Cognitive Regulation Training and Exercise

NCT01837004 | Completed

• 1 other identifier: 1R21HL11341001A1
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare CORTEX (Cognitive Regulation Training and Exercise), a multi-faceted, general and exercise-specific cognitive training program plus a 4-month exercise program, to an attention-control condition involving health and wellness informational lectures plus videos. The proposed exercise program will involve both aerobic and resistive exercises. The investigators hypothesize that pre-intervention cognitive training will enhance self-regulation and self-efficacy and in turn, increase exercise adherence. The investigators also expect more positive improvements in cognitive and psychosocial function among participants in the CORTEX condition as compared to the Control condition immediately following the cognitive booster training, and across time.

Conditions

Patient Compliance

Keywords

adherence; cognition; exercise; aging

Outcome Measures

Primary Outcomes (2)

• exercise adherence

  * number of weekly classes attended (out of 16 total) * frequency of electronically-recorded visits to the fitness facility

  4 months (from exercise intervention baseline to 4-month post-test)

• exercise program engagement

  * self-reported physical activity * activity counts assessed via accelerometer * weekly exercise logs * website usage \& percentage of online educational modules completed

  4 month period (exercise intervention start to end)

Secondary Outcomes (3)

• automaticity of exercise-related efficacy judgments

  5-month period

• exercise-related self-efficacy

  5-month period

• executive functioning

  5-month period

Study Arms (1)

CORTEX

EXPERIMENTAL

The CORTEX group will attend 10, 2-hour sessions for a period of four weeks prior to the initial exercise program start. One hour will be devoted to computerized training (stationary dual-task \& cognitive control training, self-priming, certainty training) whereas the other hour will be devoted to exergaming involving non-stationary, dual-task training.

Behavioral: CORTEX

Interventions

CORTEX BEHAVIORAL

2-hour sessions for a period of four weeks prior to the initial exercise program start. One hour will be devoted to computerized training (stationary dual-task \& cognitive control training, self-priming, certainty training) whereas the other hour will be devoted to exergaming involving non-stationary, dual-task training.

CORTEX

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• men and women
• between 45-64 years old at time of study
• physically inactive for the past 3 months
• have reliable access to internet
• do NOT own or play exergames (Xbox Kinect, Playstation Move, or Nintendo Wii) regularly
• do NOT engage in "brain-training" regularly
• are NOT enrolled in another exercise program or cognitive training study
• willing to be randomized
• able to participant in the full length of the 5-month study with no more than 2 consecutive weeks of vacation

You may not qualify if:

• \<45 or \>64 years of age at time of study
• physically active (i.e., planned 30-min walking or exercise \>2 days/wk)
• do not have reliable access to internet
• own and/or play exergames regularly (e.g., 1 day/wk)
• engage in "brain-training" regularly (e.g., Sudoku or computer game-play 1 day/wk)
• enrolled in another exercise program or cognitive training study
• cognitive impairment as defined by TICS score \<21
• depression as defined by Geriatric Depression Scale score \>5

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Illinois

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Patient Compliance; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Sean P Mullen, Ph.D.

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 22, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 10, 2014

Record last verified: 2014-03

Locations

US (1)