Cognitive and Aerobic Resilience for the Brain (CARB)

Indiana University

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Physical; Behavioral: Cognitive; Behavioral: Active Control; Behavioral: Combined Cognitive and Physical

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02390453

1R01AG045157-01A1 (U.S. NIH Grant/Contract)

R01AG045157

Details and patient eligibility

About

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).

Full 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.

Enrollment: 201 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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201 participants in 4 patient groups

Combined Cognitive and Physical

Experimental group

Description:

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).

Treatment:

Behavioral: Combined Cognitive and Physical

Cognitive

Active Comparator group

Description:

This consists of 45 minutes of cognitive modules from Posit Science, 3 days a week for 12 weeks (36 sessions).

Treatment:

Behavioral: Cognitive

Physical

Active Comparator group

Description:

This consists of 45 minutes of multi-modal physical exercise, 3 days a week for 12 weeks (36 sessions).

Treatment:

Behavioral: Physical

Active Control

Active Comparator group

Description:

This consists of 45 minutes of group discussion of health and successful aging, 2 days a week for 12 weeks (24 sessions).

Treatment:

Behavioral: Active Control