Cognitive and Aerobic Resilience for the Brain

NCT02390453 | Completed DMC

• 2 other identifiers: R01AG0451571R01AG045157-01A1
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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).

Conditions

Mild Cognitive Impairment

Keywords

mild cognitive impairment; randomized controlled trial; cognitive training; exercise training; cognition; physical performance; disability; mood

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• Number of participants with study-related adverse events (AE) by treatment arm.

  From enrollment through end of treatment at 12-weeks.

Study Arms (4)

Combined Cognitive and Physical

EXPERIMENTAL

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

Cognitive

ACTIVE COMPARATOR

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

Behavioral: Cognitive

Physical

ACTIVE COMPARATOR

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

Behavioral: Physical

Active Control

ACTIVE COMPARATOR

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

Interventions

Combined Cognitive and Physical BEHAVIORAL

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.

Combined Cognitive and Physical

Cognitive BEHAVIORAL

Cognitive modules from Posit Science are designed to improve information processing speed, learning, memory, and attention.

Cognitive

Physical BEHAVIORAL

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.

Physical

Active Control BEHAVIORAL

Control modules provide social contact for group discussion of health and successful aging.

Active Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• subjective memory complaint
• minimal impairment in daily function per Functional Activity Questionnaire (FAQ)
• sedentary
• English speaking
• access to telephone

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Frederick W Unverzagt, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 17, 2015
• Study Start: January 1, 2015
• Primary Completion: October 25, 2019
• Study Completion: October 25, 2019
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

US (1)