Cognitive and Aerobic Resilience for the Brain (CARB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02390453|
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : June 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Behavioral: Combined Cognitive and Physical Behavioral: Cognitive Behavioral: Physical Behavioral: Control||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Cognitive and Aerobic Resilience for the Brain|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||October 25, 2019|
|Actual Study Completion Date :||October 25, 2019|
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).
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).
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.
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).
Control modules provide social contact for group discussion and instruction in health self-management and successful aging.
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390453
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Frederick W Unverzagt, PhD||Indiana University|