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OpenTrials
Completed

NCT Number: NCT04404621

Computer Presented and Physical Exercises to Maintain Cognitive Function and Emotional Health in Older Adults

The aim of this study is to investigate and compare how 18-weeks of computer-based brain training and physical exercise together can improve physical performance, cognitive function and mood in older adults in a cross-over design with participants randomized to receive the intervention first and then be assessed before and after an 18 week period without intervention, or the reverse sequence.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

About this study

The aim of this study is to investigate and compare how 18-weeks of computer-based brain training and physical exercise together can improve physical performance, cognitive function and mood in older adults in a cross-over design with participants randomized to receive the intervention first and then be assessed before and after an 18 week period without intervention, or the reverse sequence. 80 adults between the ages of 65 and 105 years old will be invited to participate. After providing informed consent, in the case of subjects who are living on units for individuals with memory or other cognitive compromise, after assent from the individual and approval from facility staff, subjects will be randomly assigned to either receive the intervention for 18 weeks and then be followed for an additional 18 weeks, or to be followed for 18 weeks without intervention and then do the intervention for 18 weeks. The intervention will consist of 18 weeks of 60-minute PE sessions 3-4 times/week and 25-minute CBB training sessions 3-4 times a week.

There will be 3 assessments of participants: before and after the first 18-week period and then again after the second 18-week period. Assessments will be done in 2 sessions over a total of 90 minutes and will include demographic, health, physical activity and social activity questionnaires as well as the self-report measures of cognitive function, emotional state and weekly activities; quantitative assessments of physical balance, strength, flexibility blood pressure and heart rate; and tests of cognitive function. Subject medications will be recorded at each assessment. The wait-list control group will receive the same assessments at the same time points.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Associated with Whitney center as residents or participants in non-resident programs.
  • Able to understand and read English.

Exclusion criteria

  • Not able to sit in a chair independently.
  • Not able to move both arms in simple movement sequence.
  • Hearing and vision insufficient to do the computer exercises or follow the PE instructions.
  • Not able to remember 3 movements in succession.

Treatment and study plan

Physical exercise (PE) training and computer-based brain (CBB)

Behavioral

18 weeks of PE and CBB.

Primary outcomes

  1. Composite cognition score

    Time frame: 18 weeks

    Composite from: Flanker Test of Attention; Go/No-Go Test of Response Inhibition; List Sort Working Memory Test; Logical Memory Story Recall; Digit symbol coding; Digit Span Forwards and Backwards; Hopkin's Verbal Learning Test; Trail Making B; Stroop Color Word; Category Verbal Fluency; Reaction Time.

    A composite score will be calculated for each participant at baseline and after training and waitlist periods by first determining Z-scores for each test for each participant at each time point based on means and standard deviations for the entire sample at baseline, and then averaging the individual's Z-scores at that time point.

  2. Sit to Stand in one-minute

    Time frame: 18 weeks

    Number of times able to go from sit to stand in in one minute

  3. Balance - stand on one foot at a time

    Time frame: 18 weeks

    Stand on one foot with the toe of the other foot touching the calf of the standing leg - number of seconds able to maintain. The sum of right and leg foot will be added.

  4. Mood and Quality of Life

    Time frame: 18 weeks

    Composite score from WHODAS, DEMQ QLI and Beck Depression Inventory.

    A composite score will be calculated for each participant at baseline and after training and waitlist periods by first determining Z-scores for total score on each questionnaire for each participant at each time point based on means and standard deviations for the entire sample at baseline, and then averaging the individual's Z-scores at that time point.

Secondary outcomes

  1. Attention and Speed of Processing

    Time frame: 18 weeks

    Flanker Test of Attention (average reaction time on correct incongruent trials)

  2. Response Inhibition

    Time frame: 18 weeks

    Percent correct on no-go trials on Go/No-Go Test

  3. Working Memory

    Time frame: 18 weeks

    Average z-scores on two tests of working memory: 1)List Sorting Working Memory (total score which is the sum of scores on parts one and two) and Digit Span (sum of longest span forward and longest span backwards)

  4. Verbal Memory

    Time frame: 18 weeks

    Logical Memory Story Recall (number of details correctly recalled on initial recall)

  5. Speed of Processing

    Time frame: 18 weeks

    Digit Symbol Coding (number of correct responses in 60 seconds)

  6. Cognitive Flexibility

    Time frame: 18 weeks

    Color/Word Stroop Test (Time to read words in conflicting colors minus time to read words without conflicting colors

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 27, 2020
Registry last updated
Jun 14, 2021

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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