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Cognitive and Aerobic Resilience for the Brain (CARB)

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ClinicalTrials.gov Identifier: NCT02390453
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : June 25, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Frederick Unverzagt, Indiana University

Tracking Information
First Submitted Date  ICMJE March 5, 2015
First Posted Date  ICMJE March 17, 2015
Last Update Posted Date June 25, 2021
Study Start Date  ICMJE January 2015
Actual Primary Completion Date October 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2021)
Executive Cognitive Function Composite Score as Measured by Individually-Administered Tests of Psychomotor Speed, Complex Sequencing, and List Learning [ Time Frame: Immediately following the 12-week intervention (Immediate Post-Training) ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 10, 2015)
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) ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive and Aerobic Resilience for the Brain
Official Title  ICMJE Cognitive and Aerobic Resilience for the Brain
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Mild Cognitive Impairment
Intervention  ICMJE
  • 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.
  • Behavioral: Cognitive
    Cognitive modules from Posit Science are designed to improve information processing speed, learning, memory, and attention.
  • 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.
  • Behavioral: Control
    Control modules provide social contact for group discussion and instruction in health self-management and successful aging.
Study Arms  ICMJE
  • 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).
    Intervention: Behavioral: Combined Cognitive and Physical
  • Active Comparator: Cognitive
    This consists of 45 minutes of cognitive modules from Posit Science, 3 days a week for 12 weeks (36 sessions).
    Intervention: Behavioral: Cognitive
  • Active Comparator: Physical
    This consists of 45 minutes of multi-modal physical exercise, 3 days a week for 12 weeks (36 sessions).
    Intervention: Behavioral: Physical
  • 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).
    Intervention: Behavioral: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2020)
201
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2015)
160
Actual Study Completion Date  ICMJE October 25, 2019
Actual Primary Completion Date October 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02390453
Other Study ID Numbers  ICMJE R01AG045157( U.S. NIH Grant/Contract )
1R01AG045157-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Frederick Unverzagt, Indiana University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Indiana University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Frederick W Unverzagt, PhD Indiana University
PRS Account Indiana University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP