, 6 months, 12 months
This computer task asks participants to learn two different tasks. This task measures task switching.
Time frame: Baseline, 6 months, 12 months
This computer task measures spatial memory.
Time frame: Baseline, 6 months, 12 months
This paper-based oral task measures executive control, specifically attention and inhibitory control.
Time frame: Baseline, 12 months
Estimated total body, axial, appendicular and visceral fat mass from dual x-ray absorptiometry.
Time frame: Baseline, 12 months
Estimated total body, axial, appendicular lean mass from dual x-ray absorptiometry.
Time frame: Baseline, 12 months
Estimated total body, axial, appendicular bone mass and density from dual x-ray absorptiometry.
Time frame: Baseline, 12 months
Whole brain and regional cerebral blood flow estimated using arterial spin labeling, a technique of magnetic resonance imaging
Time frame: Baseline, 12 months
Composite and sub-test scores of 6 common physical activities. Scores can be normalized for age and sex
Time frame: Baseline, 12 months
The circumference of the waist and hip areas are measured via measuring tape.
Time frame: Baseline, 12 months
Height and body mass are measured and Body Mass Index is calculated based on a standard equation.
Time frame: Baseline, 12 months
Blood lactate concentration is measured before and after a bout of exercise.
Time frame: Baseline, 6 months, 12 months
The MacArthur Scale of Subjective Social Status (MacArthur Socio-Economic Status Scale) contains questions regarding finances, assets and other home socioeconomics.
Time frame: Baseline, 6 months, 12 months
Computer-based adaptive questionnaire of self-rated cognitive function.
Time frame: Baseline, 6 months, 12 months
Computer-based adaptive questionnaire of self-rated cognitive concerns.
Time frame: Baseline, 6 months, 12 months
Computer-based adaptive questionnaire of self-rated anxiety.
Time frame: Baseline, 6 months, 12 months
Computer-based adaptive questionnaire of self-rated depression.
Time frame: Baseline, 6 months, 12 months
Computer-based adaptive questionnaire of self-rated social roles.
Time frame: Baseline, 6 months, 12 months
Computer-based adaptive questionnaire of self-rated life satisfaction.
Time frame: Baseline, 6 months, 12 months
Computer-based adaptive questionnaire of self-rated life physical function.
Time frame: Baseline, 6 months, 12 months
Paper-based questionnaire of self-rated sleep quality.
Time frame: Baseline, 6 months, 12 months
Paper-based questionnaire of self-rated appraisal of stress.
Time frame: Baseline, 6 months, 12 months
A visual analog scale of quality of life
Time frame: Baseline, 6 months, 12 months
Self-rated computer based questionnaire of dietary intake.
Time frame: Baseline, 6 months, 12 months
Self-rated computer based questionnaire of mediterranean diet eating pattern.
Time frame: Baseline, 3 months, 6 months, 12 months
Self-rated computer based questionnaire of physical activity self-efficacy.
Time frame: Baseline, 3 months, 6 months, 12 months
Self-rated computer based questionnaire of exercise goal self-efficacy.
Time frame: Baseline, 3 months, 6 months, 12 months
Self-rated computer based questionnaire of leisure-time physical activity self-efficacy.
Time frame: Baseline, 3 months, 6 months, 12 months
Self-rated computer based measure of physical activity self-regulation for use with older adults.
Time frame: Baseline, 3 months, 6 months, 12 months
Self-rated computer based measure of use of leisure-time for physical activity
Time frame: Baseline, 6 months, 12 months
Brain Derived Neurotrophic factor , Insulin Growth Factor-1 (IGF-1), lactate, glucose and insulin levels, inflammatory cytokines, plasma phosphorylated tau (various form), plasma beta-amyloid (various forms), neurofilament light, glial fibrillary acidic protein and others as become available.
University of Kansas Medical Center
Other
Differential Effects of Exercise Modality on Cognition and Brain in Older Adults
Acronym: COMET
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