The Aerobic and Cognitive Training System

• ClinicalTrials.gov Identifier: NCT04120792
• Recruitment Status: Completed
• First Posted: October 9, 2019
• Last Update Posted: October 9, 2019
• Sponsor: University of Arizona
• Information provided by (Responsible Party): University of Arizona

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Aging	Behavioral: Simultaneous exercise and cognitive training; Behavioral: Exercise training; Behavioral: Cognitive Training; Behavioral: Neutral video	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: The Aerobic and Cognitive Training System to Improve Cognition
• Actual Study Start Date: May 1, 2015
• Actual Primary Completion Date: November 20, 2017
• Actual Study Completion Date: November 20, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in cognitive function during dual-task test at 12 weeks [ Time Frame: Baseline and 12-weeks ]
   Performance on serial subtraction during dual-task walking.

Secondary Outcome Measures :

1. Change from baseline in stride length during dual-task test [ Time Frame: Baseline, 6 weeks, 12 weeks ]
   The difference between stride length in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks
2. Change from baseline in stride duration during dual-task test [ Time Frame: Baseline, 6 weeks, 12 weeks ]
   The difference between stride duration in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks
3. Change from baseline in stride velocity during dual-task test [ Time Frame: Baseline, 6 weeks, 12 weeks ]
   The difference between stride velocity in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks
4. Change from baseline in stride length variability during dual-task test [ Time Frame: Baseline, 6 weeks, 12 weeks ]
   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
5. Change from baseline in stride duration variability during dual-task test [ Time Frame: Baseline, 6 weeks, 12 weeks ]
   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
6. Change from baseline in stride velocity variability during dual-task test [ Time Frame: Baseline, 6 weeks, 12 weeks ]
   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
7. Change from baseline in cognitive function during dual-task test at 6 weeks [ Time Frame: Baseline and 6-weeks ]
   Performance on serial subtraction during dual-task walking.

Other Outcome Measures:

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

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 74 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Sponsors and Collaborators

University of Arizona

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Arizona
• ClinicalTrials.gov Identifier: NCT04120792
• Other Study ID Numbers: UA15-011
• First Posted: October 9, 2019
• Last Update Posted: October 9, 2019
• Last Verified: May 2019