Cognitive Regulation Training and Exercise Trial

NCT03124667 | Completed

• 3 other identifiers: 16447GRANT120530541R01AG052707-01A1
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this double-blinded, randomized controlled study is to compare CORTEX (Cognitive Regulation Training and Exercise), a multi-faceted, center- and home-delivered- general and exercise-specific-active and traditional computerized cognitive training (CT) program to an attention-control condition involving health and wellness informational videos. More specifically, the cognitive training group will emphasize dual-task abilities, working memory, and visual-spatial processing, as well as self-as-exerciser priming and self-certainty training. It is hypothesized that early intervention cognitive training will enhance use of self-regulatory strategies and self-efficacy and in turn, increase exercise adherence to and engagement in a 12-month aerobic and resistive exercise program at a local fitness facility. More positive improvements in cognitive and psychosocial functioning among participants in the CORTEX condition (relative to the Video Attention-Control condition, i.e., health educational videos), are also expected immediately following the cognitive training, and across time. Expectancies and knowledge of study purpose (blinding integrity) will also be measured and used to statistically adjust for any training differences.

Conditions

Patient Compliance

Keywords

adherence; cognition; exercise; aging; brain training; cognitive training; executive function

Outcome Measures

Primary Outcomes (1)

• Exercise self-regulation

  Exercise self-regulation will be modeled within a latent variable framework. The change factor will be reflected by accumulated supervised and unsupervised class participation rates, total electronically-recorded visitations, averaged monthly Fitbit-derived step counts, and self-reported leisure-time exercise (via Godin Leisure-Time Questionnaire). Measures will be standardized as z-scores. The latent factor model will be adjusted for known covariates (age, gender, education level, training compliance \[percentage of completed sessions\] and injury/illness) when primary hypothesis of group effects is tested. There is always the possibility that attempts to analyze latent constructs will not converge as planned. In such a case, researchers will attempt to assess change across each behavioral outcome individually with a robust linear regression method, adjusting for multiple comparisons.

  12 months

Secondary Outcomes (6)

• Dual task functioning (change)

  1 month

• Memory functioning (change)

  1 month

• Exercise self-efficacy (change)

  1 month

• Physical activity self-regulatory strategy-use (change)

  1 month

• Exercise planning (change)

  1 month

Study Arms (2)

Gaming Condition

EXPERIMENTAL

The games group will visit the lab on 5 separate occasions, for 2 hours each, to complete training sessions (playing seated and standing computerized games), and then complete 5 similar sessions at home (lasting 2 hours, but may be split into 1-hour sessions at their convenience), at the onset of the exercise program. The training sessions will be scheduled concurrently with exercise classes in the first month. This group will also be asked to accumulate 150 minutes of exercise by attending weekly supervised and unsupervised, group-based aerobic and resistance exercise classes, by visiting the fitness facility alone, and by walking or strength training at home when necessary to supplement fitness facility activities to fully meet public health recommendations, for a period of 12 months.

Behavioral: Games

Video Condition

ACTIVE COMPARATOR

The videos group will visit the lab on 5 separate occasions, for 2 hours each, to view health and educational YouTube videos, and then view 5 similar sessions at home (lasting 2 hours, but may be split into 1-hour sessions at their convenience), at the onset of the exercise program. The training sessions will be scheduled concurrently with exercise classes in the first month. This group will also be asked to accumulate 150 minutes of exercise by attending weekly supervised and unsupervised, group-based aerobic and resistance exercise classes, by visiting the fitness facility alone, and by walking or strength training at home when necessary to supplement fitness facility activities to fully meet public health recommendations, for a period of 12 months.

Behavioral: Videos

Interventions

Games BEHAVIORAL

The game training will emphasize general and exercise-specific dual task processing, self-priming and certainty training.

Also known as: Gaming Condition

Gaming Condition

Videos BEHAVIORAL

The video training will emphasize health and educational information.

Also known as: Video Condition

Video Condition

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women
• Low active for the past 3 months
• to 64 years old
• Do NOT regularly play exergames (e.g., XBox Kinect, Playstation Move, Nintendo Wii)
• Do NOT engage in "brain training" regularly (less than once per week)
• Are NOT enrolled in another exercise program or cognitive training study
• Able and willing to comply with the study length, testing, training and exercise program requirements
• Lives within 20 miles of the fitness facility and UIUC research facility
• Has reliable at-home Wi-Fi internet access and an available port for plugging in XBox console
• Vision is at least 20/40 with glasses or contacts with no color blindness
• Do NOT have depression (as defined by a score of 2 or less on the abbreviated Geriatric Depression Scale \[GDS-5\])
• Do NOT have cognitive impairment (as defined by a score of 21 or higher on the Telephone Interview Cognitive Survey \[TICS\])

You may not qualify if:

• Previously involved in the first CORTEX trial
• Currently involved in regular weekly cognitive training or another physical activity program or study (e.g., yoga, meditation)
• Too active (as defined by regularly exercise 2 or more days per week for 30+ minutes over the past 3 months)
• Incapable of performing moderately intensive aerobic exercise (must be able to complete basic movements, i.e., walking, jogging, jumping, side-stepping, throwing, kicking, punching, grabbing) without exacerbating a pre-existing condition caused by overuse, surgery, or other chronic condition
• Unable or unwilling to comply to lab and home-based training and physical activity prescription
• Unable to commit to full length of program
• Unwilling to be randomized to one of two groups
• Home residence exceeds 20 mile radius from fitness facility or unable to commute to and from fitness facility and UIUC campus
• Do not have reliable at-home Wi-Fi internet access or a required port for plugging in Xbox
• Uncorrectable vision (i.e., less than 20/40 with glasses or contacts with color blindness)
• Depression as defined by GDS \>2
• Cognitive impairment as defined by TICS \< 21

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Illinois

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Patient Compliance; Motor Activity

Interventions

Games, Experimental; Videotape Recording

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques; Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Sean P Mullen, PhD

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 24, 2017
• Study Start: January 1, 2017
• Primary Completion: May 31, 2020
• Study Completion: October 10, 2020
• Last Updated: December 10, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)