Clinical trial NCT02390453: Cognitive and Aerobic Resilience for the Brain
Official title: Cognitive and Aerobic Resilience for the Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: mild cognitive impairment
randomized controlled trial
cognitive training
exercise training
cognition
physical performance
disability
mood
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2015-03-17
Enrollment: 201
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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
* 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

Primary outcomes:
measure: Cognitive function composite score as measured by individually-administered tests of psychomotor speed, complex sequencing, and list learning.
timeFrame: End of treatment at 12-weeks.
measure: Average participant self-ratings of intervention acceptability.
timeFrame: From date of randomization until the date of the final training session or the end of the 12-week intervention, whichever came first.
measure: Participant adherence to treatment.
timeFrame: From date of randomization until the date of the final training session or the end of the 12-week intervention, whichever came first.
measure: Participant adherence to outcome assessment.
timeFrame: End of treatment at 12-weeks.
measure: Number of participants with study-related adverse events (AE) by treatment arm.
timeFrame: From enrollment through end of treatment at 12-weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Frederick W Unverzagt, PhD
role: PRINCIPAL_INVESTIGATOR
References: