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Cognitive and Aerobic Resilience for the Brain (CARB)

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Combined Cognitive and Physical
Cognitive
Physical
Active Control
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring mild cognitive impairment, randomized controlled trial, cognitive training, exercise training, cognition, physical performance, disability, mood

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Combined Cognitive and Physical

Cognitive

Physical

Active Control

Arm Description

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).

This consists of 45 minutes of cognitive modules from Posit Science, 3 days a week for 12 weeks (36 sessions).

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

This consists of 45 minutes of group discussion of health and successful aging, 2 days a week for 12 weeks (24 sessions).

Outcomes

Primary Outcome Measures

Cognitive function composite score as measured by individually-administered tests of psychomotor speed, complex sequencing, and list learning.
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.
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.
Number of training sessions attended divided by the the total number of sessions available.
Participant adherence to outcome assessment.
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.

Secondary Outcome Measures

Full Information

First Posted
March 5, 2015
Last Updated
March 6, 2023
Sponsor
Indiana University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT02390453
Brief Title
Cognitive and Aerobic Resilience for the Brain
Acronym
CARB
Official Title
Cognitive and Aerobic Resilience for the Brain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
October 25, 2019 (Actual)
Study Completion Date
October 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
mild cognitive impairment, randomized controlled trial, cognitive training, exercise training, cognition, physical performance, disability, mood

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined Cognitive and Physical
Arm Type
Experimental
Arm Description
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).
Arm Title
Cognitive
Arm Type
Active Comparator
Arm Description
This consists of 45 minutes of cognitive modules from Posit Science, 3 days a week for 12 weeks (36 sessions).
Arm Title
Physical
Arm Type
Active Comparator
Arm Description
This consists of 45 minutes of multi-modal physical exercise, 3 days a week for 12 weeks (36 sessions).
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
This consists of 45 minutes of group discussion of health and successful aging, 2 days a week for 12 weeks (24 sessions).
Intervention Type
Behavioral
Intervention Name(s)
Combined Cognitive and Physical
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive
Intervention Description
Cognitive modules from Posit Science are designed to improve information processing speed, learning, memory, and attention.
Intervention Type
Behavioral
Intervention Name(s)
Physical
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Control
Intervention Description
Control modules provide social contact for group discussion of health and successful aging.
Primary Outcome Measure Information:
Title
Cognitive function composite score as measured by individually-administered tests of psychomotor speed, complex sequencing, and list learning.
Description
The cognitive composite is derived from: WAIS-IV Symbol Search, Trail Making Test Part B, and Rey Auditory Verbal Learning Test.
Time Frame
End of treatment at 12-weeks.
Title
Average participant self-ratings of intervention acceptability.
Description
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.
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.
Title
Participant adherence to treatment.
Description
Number of training sessions attended divided by the the total number of sessions available.
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.
Title
Participant adherence to outcome assessment.
Description
Number of participants completing the post-training outcome assessment divided by the total number randomized.
Time Frame
End of treatment at 12-weeks.
Title
Number of participants with study-related adverse events (AE) by treatment arm.
Time Frame
From enrollment through end of treatment at 12-weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick W Unverzagt, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

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Cognitive and Aerobic Resilience for the Brain

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