Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
201 participants
INTERVENTIONAL
2015-01-31
2019-10-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Combined Cognitive and Physical
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).
Combined Cognitive and Physical
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.
Cognitive
This consists of 45 minutes of cognitive modules from Posit Science, 3 days a week for 12 weeks (36 sessions).
Cognitive
Cognitive modules from Posit Science are designed to improve information processing speed, learning, memory, and attention.
Physical
This consists of 45 minutes of multi-modal physical exercise, 3 days a week for 12 weeks (36 sessions).
Physical
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.
Active Control
This consists of 45 minutes of group discussion of health and successful aging, 2 days a week for 12 weeks (24 sessions).
Active Control
Control modules provide social contact for group discussion of health and successful aging.
Interventions
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Combined Cognitive and Physical
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.
Cognitive
Cognitive modules from Posit Science are designed to improve information processing speed, learning, memory, and attention.
Physical
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.
Active Control
Control modules provide social contact for group discussion of health and successful aging.
Eligibility Criteria
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Inclusion Criteria
* minimal impairment in daily function per Functional Activity Questionnaire (FAQ)
* sedentary
* English speaking
* access to telephone
Exclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Indiana University
OTHER
Responsible Party
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Frederick Unverzagt
Professor
Principal Investigators
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Frederick W Unverzagt, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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Indiana University
Indianapolis, Indiana, United States
Countries
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Other Identifiers
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