Healthy Cognition
Conditions
Keywords
Walking Exercise, Flexibility Exercise, Cognition, Memory, Magnetic Resonance Imaging
Brief summary
The investigators aim to compare the effects of a 6-month moderate intensity exercise training (ET) intervention to a low intensity flexibility exercise control condition (FC) on brain function, cognition, and physical function in cognitively healthy and physically inactive older adults (ages 60-80). Apolipoprotein E epsilon4 (APOE-ε4) allele carriers are known to be at substantially greater risk for cognitive decline and Alzheimer's disease (AD). Cognitively intact APOE-ε4 allele carriers, and non-carriers, will be randomly assigned to 6-months of either supervised moderate intensity aerobic exercise training (ET) or supervised flexibility exercise control (FC). The ET and FC each contain a group based exercise component and are run in local retirement communities near College Park, MD, or on the University of Maryland College Park campus. The primary aims of the study are to compare pre-intervention to post-intervention changes in episodic memory performance and MRI biomarkers.
Interventions
OTHERExercise Training
Supervised exercise conducted four days per week for six months.
OTHERFlexibility Control
Supervised exercise conducted four days per week for six months.
Sponsors
University of Maryland, College Park
National Institute on Aging (NIA)
Johns Hopkins University
Marquette University
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and outcomes assessors are masked to APOE genotype. We do not share any data with care providers.
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 60 to 80 years old * Fluent in English * Willingness to make the time commitment to participate in the project, including randomization to treatments * Physically inactive (physical activity not more than 2 days per week for the past 6 months) * Physician consent to undergo an exercise stress test and engage in moderate intensity exercise * Determined to be safe for MRI
Exclusion criteria
* Neurological illnesses/conditions such as cerebral palsy, epi¬lepsy, brain tumor, chronic meningitis, multiple scle¬rosis, pernicious anemia, normal-pressure hydrocephalus, HIV infection, Parkinson's disease, and Huntington's disease * Untreated hypertension, glaucoma, and chronic obstructive pul¬monary disease * Untreated severe major depression * Substance abuse or dependence * Current use of psychoactive medications, except selective serotonin/norepinephrine reuptake inhibitor antidepressants * Use of acetylcholinesterase inhibitors (e.g., Aricept) * Unstable or severe cardiovascular disease or asthmatic condition * History of transient ischemic attack, cerebral ischemia, or clinically diagnosed stroke * Diagnosis of mild cognitive impairment or dementia, or objective evidence of cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rey Auditory Verbal Learning Test Sum of Trials 1-5 | Baseline and 6 months | Rey Auditory Verbal Learning Test Sum of Trials 1-5. Fifteen words are presented verbally, and participant is asked to recall as many as possible after each trial. The total sum of the words correctly recalled across trials 1 to 5 is recorded. |
| Famous Name Discrimination fMRI Activation | Baseline and 6 months | Famous minus Not Famous Name Discrimination activation using event-related fMRI (correct trials only), derived from standard preprocessing and control of family-wise error rate. The primary outcome reflects the mean activation intensity from all brain regions that were shown to be activated by the task in both the Exercise Training and Flexibility Control conditions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Rate of Oxygen Consumption (VO2peak) | Baseline and 6 months | Estimated peak rate of oxygen consumption during a treadmill graded exercise test, a measure of cardiorespiratory fitness. |
| 6 Minute Walk Test | Baseline and 6 months | Distance walked in 6 minutes |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJ. Carson Smith, PhD
University of Maryland
Participant flow
Recruitment details
Advertising and recruitment resulted in 5,284 online pre-screening surveys, which led to 266 individuals who volunteered and completed the in-person informed consent visit. Among the 266 consented individuals, 117 (44%) were determined to not meet the inclusion/exclusion criteria, with the most common reason being identification of cognitive impairment, and 25 voluntarily withdrew from the study, leaving 124 who completed baseline testing. 106 of 124 completed the entire protocol.
Pre-assignment details
After informed consent, all physician consent and MRI screening forms were completed (approximately 2-6 weeks) before baseline testing was scheduled. Participants were then assigned to a treatment arm and completed the baseline testing. A total of 124 participants completed baseline, and 5 withdrew before starting the intervention. 119 started one of the two arms, and 106 of the 124 consented individuals completed the entire 6-month exercise intervention with baseline and follow-up testing.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 68.4 Years STANDARD_DEVIATION 6.2 |
| Education Bachelors Degree | 21 Participants |
| Education Doctoral Degree | 8 Participants |
| Education Graduate Degree | 27 Participants |
| Education High School | 4 Participants |
| Education Some College | 2 Participants |
| Race/Ethnicity, Customized Self-Reported Race Asian | 5 Participants |
| Race/Ethnicity, Customized Self-Reported Race Black | 7 Participants |
| Race/Ethnicity, Customized Self-Reported Race Prefer not to say | 3 Participants |
| Race/Ethnicity, Customized Self-Reported Race White | 43 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 55 |
| other Total, other adverse events | 10 / 64 | 8 / 55 |
| serious Total, serious adverse events | 3 / 64 | 1 / 55 |
Outcome results
None listed