Patient ComplianceCORTEX-IINCT03124667
Cognitive Regulation Training and Exercise Trial
A study testing Games and Videos in people with Patient Compliance, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The purpose of this double-blinded, randomized controlled study is to compare CORTEX (Cognitive Regulation Training and Exercise), a multi-faceted, center- and home-delivered- general and exercise-specific-active and traditional computerized cognitive training (CT) program to an attention-control condition involving… Read more about this study
- Who is it for?
- Ages 35 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Compliance
- What is being tested?
- Games and Videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 10 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women
- Low active for the past 3 months
- 35 to 64 years old
- Do NOT regularly play exergames (e.g., XBox Kinect, Playstation Move, Nintendo Wii)
- Do NOT engage in "brain training" regularly (less than once per week)
- Are NOT enrolled in another exercise program or cognitive training study
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- Able and willing to comply with the study length, testing, training and exercise program requirements
- Lives within 20 miles of the fitness facility and UIUC research facility
- Has reliable at-home Wi-Fi internet access and an available port for plugging in XBox console
- Vision is at least 20/40 with glasses or contacts with no color blindness
- Do NOT have depression (as defined by a score of 2 or less on the abbreviated Geriatric Depression Scale [GDS-5])
- Do NOT have cognitive impairment (as defined by a score of 21 or higher on the Telephone Interview Cognitive Survey [TICS])
Who cannot join
- Previously involved in the first CORTEX trial
- Currently involved in regular weekly cognitive training or another physical activity program or study (e.g., yoga, meditation)
- Too active (as defined by regularly exercise 2 or more days per week for 30+ minutes over the past 3 months)
- Incapable of performing moderately intensive aerobic exercise (must be able to complete basic movements, i.e., walking, jogging, jumping, side-stepping, throwing, kicking, punching, grabbing) without exacerbating a pre-existing condition caused by overuse, surgery, or other chronic condition
- Unable or unwilling to comply to lab and home-based training and physical activity prescription
- Unable to commit to full length of program
Show all 12Show fewer
- Unwilling to be randomized to one of two groups
- Home residence exceeds 20 mile radius from fitness facility or unable to commute to and from fitness facility and UIUC campus
- Do not have reliable at-home Wi-Fi internet access or a required port for plugging in Xbox
- Uncorrectable vision (i.e., less than 20/40 with glasses or contacts with color blindness)
- Depression as defined by GDS >2
- Cognitive impairment as defined by TICS < 21
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Regulation Training and Exercise (CORTEX)-II With Middle-Aged Adults
The purpose of this double-blinded, randomized controlled study is to compare CORTEX (Cognitive Regulation Training and Exercise), a multi-faceted, center- and home-delivered- general and exercise-specific-active and traditional computerized cognitive training (CT) program to an attention-control condition involving health and wellness informational videos. More specifically, the cognitive training group will emphasize dual-task abilities, working memory, and visual-spatial processing, as well as self-as-exerciser priming and self-certainty training. It is hypothesized that early intervention cognitive training will enhance use of self-regulatory strategies and self-efficacy and in turn, increase exercise adherence to and engagement in a 12-month aerobic and resistive exercise program at a local fitness facility. More positive improvements in cognitive and psychosocial functioning among participants in the CORTEX condition (relative to the Video Attention-Control condition, i.e., health educational videos), are also expected immediately following the cognitive training, and across time. Expectancies and knowledge of study purpose (blinding integrity) will also be measured and used to statistically adjust for any training differences.
Read the detailed description
Primary Aim: To test the effectiveness of a 1-month CT (randomized group condition) on exercise self-regulation, a latent factor representing 12-Month exercise adherence \& program engagement (i.e., supervised \& unsupervised class participation rates, electronically-recorded visitations, Fitbit-derived step counts, \& self-reported leisure-time exercise), the investigators will use a structural equation model with robust maximum likelihood estimation. Exercise self-regulation will be regressed on group and known covariates (age, gender, education level, training compliance [percentage of completed sessions], and injury/illness). It is hypothesized that the CORTEX condition will show increased exercise self-regulation (and lower dropout, a categorical outcome variable, tested in a parallel model) compared to the Video Attention-Control condition.
Secondary Aims: A generalized latent variable framework will be used to test the researchers' theorized model and exploratory questions to determine if the CT contributes to greater cognitive change and enhanced perceptions of memory strategy use, self-efficacy, and self-reported physical activity-specific planning and self-regulatory strategy-use; and in turn, greater exercise self-regulation/ lower dropout. To evaluate these questions, first and second-order latent change scores will be derived representing general \& exercise-specific cognitive functioning (reaction times and accuracy within training domains), self-efficacy and self-reported self-regulatory strategies, and will be added to the latent exercise self-regulation measurement model (and adjusted with known covariates, i.e., group, age, gender, education, compliance, injury/illness). Positive indirect effects of CT condition on 12-month exercise self-regulation are expected through the change in theoretical constructs-dual task and memory performance, implicit attitudes, memory strategy-use, self-efficacy, exercise planning and physical activity-specific self-regulatory strategy-use. Researchers also predict that the CT program will demonstrate high feasibility/acceptability, as indicated by a thorough process evaluation.
- Conditions
- Patient Compliance
- Being tested
- Games, Videos
- Keywords
- adherence, cognition, exercise, aging, brain training, cognitive training, executive function
- Medical subject headings
- Patient Compliance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GamesBehavioural
Also called Gaming Condition
The game training will emphasize general and exercise-specific dual task processing, self-priming and certainty training.
VideosBehavioural
Also called Video Condition
The video training will emphasize health and educational information.
| Study group | Role | What they receive |
|---|---|---|
| Gaming Condition | Experimental | The games group will visit the lab on 5 separate occasions, for 2 hours each, to complete training sessions (playing seated and standing computerized games), and then complete 5 similar sessions at home (lasting 2 hours, but may be split into 1-hour sessions at their convenience), at the onset of the exercise program. The training sessions will be scheduled concurrently with exercise classes in the first month. This group will also be asked to accumulate 150 minutes of exercise by attending weekly supervised and unsupervised, group-based aerobic and resistance exercise classes, by visiting the fitness facility alone, and by walking or strength training at home when necessary to supplement fitness facility activities to fully meet public health recommendations, for a period of 12 months. Receives: Behavioral: Games |
| Video Condition | Active comparator | The videos group will visit the lab on 5 separate occasions, for 2 hours each, to view health and educational YouTube videos, and then view 5 similar sessions at home (lasting 2 hours, but may be split into 1-hour sessions at their convenience), at the onset of the exercise program. The training sessions will be scheduled concurrently with exercise classes in the first month. This group will also be asked to accumulate 150 minutes of exercise by attending weekly supervised and unsupervised, group-based aerobic and resistance exercise classes, by visiting the fitness facility alone, and by walking or strength training at home when necessary to supplement fitness facility activities to fully meet public health recommendations, for a period of 12 months. Receives: Behavioral: Videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise self-regulation
Exercise self-regulation will be modeled within a latent variable framework. The change factor will be reflected by accumulated supervised and unsupervised class participation rates, total electronically-recorded visitations, averaged monthly Fitbit-derived step counts, and self-reported leisure-time exercise (via Godin Leisure-Time Questionnaire). Measures will be standardized as z-scores. The latent factor model will be adjusted for known covariates (age, gender, education level, training compliance [percentage of completed sessions] and injury/illness) when primary hypothesis of group effects is tested. There is always the possibility that attempts to analyze latent constructs will not converge as planned. In such a case, researchers will attempt to assess change across each behavioral outcome individually with a robust linear regression method, adjusting for multiple comparisons.
Measured: 12 months
Secondary outcomes (6)
Dual task functioning (change)
Four separate heterogeneous dual task transfer assessments will involve auditory and/or visual stimuli. The tasks will progress from a focus on response to singularly-presented stimuli to dual task trials involving equally-prioritized responses (accuracy and quickness) to combinations of colors-letters, pictures-arrows, sounds-voices, and animals-planets. The percentage of incorrect response trials, accuracy, and reaction time will be the outcome measures for each of these tasks. Dual-task percent cost will then be calculated by the following equation: (dual task reaction time - single task reaction time) /single reaction time) x 100. Cost scores will be included as latent factor indicators in a structural equation model testing change from baseline to 1-month follow-up (post-intervention). Measures will be standardized as z-scores.
Measured: 1 month
Memory functioning (change)
Again, from a latent factor perspective, multiple measures will be used to assess the construct of memory functioning, which will reflect overall working memory, spatial and episodic memory. Assessments will be utilized from the iPad-delivered NIH Toolbox, as well computerized assessments developed in E-Prime (e.g., Sternberg). Latent factor memory functioning change from baseline to 1-month follow-up (post-intervention) will be represented by total percent correct for each assessment at each time point. Measures will be standardized as z-scores.
Measured: 1 month
Exercise self-efficacy (change)
Once again, from a latent factor perspective, multiple measures will be used to assess confidence that one can successfully walk longer distances (Self-Efficacy for Walking Scale), continue an exercise regimen (Exercise Self-Efficacy Scale), accumulate physical activity into one's life (Lifestyle Self-Efficacy Scale) and overcome barriers (Barriers Self-Efficacy Scale). An Exercise Self-Efficacy latent factor will be derived from equally-weighted latent factor indicators from each of the scales, and will be used to assess change in exercise-related efficacy beliefs from baseline to 1-month follow-up (post-intervention). Measures will be standardized as z-scores.
