Exercise and Cognitive Training
31 de mayo de 2018 actualizado por: Susan Mcgurk, Boston University Charles River Campus
The purpose of this study is to evaluate the potential benefits of combining cognitive remediation and exercise in improving cognitive functioning and response to psychiatric rehabilitation.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Impaired cognitive functioning is a common feature of schizophrenia and other serious mental illnesses that is related to poorer psychosocial functioning and less benefit from psychiatric rehabilitation.
Research shows that cognitive remediation for persons with serious mental illness improves cognitive functioning and response to psychiatric rehabilitation.
There is also evidence that physical activity such as aerobic exercise confers a benefit to cognitive functioning in both clinical and general population samples.
The cognitive benefit of exercise is hypothesized to be the result of enhanced brain-derived neurotrophic factor (BDNF; a protein that promotes plasticity, reduces degeneration, and stimulates nerve cell survival).
However, the potential synergistic effects of cognitive remediation and exercise on cognitive functioning have not been investigated in persons with serious mental illness.
This pilot randomized controlled trial will evaluate the impact of adding a peer run exercise program to a standardized cognitive remediation program on cognitive functioning in 30 people with schizophrenia, schizoaffective disorder or bipolar disorder.
All study participants will receive a 10-week cognitive remediation program shown in previous research to improve cognitive functioning.
One-half (N = 15) of the participants will also receive a peer-led exercise program designed to promote cardiovascular fitness.
The primary research questions addressed are: 1) Does the addition of the exercise program to cognitive remediation lead to greater improvements in cognitive functioning than cognitive remediation alone?, and, 2) Are improvements in cognitive functioning mediated (explained) by exercise-induced increases in BDNF?
The results of this pilot study will inform the design of a larger, more definitive trial to evaluate the potential benefits of combining cognitive remediation and exercise in improving cognitive functioning and response to psychiatric rehabilitation.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Boston University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- a DSM-5 diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder based on the Structured Diagnostic Interview for DSM-5;
- no changes in prescribed psychotropic medication dosage or type for at least 1 month;
- medical clearance from a physician to participate in the exercise program;
- currently exhibiting a sedentary lifestyle, as defined by exercising less than 3 days/wk for at least 20 minutes each time;
- no current active suicidal ideation; and 6) fluent in English.
Exclusion Criteria:
- positive screen for a major neurocognitive disorder (as indicated by a score below 23 on the Folstein Mini Mental Exam or a positive score on the HELPS Brain Injury Screening using only cognitive items for "P" items);
- DSM-5 diagnosis of substance use disorder other than nicotine or caffeine in the last 6 months, or bulimia within the last 6 months;
- body mass index greater than 45; a BMI of 45 was selected as the upper limit in order to screen out individuals with Class III obesity who might be more prone to musculoskeletal injuries than individuals with a BMI at or less than 45; and
- for women, currently pregnant, plans to be pregnant in the next year, or currently breastfeeding.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Exercise and Cognitive Remediation
The exercise intervention is a 10-week program involving 40 minutes of aerobic exercise targeting 60-75% of maximum heart rate on 3 days each week, with an additional 5-minute stretching warm up and cool down.
The experimental group will participate in the exercise intervention as well as cognitive remediation.
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The exercise intervention is a 10-week program involving 40 minutes of aerobic exercise targeting 60-75% of maximum heart rate on 3 days each week, with an additional 5-minute stretching warm up and cool down.
Participants will be engaged in 30 hours of computer-based cognitive exercises with a standardized, widely used software package (Cogpack, Version 7.0, Marker Software), shown to improve cognitive functioning in multiple studies.
One-hour sessions will be conducted 3 times per week for 10 weeks.
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Comparador activo: Cognitive Remediation Only
Participants will be engaged in 30 hours of computer-based cognitive exercises with a standardized, widely used software package (Cogpack, Version 7.0, Marker Software), shown to improve cognitive functioning in multiple studies.
One-hour sessions will be conducted 3 times per week for 10 weeks.
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Participants will be engaged in 30 hours of computer-based cognitive exercises with a standardized, widely used software package (Cogpack, Version 7.0, Marker Software), shown to improve cognitive functioning in multiple studies.
One-hour sessions will be conducted 3 times per week for 10 weeks.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Composite Measure of Change in Neurocognitive functioning
Periodo de tiempo: post- 10 week intervention and 2 weeks after end of intervention
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The neurocognitive outcome variables will be assessed at baseline, the week following the 10-week program, and 2 weeks later.
Neurocognitive tests for primary outcome variables are from the MATRICS Neurocognition Committee for use with people with schizophrenia.
These include tests of 1) attention and vigilance, 2) verbal working memory, 3) verbal learning, 4) visual learning, and 5) information processing speed.
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post- 10 week intervention and 2 weeks after end of intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Susan McGurk, PhD, Boston University
- Investigador principal: Michael Otto, PhD, Boston University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2015
Finalización primaria (Actual)
1 de noviembre de 2017
Finalización del estudio (Actual)
1 de noviembre de 2017
Fechas de registro del estudio
Enviado por primera vez
18 de diciembre de 2014
Primero enviado que cumplió con los criterios de control de calidad
22 de diciembre de 2014
Publicado por primera vez (Estimar)
29 de diciembre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
31 de mayo de 2018
Última verificación
1 de mayo de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 3636
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .