Effects of an Interdisciplinary Fitness and Social Engagement Intervention (InFuSe)
31 de agosto de 2018 actualizado por: Washington D.C. Veterans Affairs Medical Center
Effects of an Interdisciplinary Fitness and Social Engagement Intervention on Physical Activity, Sleep Quality and Community Integration
This study will evaluate feasibility and preliminary effectiveness of a 10-week interdisciplinary and multimodal intervention that utilizes patient education, group discussion, and supervised exercise for Veterans with a history of traumatic brain injury (TBI).
Primary outcomes include physical activity (PA), sleep quality, and community integration.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
This randomized controlled trial will have a sample size of 24.
Veterans between the ages of 18 and 65 in the Polytrauma and TBI program who are greater than 1 year post injury prior to entering the study, will be recruited.
After randomization participants in the intervention group will complete a 10 week bout of multidisciplinary wellness education, group discussion, and supervised exercise.
The intervention will occur weekly and last up to 2 hours.
The control group will complete a 10week comprehensive health education program simultaneously.
All measures will be collected again, post intervention.
A follow-up collection will occur at 3 months post-intervention.
Tipo de estudio
Intervencionista
Inscripción (Actual)
24
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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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20422
- Washington DC VA medical Center
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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:
- TBI of at least mild severity using criteria related to disturbance of consciousness
- Most recent TBI occurred >1 year prior to consent process
- Medically stable with physician approval to participate
Exclusion Criteria:
- Unable to provide informed consent and no proxy available
- Prior history of known bipolar disorder or schizophrenia or severe psychiatric illness
- Veterans with any cardiac condition that may cause sudden decompensation during cardiovascular testing and training (e.g., severe congestive heart failure and uncontrolled hypertension)
- Veteran is currently active in a skilled physical therapy program.
- Veterans who meet or exceed American Heart Association and American College of Sports Medicine guidelines for physical activity
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: InFuSE
Experimental group which will receive health education, group discussion, and supervised exercise.
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Each session includes a 45-minute education and group discussion.
A 60-minute exercise component then completes the session.
Each topic was specifically picked and tailored to benefit Veterans with TBI.
The education sessions will be led and moderated by different professionals including physical therapists, recreation therapists, and physicians.
Participants will be asked to participate in several learning activities.
The activities are included to help improve understanding and promote group discussion.
The exercise piece consists of a warm-up, endurance training (20-30 minutes), strengthening (15 minutes), balance/cognitive training (15 minutes), and a cool-down.
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Comparador activo: Patient Education/Group Discussion
Active control group which will receive health education and group discussion.
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Each week you will participate in a 1 hour health education class with other Veterans.
Each topic was specifically picked and tailored for Veterans with TBI.
These education sessions will be led and moderated by different professionals including physical therapists, recreation therapists, and physicians.
Participants will be asked to participate in several learning activities which are included to help improve understanding and promote group discussion.
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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 Self-Efficacy Scale (ESES)
Periodo de tiempo: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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ESES measures an individual's perceived ability to overcome various obstacles to perform physical activity.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Sleep Efficiency
Periodo de tiempo: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Sleep efficiency is the total number of minutes of sleep divided by the number of minutes spent in bed.
Sleep efficiency is measured by polysomnography.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Functional Capacity
Periodo de tiempo: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Functional capacity is evaluated using a Bruce protocol treadmill maximal exertion stress test.
The maximum amount of work performed by the participant on the treadmill is measured as metabolic equivalents (METs)
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Dynamic Gait Index (DGI)
Periodo de tiempo: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A common clinical measure used to evaluate dynamic balance and coordination during a person's daily activities.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A self-reported measure to evaluate and monitor overall sleep quality.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Mayo Portland Adaptability Index (MPAI-4)
Periodo de tiempo: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A measure of self-reported quality of life, limitation severity, and community participation after TBI.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Community Reintegration of Service Members (CRIS)
Periodo de tiempo: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A self-reported measure of the ability of service members to reintegrate after returning to civilian life.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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California Verbal Learning Test-Second Edition (CVLT-II)
Periodo de tiempo: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A widely used measure of verbal learning and memory using a multiple-trial list-learning task.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Brief Symptoms Inventory 18 (BSI-18)
Periodo de tiempo: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A self-report measure of depression, anxiety, somatic concerns, and general distress.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Post-Traumatic Stress Disorder Checklist (PCL)
Periodo de tiempo: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A measure of the severity of PTSD related symptoms including intrusive thoughts, avoidance behavior, and arousal.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
1 de junio de 2016
Finalización primaria (Anticipado)
1 de diciembre de 2018
Finalización del estudio (Anticipado)
1 de diciembre de 2018
Fechas de registro del estudio
Enviado por primera vez
28 de marzo de 2017
Primero enviado que cumplió con los criterios de control de calidad
17 de mayo de 2017
Publicado por primera vez (Actual)
19 de mayo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de septiembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
31 de agosto de 2018
Última verificación
1 de agosto de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 01798
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .
Ensayos clínicos sobre InFuSE
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Gruppo Italiano per lo studio dei Carcinomi dell...Mario Negri Institute for Pharmacological ResearchDesconocido