Measured: 1 month
Physical activity self-regulatory strategy-use (change)
Participants' perceived use of exercise-specific self-regulatory strategies will be assessed with the multi-dimensional 12-item Physical Activity Self-Regulation Scale. Each of the 12 items will serve as the latent factor indicators for baseline and 1-month follow-up (post-intervention).
Measured: 1 month
Exercise planning (change)
The 10-item Exercise Planning and Scheduling Scale will be used to assess change in exercise-specific planning behaviors from baseline to 1-month follow-up (post-intervention).
Measured: 1 month
Memory strategy-use (change)
Again, from a latent factor framework, multiple self-report scales assessing memory strategy-use (subscale of Metamemory Questionnaire), memory self-efficacy (10-item Memory Self-Efficacy Scale), behavioral self-control (13-item Brief Self-Control Scale), affective and cognitive self-control (10-item Volitional Components Inventory) will be used to derive a latent factor to assess change in perceived Memory Strategy-Use from baseline to 1-month follow-up (post-intervention). Measures will be standardized as z-scores.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 Jan 2017
- Primary completion31 May 2020
- Study completion10 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ComplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Sean Mullen, University of Illinois at Urbana-Champaign
- Investigators
- Sean P Mullen, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124667
- Sponsor's protocol ID
- 16447
- Other IDs
- GRANT12053054, 1R01AG052707-01A1
- Acronym
- CORTEX-II
- Status last verified
- Dec 2020
- First submitted
- 6 Apr 2017
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon study completion and after publication of the primary aims and hypotheses, the investigators will provide de-identified data to any interested parties with the provision that they consult with the investigators about the study design, analytical procedures, and to avoid redundancy in future planned analyses or manuscripts. The PI will be given priority and will work closely with other investigators in maximizing ways to leverage the data to address other research questions. Data generated from this project will be made available in multiple formats with codebooks via NCBI's BioProject within 12 months of completing aforementioned priorities. These include demographic information (e.g., age, gender, and education), group assignment codes, and outcome measures. No personally identifying information will be included. Users must also agree to the conditions of use governing access to the public release data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Regulation Training and Exercise (CORTEX)-II With Middle-Aged Adults
- ClinicalTrials.gov ID
- NCT03124667
- Acronym / sponsor ID
- CORTEX-II / 16447
- Conditions
- Patient Compliance
- Keywords
- adherence, cognition, exercise, aging, brain training, cognitive training, executive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this double-blinded, randomized controlled study is to compare CORTEX (Cognitive Regulation Training and Exercise), a multi-faceted, center- and home-delivered- general and exercise-specific-active and traditional computerized cognitive training (CT) program to an attention-control condition involving health and wellness informational videos. More specifically, the cognitive training group will emphasize dual-task abilities, working memory, and visual-spatial processing, as well as self-as-exerciser priming and self-certainty training. It is hypothesized that early intervention cognitive training will enhance use of self-regulatory strategies and self-efficacy and in turn, increase exercise adherence to and engagement in a 12-month aerobic and resistive exercise program at a local fitness facility. More positive improvements in cognitive and psychosocial functioning among participants in the CORTEX condition (relative to the Video Attention-Control condition, i.e., health educational videos), are also expected immediately following the cognitive training, and across time. Expectancies and knowledge of study purpose (blinding integrity) will also be measured and used to statistically adjust for any training differences.
Detailed description
Primary Aim: To test the effectiveness of a 1-month CT (randomized group condition) on exercise self-regulation, a latent factor representing 12-Month exercise adherence \& program engagement (i.e., supervised \& unsupervised class participation rates, electronically-recorded visitations, Fitbit-derived step counts, \& self-reported leisure-time exercise), the investigators will use a structural equation model with robust maximum likelihood estimation. Exercise self-regulation will be regressed on group and known covariates (age, gender, education level, training compliance [percentage of completed sessions], and injury/illness). It is hypothesized that the CORTEX condition will show increased exercise self-regulation (and lower dropout, a categorical outcome variable, tested in a parallel model) compared to the Video Attention-Control condition.
