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The Aerobic and Cognitive Training System

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

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

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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

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.




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



Information from the National Library of Medicine

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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120792


Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Gene Alexander University of Arizona
Principal Investigator: David Raichlen University of Arizona
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT04120792    
Other Study ID Numbers: UA15-011
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: May 2019