Cognitive and Aerobic Resilience for the Brain (CARB)

March 6, 2023 updated by: Frederick Unverzagt, Indiana University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

201

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
End of treatment at 12-weeks.
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.
From date of randomization until the date of the final training session or the end of the 12-week intervention, whichever came first.
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.
From date of randomization until the date of the final training session or the end of the 12-week intervention, whichever came first.
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.
End of treatment at 12-weeks.
Number of participants with study-related adverse events (AE) by treatment arm.
Time Frame: From enrollment through end of treatment at 12-weeks.
From enrollment through end of treatment at 12-weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

National Institute on Aging (NIA)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

October 25, 2019

Study Completion (Actual)

October 25, 2019

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AG045157 (U.S. NIH Grant/Contract)
  • 1R01AG045157-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mild Cognitive Impairment

Clinical Trials on Combined Cognitive and Physical

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe