Cognitive and Aerobic Resilience for the Brain

Indiana University201 enrolled

Overview

This is a randomized controlled trial (RCT) of the effectiveness of cognitive and exercise training versus control condition on cognitive function in older adults with mild cognitive impairment (MCI).

Exercise and cognitive training hold promise for delaying progression of MCI. Exercise improves cognitive ability, brain function, and brain structure in older adults. Cognitive training has been shown to durably improve mental abilities and functional status in older adults. In addition, persons with MCI respond to some forms of cognitive training just as robustly as healthy older adults. This pilot study is a 4 group design with a home-based multi-modal physical exercise intervention, cognitive training, combined cognitive and physical training, and a social contact control enrolling older adults with MCI. This pilot study is designed to be consistent with current recommended approaches to establishing trial feasibility. If the aims are achieved, it will provide a conceptual and practical rationale to support a large, multi-site, randomized clinical trial to test the efficacy of combined physical and cognitive training in delaying time to a clinical diagnosis of dementia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

201

Conditions

Mild Cognitive Impairment

Interventions

Combined Cognitive and PhysicalBEHAVIORAL

Combined modules provide Cognitive training from Posit Science designed to improve information processing speed, learning, memory, and attention, and Physical training focused on seated aerobic and progressive resistance exercises designed to improve aerobic capacity, muscular strength, and endurance consistent with current exercise recommendations for older adults.

CognitiveBEHAVIORAL

Cognitive modules from Posit Science are designed to improve information processing speed, learning, memory, and attention.

PhysicalBEHAVIORAL

Physical modules are focused on seated aerobic and progressive resistance training designed to improve aerobic capacity, muscular strength, and endurance consistent with current exercise recommendations for older adults.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * subjective memory complaint * minimal impairment in daily function per Functional Activity Questionnaire (FAQ) * sedentary * English speaking * access to telephone Exclusion Criteria: * dementia or Alzheimer disease * stroke, past 12 months * myocardial infarction, past 12 months * angina * Parkinson disease * multiple sclerosis * epilepsy * AIDS * brain tumor, infection, or surgery * brain injury with \> 30 minute LOC * schizophrenia * bipolar disorder * cancer with short life expectancy * current chemotherapy or radiation therapy * depression * alcohol consumption ≥ 8 drinks per week for women, or ≥15 drinks per week for men * prescription of Aricept or Namenda, past or present * self-reported difficulty reading a newspaper (low visual acuity) * low hearing or communicative ability (examiner-rated) that would interfere with interventions and outcome assessments * prior involvement in similar cognitive training studies, programs, or online training * prior use of online brain training or brain fitness programs * unable to pass the Exercise Assessment and Screening for You (EASY) * living in nursing home * scheduling conflicts with intervention schedule * unwilling to use a computer or be on video conferencing * Baseline blood pressure of Systolic \> 180 * Baseline blood pressure of Diastolic \> 100 * Baseline pulse of \< 40 or \> 100 * unable to provide informed consent

Locations (1)

Indiana University

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Cognitive function composite score as measured by individually-administered tests of psychomotor speed, complex sequencing, and list learning.

The cognitive composite is derived from: WAIS-IV Symbol Search, Trail Making Test Part B, and Rey Auditory Verbal Learning Test.

Time frame: End of treatment at 12-weeks.

Average participant self-ratings of intervention acceptability.

Average of individual Likert self-ratings of the interventions (where 1 = very unenjoyable, 2 = not enjoyable, 3 = neutral, 4 = enjoyable, and 5 = very enjoyable) for each session of the 12-week intervention.

Time frame: From date of randomization until the date of the final training session or the end of the 12-week intervention, whichever came first.

Participant adherence to treatment.

Number of training sessions attended divided by the the total number of sessions available.

Time frame: From date of randomization until the date of the final training session or the end of the 12-week intervention, whichever came first.

Participant adherence to outcome assessment.

Number of participants completing the post-training outcome assessment divided by the total number randomized.

Time frame: End of treatment at 12-weeks.

Number of participants with study-related adverse events (AE) by treatment arm.

Time frame: From enrollment through end of treatment at 12-weeks.

Data from ClinicalTrials.gov

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