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Completed

NCT Number: NCT04120792

The Aerobic and Cognitive Training System

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.

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Key information

Conditions

Healthy Aging

Age range

60 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Simultaneous exercise and cognitive training

Behavioral

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

Behavioral

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

Behavioral

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

Neutral video

Behavioral

Participants in this arm will engage in a 12-week intervention that involves watching neutral videos on a tablet computer three times per week.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

The Aerobic and Cognitive Training System to Improve Cognition

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 9, 2019
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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