Clinical trial NCT04120792: The Aerobic and Cognitive Training System
Official title: The Aerobic and Cognitive Training System to Improve Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Aging
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 74
Sex: ALL
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will determine the effects of simultaneous exercise and cognitive training on cognitive function in healthy older adults. Specifically, this study will compare the use of a tablet-based cognitive training system while exercising with exercise alone, cognitive training alone, and a neutral control condition on cognition.


Eligibility criteria: Inclusion Criteria:

Generally healthy, age 60-74, and a written statement from their primary care physician indicating that they are able to participate in the 12-week exercise program.

Exclusion Criteria:

Subjects will be excluded from participating in the study if they express significant concerns about their memory or declines in other cognitive abilities, if they are not English speaking, or if they have histories of significant major neurological, psychiatric, or medical disorder or injury that would affect cognitive function.

Primary outcomes:
measure: Change from baseline in cognitive function during dual-task test at 12 weeks
timeFrame: Baseline and 12-weeks
Secondary outcomes:
measure: Change from baseline in stride length during dual-task test
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change from baseline in stride duration during dual-task test
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change from baseline in stride velocity during dual-task test
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change from baseline in stride length variability during dual-task test
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change from baseline in stride duration variability during dual-task test
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change from baseline in stride velocity variability during dual-task test
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change from baseline in cognitive function during dual-task test at 6 weeks
timeFrame: Baseline and 6-weeks
Other outcomes:
measure: Change from baseline in Wechsler Adult Intelligence Scale-IV Digit Span total score
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change from baseline in Wechsler Adult Intelligence Scale-IV Coding total score
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change from baseline in Wechsler Adult Intelligence Scale-IV Letter-Number Sequencing total score
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change from baseline in Wechsler Memory Scale-IV Paired-Associates I total score
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change from baseline in Auditory Verbal Learning Test total learning score
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change from baseline in Trail Making Test, part A total time
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change from baseline in Trail Making Test, part B total time
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change from baseline in Stroop Color and Word Test Color/Word Interference total score
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change from baseline in Deary-Liewald Reaction Time Task Simple median response time
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change from baseline in Deary-Liewald Reaction Time Task Choice median correct response time
timeFrame: Baseline, 6 weeks, 12 weeks
Locations:
Study officials:
affiliation: University of Arizona
name: Gene Alexander
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: David Raichlen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raichlen DA, Bharadwaj PK, Nguyen LA, Franchetti MK, Zigman EK, Solorio AR, Alexander GE. Effects of simultaneous cognitive and aerobic exercise training on dual-task walking performance in healthy older adults: results from a pilot randomized controlled trial. BMC Geriatr. 2020 Mar 2;20(1):83. doi: 10.1186/s12877-020-1484-5.