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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04120792
Other study ID # UA15-011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2015
Est. completion date November 20, 2017

Study information

Verified date May 2019
Source University of Arizona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date November 20, 2017
Est. primary completion date November 20, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 74 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
Cognitive Training
Participants in this arm will engage in a 12-week intervention that involves cognitive tablet-based training three times per week.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Arizona

Outcome

Type Measure Description Time frame Safety issue
Other Change from baseline in Wechsler Adult Intelligence Scale-IV Digit Span total score A measure of working memory Baseline, 6 weeks, 12 weeks
Other Change from baseline in Wechsler Adult Intelligence Scale-IV Coding total score A measure of information processing Baseline, 6 weeks, 12 weeks
Other Change from baseline in Wechsler Adult Intelligence Scale-IV Letter-Number Sequencing total score A measure of working memory Baseline, 6 weeks, 12 weeks
Other Change from baseline in Wechsler Memory Scale-IV Paired-Associates I total score A measure of verbal learning Baseline, 6 weeks, 12 weeks
Other Change from baseline in Auditory Verbal Learning Test total learning score A test of verbal list learning Baseline, 6 weeks, 12 weeks
Other Change from baseline in Trail Making Test, part A total time Tests of visuomotor tracking and complex attention Baseline, 6 weeks, 12 weeks
Other Change from baseline in Trail Making Test, part B total time Tests of visuomotor tracking and complex attention Baseline, 6 weeks, 12 weeks
Other 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
Other 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
Other 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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