Cognitive and Aerobic Resilience for the Brain
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- Indiana University
- Enrollment
- 201
- Locations
- 1
- Primary Endpoint
- Average participant self-ratings of intervention acceptability.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Frederick Unverzagt
Professor
Indiana University
Eligibility Criteria
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
- •Parkinson disease
- •multiple sclerosis
- •brain tumor, infection, or surgery
- •brain injury with \> 30 minute LOC
- •schizophrenia
- •bipolar disorder
- •cancer with short life expectancy
Outcomes
Primary Outcomes
Average participant self-ratings of intervention acceptability.
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.
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.
Participant adherence to treatment.
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.
Number of training sessions attended divided by the the total number of sessions available.
Participant adherence to outcome assessment.
Time Frame: End of treatment at 12-weeks.
Number of participants completing the post-training outcome assessment divided by the total number randomized.
Cognitive function composite score as measured by individually-administered tests of psychomotor speed, complex sequencing, and list learning.
Time Frame: End of treatment at 12-weeks.
The cognitive composite is derived from: WAIS-IV Symbol Search, Trail Making Test Part B, and Rey Auditory Verbal Learning Test.
Number of participants with study-related adverse events (AE) by treatment arm.
Time Frame: From enrollment through end of treatment at 12-weeks.