Cognitive Regulation Training and Exercise

Patient Compliance Clinical Trial

— CORTEX  

Official title:

Cognitive Regulation Training and Exercise (CORTEX) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837004
• Other study ID #: 1R21HL11341001A1
• Status: Completed
• Phase: N/A
• First received: April 17, 2013
• Last updated: December 8, 2014
• Start date: January 2013
• Est. completion date: August 2014

Study information

• Verified date: March 2014
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 64 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Patient Compliance

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Illinois	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	automaticity of exercise-related efficacy judgments	-reaction times and interference associated with a novel self-efficacy judgment task; collected at baseline, m1, and m5	5-month period	No
Secondary	exercise-related self-efficacy	-self-reported confidence in one's ability to adhere to different aspects of the exercise program; collected at baseline, m1, m2, and m5	5-month period	No
Secondary	executive functioning	-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	5-month period	No