Computer Presented and Physical Exercises to Maintain Cognitive Function and Emotional Health in Older Adults
Primary Purpose
Cognitive Function, Depression in Old Age
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical exercise (PE) training and computer-based brain (CBB)
Sponsored by
About this trial
This is an interventional basic science trial for Cognitive Function
Eligibility Criteria
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.
Sites / Locations
- Connecticut Mental Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cross-Over Sequence A
Cross-Over Sequence B
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Sit to Stand in one-minute
Number of times able to go from sit to stand in in one minute
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.
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.
Secondary Outcome Measures
Attention and Speed of Processing
Flanker Test of Attention (average reaction time on correct incongruent trials)
Response Inhibition
Percent correct on no-go trials on Go/No-Go Test
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)
Verbal Memory
Logical Memory Story Recall (number of details correctly recalled on initial recall)
Speed of Processing
Digit Symbol Coding (number of correct responses in 60 seconds)
Cognitive Flexibility
Color/Word Stroop Test (Time to read words in conflicting colors minus time to read words without conflicting colors
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04404621
Brief Title
Computer Presented and Physical Exercises to Maintain Cognitive Function and Emotional Health in Older Adults
Official Title
Computer Presented and Physical Exercises to Maintain Cognitive Function and Emotional Health in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
September 12, 2020 (Actual)
Study Completion Date
September 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Function, Depression in Old Age
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cross-Over Sequence A
Arm Type
Experimental
Arm Description
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.
Arm Title
Cross-Over Sequence B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical exercise (PE) training and computer-based brain (CBB)
Intervention Description
18 weeks of PE and CBB.
Primary Outcome Measure Information:
Title
Composite cognition score
Description
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.
Time Frame
18 weeks
Title
Sit to Stand in one-minute
Description
Number of times able to go from sit to stand in in one minute
Time Frame
18 weeks
Title
Balance - stand on one foot at a time
Description
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.
Time Frame
18 weeks
Title
Mood and Quality of Life
Description
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.
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Attention and Speed of Processing
Description
Flanker Test of Attention (average reaction time on correct incongruent trials)
Time Frame
18 weeks
Title
Response Inhibition
Description
Percent correct on no-go trials on Go/No-Go Test
Time Frame
18 weeks
Title
Working Memory
Description
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)
Time Frame
18 weeks
Title
Verbal Memory
Description
Logical Memory Story Recall (number of details correctly recalled on initial recall)
Time Frame
18 weeks
Title
Speed of Processing
Description
Digit Symbol Coding (number of correct responses in 60 seconds)
Time Frame
18 weeks
Title
Cognitive Flexibility
Description
Color/Word Stroop Test (Time to read words in conflicting colors minus time to read words without conflicting colors
Time Frame
18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce E Wexler
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Computer Presented and Physical Exercises to Maintain Cognitive Function and Emotional Health in Older Adults
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