Clinical trial NCT04404621: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Depression in Old Age
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 34
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Composite cognition score
timeFrame: 18 weeks
measure: Sit to Stand in one-minute
timeFrame: 18 weeks
measure: Balance - stand on one foot at a time
timeFrame: 18 weeks
measure: Mood and Quality of Life
timeFrame: 18 weeks
Secondary outcomes:
measure: Attention and Speed of Processing
timeFrame: 18 weeks
measure: Response Inhibition
timeFrame: 18 weeks
measure: Working Memory
timeFrame: 18 weeks
measure: Verbal Memory
timeFrame: 18 weeks
measure: Speed of Processing
timeFrame: 18 weeks
measure: Cognitive Flexibility
timeFrame: 18 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Bruce E Wexler
role: PRINCIPAL_INVESTIGATOR
References: