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Cognitive and Aerobic Resilience for the Brain (CARB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02390453
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : March 11, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Frederick Unverzagt, Indiana University

Brief Summary:
This is a randomized controlled trial (RCT) of the effectiveness of cognitive and exercise training versus control condition on executive cognitive function in older adults with mild cognitive impairment (MCI).

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Combined Cognitive and Physical Behavioral: Cognitive Behavioral: Physical Behavioral: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cognitive and Aerobic Resilience for the Brain
Study Start Date : January 2015
Actual Primary Completion Date : October 25, 2019
Actual Study Completion Date : October 25, 2019

Arm Intervention/treatment
Experimental: 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).
Behavioral: 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.

Active Comparator: Cognitive
This consists of 45 minutes of cognitive modules from Posit Science, 3 days a week for 12 weeks (36 sessions).
Behavioral: Cognitive
Cognitive modules from Posit Science are designed to improve information processing speed, learning, memory, and attention.

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

Sham Comparator: Control
This consists of 45 minutes of group discussion and instruction in health self-management and successful aging, 2 days a week for 12 weeks (24 sessions).
Behavioral: Control
Control modules provide social contact for group discussion and instruction in health self-management and successful aging.




Primary Outcome Measures :
  1. Executive Cognitive Function Composite Score as Measured by Individually-Administered Tests of Verbal Fluency, Complex Sequencing, Response Inhibition, and List Learning [ Time Frame: Immediately following the 12-week intervention (Immediate Post-Training) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390453


Locations
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United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Frederick W Unverzagt, PhD Indiana University
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Responsible Party: Frederick Unverzagt, Professor, Indiana University
ClinicalTrials.gov Identifier: NCT02390453    
Other Study ID Numbers: R01AG045157 ( U.S. NIH Grant/Contract )
1R01AG045157-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Keywords provided by Frederick Unverzagt, Indiana University:
mild cognitive impairment
randomized controlled trial
cognitive training
exercise training
cognition
physical performance
disability
mood
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders