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

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Mild Cognitive Impairment	Behavioral: Combined Cognitive and Physical; Behavioral: Cognitive; Behavioral: Physical; Behavioral: Active 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.

Study Design

• 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
• Actual Study Start Date: January 2015
• Actual Primary Completion Date: October 25, 2019
• Actual Study Completion Date: October 25, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. Number of participants with study-related adverse events (AE) by treatment arm. [ Time Frame: From enrollment through end of treatment at 12-weeks. ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Indiana

Indiana University

Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University

National Institute on Aging (NIA)

Investigators

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

More Information

• 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
• Last Update Posted: March 7, 2023
• Last Verified: March 2023

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:

Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders