Cognitive Regulation Training and Exercise

NCT ID: NCT01837004

Last Updated: 2014-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-08-31

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.

Detailed Description

Primary Aim 1: To determine the efficacy of pre-intervention cognitive training for improving exercise adherence and engagement. We hypothesize that class participation rates, physical activity counts, and self-reported exercise participation levels will be higher at 4 months for participants in the CORTEX condition relative to the Control condition. We also predict that pre-intervention training will demonstrate high feasibility/acceptability, as indicated by a thorough process evaluation.

Primary Aim 2: To determine if integrated general and exercise-specific cognitive training improves facets of executive function and exercise-related efficacy judgments. We hypothesize that participants in the CORTEX condition will show faster reaction times and greater accuracy for trained and untrained-domain-relevant tasks, including dual task performance, reasoning, and thought-stopping at post-booster testing and 4-month follow-up. Furthermore, we hypothesize that CORTEX participants will show significantly higher levels of exercise efficacy judgments, and exhibit greater automaticity (faster reaction times) in making those judgments, at post-booster testing, 1 month and 4-month follow-up.

Secondary Aim 1: We will use longitudinal mediation analyses to examine mechanisms of change brought about by the cognitive training effects on exercise adherence and engagement. We hypothesize that changes in efficacy and use of self-regulatory strategies will mediate cognitive training effects on exercise adherence over 4-months.

Conditions

Patient Compliance

Keywords

adherence; cognition; exercise; aging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CORTEX

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.

Group Type: EXPERIMENTAL

CORTEX

Intervention Type: 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.

Interventions

CORTEX

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• <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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean P Mullen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Urbana-Champaign

Locations

University of Illinois

Urbana, Illinois, United States

Countries

United States

Other Identifiers

1R21HL11341001A1

Identifier Type: -

Identifier Source: org_study_id