The Aerobic and Cognitive Training System

The Aerobic and Cognitive Training System to Improve Cognition

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.

Study Overview

• Status: Completed
• Conditions: Healthy Aging
• Intervention / Treatment: Behavioral: Simultaneous exercise and cognitive training; Behavioral: Exercise training; Behavioral: Cognitive Training; Behavioral: Neutral video

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simultaneous exercise and cognitive training; Participants in this arm will engage in a 12-week intervention that combines physical exercise and cognitive tablet-based training. This intervention involves use of an exercise bicycle while engaging in cognitive tasks on a tablet computer three times per week.	Behavioral: Simultaneous exercise and cognitive training; Participants in this arm will engage in a 12-week intervention that combines physical exercise and cognitive tablet-based training. This intervention involves use of an exercise bicycle while engaging in cognitive tasks on a tablet computer three times per week.
Active Comparator: Exercise training; Participants in this arm will engage in a 12-week exercise intervention that involves use of an exercise bicycle three times per week.	Behavioral: Exercise training; Participants in this arm will engage in a 12-week exercise intervention that involves use of an exercise bicycle three times per week.
Active Comparator: Cognitive training; Participants in this arm will engage in a 12-week intervention that involves cognitive tablet-based training three times per week.	Behavioral: Cognitive Training; Participants in this arm will engage in a 12-week intervention that involves cognitive tablet-based training three times per week.
Active Comparator: Neutral Video; Participants in this arm will engage in a 12-week intervention that involves watching neutral videos on a tablet computer three times per week.	Behavioral: Neutral video; Participants in this arm will engage in a 12-week intervention that involves watching neutral videos on a tablet computer three times per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in cognitive function during dual-task test at 12 weeks	Performance on serial subtraction during dual-task walking.	Baseline and 12-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in stride length during dual-task test	The difference between stride length in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks	Baseline, 6 weeks, 12 weeks
Change from baseline in stride duration during dual-task test	The difference between stride duration in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks	Baseline, 6 weeks, 12 weeks
Change from baseline in stride velocity during dual-task test	The difference between stride velocity in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks	Baseline, 6 weeks, 12 weeks
Change from baseline in stride length variability during dual-task test	The difference between stride length variability (measured by coefficient of variation) in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks	Baseline, 6 weeks, 12 weeks
Change from baseline in stride duration variability during dual-task test	The difference between stride duration variability (measured by coefficient of variation) in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks	Baseline, 6 weeks, 12 weeks
Change from baseline in stride velocity variability during dual-task test	The difference between stride velocity variability (measured by coefficient of variation) in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks	Baseline, 6 weeks, 12 weeks
Change from baseline in cognitive function during dual-task test at 6 weeks	Performance on serial subtraction during dual-task walking.	Baseline and 6-weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Wechsler Adult Intelligence Scale-IV Digit Span total score	A measure of working memory	Baseline, 6 weeks, 12 weeks
Change from baseline in Wechsler Adult Intelligence Scale-IV Coding total score	A measure of information processing	Baseline, 6 weeks, 12 weeks
Change from baseline in Wechsler Adult Intelligence Scale-IV Letter-Number Sequencing total score	A measure of working memory	Baseline, 6 weeks, 12 weeks
Change from baseline in Wechsler Memory Scale-IV Paired-Associates I total score	A measure of verbal learning	Baseline, 6 weeks, 12 weeks
Change from baseline in Auditory Verbal Learning Test total learning score	A test of verbal list learning	Baseline, 6 weeks, 12 weeks
Change from baseline in Trail Making Test, part A total time	Tests of visuomotor tracking and complex attention	Baseline, 6 weeks, 12 weeks
Change from baseline in Trail Making Test, part B total time	Tests of visuomotor tracking and complex attention	Baseline, 6 weeks, 12 weeks
Change from baseline in Stroop Color and Word Test Color/Word Interference total score	A test to assess inhibition when reading color words	Baseline, 6 weeks, 12 weeks
Change from baseline in Deary-Liewald Reaction Time Task Simple median response time	Tests to measure speed of information processing	Baseline, 6 weeks, 12 weeks
Change from baseline in Deary-Liewald Reaction Time Task Choice median correct response time	Tests to measure speed of information processing	Baseline, 6 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Gene Alexander, University of Arizona; Principal Investigator: David Raichlen, University of Arizona

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): November 20, 2017
• Study Completion (Actual): November 20, 2017

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): October 9, 2019
• Last Update Submitted That Met QC Criteria: October 7, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: UA15-011