Cognitive Regulation Training and Exercise (CORTEX)
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|ClinicalTrials.gov Identifier: NCT01837004|
Recruitment Status : Completed
First Posted : April 22, 2013
Last Update Posted : December 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Patient Compliance||Behavioral: CORTEX||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||133 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Cognitive Regulation Training and Exercise (CORTEX) Trial|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
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.
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.
- exercise adherence [ Time Frame: 4 months (from exercise intervention baseline to 4-month post-test) ]
- number of weekly classes attended (out of 16 total)
- frequency of electronically-recorded visits to the fitness facility
- exercise program engagement [ Time Frame: 4 month period (exercise intervention start to end) ]
- self-reported physical activity
- activity counts assessed via accelerometer
- weekly exercise logs
- website usage & percentage of online educational modules completed
- automaticity of exercise-related efficacy judgments [ Time Frame: 5-month period ]-reaction times and interference associated with a novel self-efficacy judgment task; collected at baseline, m1, and m5
- exercise-related self-efficacy [ Time Frame: 5-month period ]-self-reported confidence in one's ability to adhere to different aspects of the exercise program; collected at baseline, m1, m2, and m5
- executive functioning [ Time Frame: 5-month period ]-trained and untrained domains of executive functioning (e.g., dual-task ability, inhibitory control, reasoning) and memory assessed via computer-based and pencil-paper tasks; collected at baseline, 1m, and 5m
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837004
|United States, Illinois|
|University of Illinois|
|Urbana, Illinois, United States, 61801|
|Principal Investigator:||Sean P Mullen, Ph.D.||University of Illinois at Urbana-Champaign|