Secondary Aims: A generalized latent variable framework will be used to test the researchers' theorized model and exploratory questions to determine if the CT contributes to greater cognitive change and enhanced perceptions of memory strategy use, self-efficacy, and self-reported physical activity-specific planning and self-regulatory strategy-use; and in turn, greater exercise self-regulation/ lower dropout. To evaluate these questions, first and second-order latent change scores will be derived representing general \& exercise-specific cognitive functioning (reaction times and accuracy within training domains), self-efficacy and self-reported self-regulatory strategies, and will be added to the latent exercise self-regulation measurement model (and adjusted with known covariates, i.e., group, age, gender, education, compliance, injury/illness). Positive indirect effects of CT condition on 12-month exercise self-regulation are expected through the change in theoretical constructs-dual task and memory performance, implicit attitudes, memory strategy-use, self-efficacy, exercise planning and physical activity-specific self-regulatory strategy-use. Researchers also predict that the CT program will demonstrate high feasibility/acceptability, as indicated by a thorough process evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gaming Condition | Experimental | Behavioral: GamesThe games group will visit the lab on 5 separate occasions, for 2 hours each, to complete training sessions (playing seated and standing computerized games), and then complete 5 similar sessions at home (lasting 2 hours, but may be split into 1-hour sessions at their convenience), at the onset of the exercise program. The training sessions will be scheduled concurrently with exercise classes in the first month. This group will also be asked to accumulate 150 minutes of exercise by attending weekly supervised and unsupervised, group-based aerobic and resistance exercise classes, by visiting the fitness facility alone, and by walking or strength training at home when necessary to supplement fitness facility activities to fully meet public health recommendations, for a period of 12 months. |
| Video Condition | Active comparator | Behavioral: VideosThe videos group will visit the lab on 5 separate occasions, for 2 hours each, to view health and educational YouTube videos, and then view 5 similar sessions at home (lasting 2 hours, but may be split into 1-hour sessions at their convenience), at the onset of the exercise program. The training sessions will be scheduled concurrently with exercise classes in the first month. This group will also be asked to accumulate 150 minutes of exercise by attending weekly supervised and unsupervised, group-based aerobic and resistance exercise classes, by visiting the fitness facility alone, and by walking or strength training at home when necessary to supplement fitness facility activities to fully meet public health recommendations, for a period of 12 months. |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Men and women
- Low active for the past 3 months
- 35 to 64 years old
- Do NOT regularly play exergames (e.g., XBox Kinect, Playstation Move, Nintendo Wii)
- Do NOT engage in "brain training" regularly (less than once per week)
Key exclusion criteria (12 listed)
- Previously involved in the first CORTEX trial
- Currently involved in regular weekly cognitive training or another physical activity program or study (e.g., yoga, meditation)
- Too active (as defined by regularly exercise 2 or more days per week for 30+ minutes over the past 3 months)
- Incapable of performing moderately intensive aerobic exercise (must be able to complete basic movements, i.e., walking, jogging, jumping, side-stepping, throwing, kicking, punching, grabbing) without exacerbating a pre-existing condition caused by overuse, surgery, or other chronic condition
- Unable or unwilling to comply to lab and home-based training and physical activity prescription
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GamesAlso: Gaming ConditionThe game training will emphasize general and exercise-specific dual task processing, self-priming and certainty training. | Behavioural | Gaming Condition |
| VideosAlso: Video ConditionThe video training will emphasize health and educational information. | Behavioural | Video Condition |
Primary outcome
Exercise self-regulation
Time frame: 12 months
Exercise self-regulation will be modeled within a latent variable framework. The change factor will be reflected by accumulated supervised and unsupervised class participation rates, total electronically-recorded visitations, averaged monthly Fitbit-derived step counts, and self-reported leisure-time exercise (via Godin Leisure-Time Questionnaire). Measures will be standardized as z-scores. The latent factor model will be adjusted for known covariates (age, gender, education level, training compliance [percentage of completed sessions] and injury/illness) when primary hypothesis of group effects is tested. There is always the possibility that attempts to analyze latent constructs will not converge as planned. In such a case, researchers will attempt to assess change across each behavioral outcome individually with a robust linear regression method, adjusting for multiple comparisons.
6 secondary outcomes
Dual task functioning (change)
Time frame: 1 month
Memory functioning (change)
Time frame: 1 month
Exercise self-efficacy (change)
Time frame: 1 month
Physical activity self-regulatory strategy-use (change)
Time frame: 1 month
Exercise planning (change)
Time frame: 1 month
Memory strategy-use (change)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Individual participant dataSharing planned: Yes. Upon study completion and after publication of the primary aims and hypotheses, the investigators will provide de-identified data to any interested parties with the provision that they consult with the investigators about the study design, analytical procedures, and to avoid redundancy in future planned analyses or manuscripts. The PI will be given priority and will work closely with other investigators in maximizing ways to leverage the data to address other research questions. Data generated from this project will be made available in multiple formats with codebooks via NCBI's BioProject within 12 months of completing aforementioned priorities. These include demographic information (e.g., age, gender, and education), group assignment codes, and outcome measures. No personally identifying information will be included. Users must also agree to the conditions of use governing access to the public release data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean P Mullen, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Games and Videos in people with Patient Compliance, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise self-regulation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.