- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01837004
Cognitive Regulation Training and Exercise (CORTEX)
Cognitive Regulation Training and Exercise (CORTEX) Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Illinois
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Urbana, Illinois, Estados Unidos, 61801
- University of Illinois
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: CORTEX
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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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exercise adherence
Periodo de tiempo: 4 months (from exercise intervention baseline to 4-month post-test)
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4 months (from exercise intervention baseline to 4-month post-test)
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exercise program engagement
Periodo de tiempo: 4 month period (exercise intervention start to end)
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4 month period (exercise intervention start to end)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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automaticity of exercise-related efficacy judgments
Periodo de tiempo: 5-month period
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-reaction times and interference associated with a novel self-efficacy judgment task; collected at baseline, m1, and m5
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5-month period
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exercise-related self-efficacy
Periodo de tiempo: 5-month period
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-self-reported confidence in one's ability to adhere to different aspects of the exercise program; collected at baseline, m1, m2, and m5
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5-month period
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executive functioning
Periodo de tiempo: 5-month period
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-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
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5-month period
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sean P Mullen, Ph.D., University of Illinois at Urbana-Champaign
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 1R21HL11341001A1
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