Cognitive and Aerobic Resilience for the Brain

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Cognitive and Aerobic Resilience for the Brain

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Combined Cognitive and Physical
* Behavioral: Cognitive
* Behavioral: Physical
* Behavioral: Active Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined Cognitive and Physical<br>This consists of 45 minutes of Cognitive arm + 45 minutes of Physical arm (90 minutes total), 3 days a week for 12 weeks (36 sessions). | Behavioral: Combined Cognitive and Physical<br>* 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.<br>|
| Active Comparator: Cognitive<br>This consists of 45 minutes of cognitive modules from Posit Science, 3 days a week for 12 weeks (36 sessions). | Behavioral: Cognitive<br>* Cognitive modules from Posit Science are designed to improve information processing speed, learning, memory, and attention.<br>|
| Active Comparator: Physical<br>This consists of 45 minutes of multi-modal physical exercise, 3 days a week for 12 weeks (36 sessions). | Behavioral: Physical<br>* 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.<br>|
| Active Comparator: Active Control<br>This consists of 45 minutes of group discussion of health and successful aging, 2 days a week for 12 weeks (24 sessions). | Behavioral: Active Control<br>* Control modules provide social contact for group discussion of health and successful aging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | End of treatment at 12-weeks. | 
| Number of participants with study-related adverse events (AE) by treatment arm. |  | From enrollment through end of treatment at 12-weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild cognitive impairment, randomized controlled trial, cognitive training, exercise training, cognition, physical performance, disability, mood