Cognitive and Aerobic Resilience for the Brain (CARB)

• ClinicalTrials.gov Identifier: NCT02390453
• Recruitment Status: Completed
• First Posted: March 17, 2015
• Last Update Posted: March 7, 2023
• Sponsor: Indiana University
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Frederick Unverzagt, Indiana University

Tracking Information

• First Submitted Date: March 5, 2015
• First Posted Date: March 17, 2015
• Last Update Posted Date: March 7, 2023
• Actual Study Start Date: January 2015
• Actual Primary Completion Date: October 25, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 6, 2023)

• Cognitive function composite score as measured by individually-administered tests of psychomotor speed, complex sequencing, and list learning. [ Time Frame: End of treatment at 12-weeks. ]
  The cognitive composite is derived from: WAIS-IV Symbol Search, Trail Making Test Part B, and Rey Auditory Verbal Learning Test.
• Average participant self-ratings of intervention acceptability. [ Time Frame: From date of randomization until the date of the final training session or the end of the 12-week intervention, whichever came first. ]
  Average of individual Likert self-ratings of the interventions (where 1 = very unenjoyable, 2 = not enjoyable, 3 = neutral, 4 = enjoyable, and 5 = very enjoyable) for each session of the 12-week intervention.
• Participant adherence to treatment. [ Time Frame: From date of randomization until the date of the final training session or the end of the 12-week intervention, whichever came first. ]
  Number of training sessions attended divided by the the total number of sessions available.
• Participant adherence to outcome assessment. [ Time Frame: End of treatment at 12-weeks. ]
  Number of participants completing the post-training outcome assessment divided by the total number randomized.
• Number of participants with study-related adverse events (AE) by treatment arm. [ Time Frame: From enrollment through end of treatment at 12-weeks. ]

• Original Primary Outcome Measures (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) ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cognitive and Aerobic Resilience for the Brain
• Official Title: 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 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Mild Cognitive Impairment

Intervention

• 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: Active Control
  Control modules provide social contact for group discussion of health and successful aging.

Study Arms

• 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
• Active Comparator: Active Control
  This consists of 45 minutes of group discussion of health and successful aging, 2 days a week for 12 weeks (24 sessions).
  Intervention: Behavioral: Active Control

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 10, 2020): 201
• Original Estimated Enrollment (submitted: March 10, 2015): 160
• Actual Study Completion Date: October 25, 2019
• Actual Primary Completion Date: October 25, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02390453
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Frederick Unverzagt, Indiana University
• Original Responsible Party: Same as current
• Current Study Sponsor: Indiana University
• Original Study Sponsor: Same as current
• Collaborators: National Institute on Aging (NIA)

Investigators

• Principal Investigator: Frederick W Unverzagt, PhD; Indiana University

• PRS Account: Indiana University
• Verification Date: March 2023