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

NCT04404621 | Completed

• 1 other identifier: 2000026437
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Function; Depression in Old Age

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Attention and Speed of Processing

  18 weeks

• Response Inhibition

  18 weeks

• Working Memory

  18 weeks

• Verbal Memory

  18 weeks

• Speed of Processing

  18 weeks

Study Arms (2)

Cross-Over Sequence A

EXPERIMENTAL

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)

Cross-Over Sequence B

EXPERIMENTAL

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)

Interventions

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

18 weeks of PE and CBB.

Cross-Over Sequence A; Cross-Over Sequence B

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bruce E Wexler

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 27, 2020
• Study Start: November 13, 2019
• Primary Completion: September 12, 2020
• Study Completion: September 12, 2020
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)