- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03124667
Cognitive Regulation Training and Exercise Trial (CORTEX-II)
Cognitive Regulation Training and Exercise (CORTEX)-II With Middle-Aged Adults
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Illinois
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Urbana, Illinois, Vereinigte Staaten, 61801
- University of Illinois
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- 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
- 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])
Exclusion Criteria:
- 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
- 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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Gaming Condition
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.
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The game training will emphasize general and exercise-specific dual task processing, self-priming and certainty training.
Andere Namen:
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Aktiver Komparator: Video Condition
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.
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The video training will emphasize health and educational information.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Exercise self-regulation
Zeitfenster: 12 months
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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.
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12 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Dual task functioning (change)
Zeitfenster: 1 month
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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.
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1 month
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Memory functioning (change)
Zeitfenster: 1 month
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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.
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1 month
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Exercise self-efficacy (change)
Zeitfenster: 1 month
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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.
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1 month
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Physical activity self-regulatory strategy-use (change)
Zeitfenster: 1 month
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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).
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1 month
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Exercise planning (change)
Zeitfenster: 1 month
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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).
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1 month
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Memory strategy-use (change)
Zeitfenster: 1 month
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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.
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1 month
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Mitarbeiter und Ermittler
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 16447
- GRANT12053054 (Andere Zuschuss-/Finanzierungsnummer: National Institute on Aging)
- 1R01AG052707-01A1 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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