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Cognitive and Aerobic Resilience for the Brain

Not Applicable
Completed
Conditions
Mild Cognitive Impairment
Interventions
Behavioral: Combined Cognitive and Physical
Behavioral: Active Control
Behavioral: Cognitive
Behavioral: Physical
Registration Number
NCT02390453
Lead Sponsor
Indiana University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
201
Inclusion Criteria
  • subjective memory complaint
  • minimal impairment in daily function per Functional Activity Questionnaire (FAQ)
  • sedentary
  • English speaking
  • access to telephone
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Combined Cognitive and PhysicalCombined Cognitive and PhysicalThis consists of 45 minutes of Cognitive arm + 45 minutes of Physical arm (90 minutes total), 3 days a week for 12 weeks (36 sessions).
Active ControlActive ControlThis consists of 45 minutes of group discussion of health and successful aging, 2 days a week for 12 weeks (24 sessions).
CognitiveCognitiveThis consists of 45 minutes of cognitive modules from Posit Science, 3 days a week for 12 weeks (36 sessions).
PhysicalPhysicalThis consists of 45 minutes of multi-modal physical exercise, 3 days a week for 12 weeks (36 sessions).
Primary Outcome Measures
NameTimeMethod
Average participant self-ratings of intervention acceptability.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.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.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.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.From enrollment through end of treatment at 12-weeks.
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Indiana University

🇺🇸

Indianapolis, Indiana, United States

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