Clinical trial NCT01837004: Cognitive Regulation Training and Exercise
Official title: Cognitive Regulation Training and Exercise (CORTEX) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Compliance
Keywords: adherence
cognition
exercise
aging
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-04-22
Enrollment: 133
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: exercise adherence
timeFrame: 4 months (from exercise intervention baseline to 4-month post-test)
measure: exercise program engagement
timeFrame: 4 month period (exercise intervention start to end)
Secondary outcomes:
measure: automaticity of exercise-related efficacy judgments
timeFrame: 5-month period
measure: exercise-related self-efficacy
timeFrame: 5-month period
measure: executive functioning
timeFrame: 5-month period
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Sean P Mullen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: