Cognitive and Aerobic Resilience for the Brain

Mild Cognitive Impairment Clinical Trial

— CARB  

Official title:

Cognitive and Aerobic Resilience for the Brain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390453
• Other study ID #: R01AG045157
• Secondary ID: 1R01AG045157-01A
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: October 25, 2019

Study information

• Verified date: March 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: October 25, 2019
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• 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.
• Cognitive
Cognitive modules from Posit Science are designed to improve information processing speed, learning, memory, and attention.
• 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 Control
Control modules provide social contact for group discussion of health and successful aging.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	End of treatment at 12-weeks.
Primary	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.	From date of randomization until the date of the final training session or the end of the 12-week intervention, whichever came first.
Primary	Participant adherence to treatment.	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.
Primary	Participant adherence to outcome assessment.	Number of participants completing the post-training outcome assessment divided by the total number randomized.	End of treatment at 12-weeks.
Primary	Number of participants with study-related adverse events (AE) by treatment arm.		From enrollment through end of treatment at 12-weeks.