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.

Study Overview

• Status: Completed
• Conditions: Cognitive Function; Depression in Old Age
• Intervention / Treatment: Behavioral: Physical exercise (PE) training and computer-based brain (CBB)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Connecticut Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cross-Over Sequence A; Participants in this arm will be randomized to receive the 18 week program first and be in treatment as usual comparison condition in the following 18 weeks.	Behavioral: Physical exercise (PE) training and computer-based brain (CBB); 18 weeks of PE and CBB.
Experimental: Cross-Over Sequence B; Participants in this arm will be randomized to remain in treatment as usual during the first 18 week period and then receive the 18 week program during the following 18 weeks.	Behavioral: Physical exercise (PE) training and computer-based brain (CBB); 18 weeks of PE and CBB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite cognition score	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.	18 weeks
Sit to Stand in one-minute	Number of times able to go from sit to stand in in one minute	18 weeks
Balance - stand on one foot at a time	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.	18 weeks
Mood and Quality of Life	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.	18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attention and Speed of Processing	Flanker Test of Attention (average reaction time on correct incongruent trials)	18 weeks
Response Inhibition	Percent correct on no-go trials on Go/No-Go Test	18 weeks
Working Memory	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)	18 weeks
Verbal Memory	Logical Memory Story Recall (number of details correctly recalled on initial recall)	18 weeks
Speed of Processing	Digit Symbol Coding (number of correct responses in 60 seconds)	18 weeks
Cognitive Flexibility	Color/Word Stroop Test (Time to read words in conflicting colors minus time to read words without conflicting colors	18 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Bruce E Wexler, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Actual): September 12, 2020
• Study Completion (Actual): September 12, 2020

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2000026437

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No