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

NCT ID: NCT04404621

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-13
• Study Completion Date: 2020-09-12

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.

Conditions

Cognitive Function; Depression in Old Age

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

18 weeks of PE and CBB.

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

18 weeks of PE and CBB.

Interventions

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

18 weeks of PE and CBB.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce E Wexler

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Connecticut Mental Health Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

2000026437

Identifier Type: -

Identifier Source: org_study_id