- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03474302
Program for African American Cognition & Exercise (PAACE)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Investigators will randomize 56 older African American adults into 1) a physical activity intervention specifically tailored to older African American or 2) a successful aging group. The 12-week physical activity intervention will consist of group based exercise sessions at a community facility and the successful aging groups will occur at Pennington Biomedical. Cognitive functioning and blood markers of circulating neurotrophic factors will be assessed to determine the brain effects of physical activity in this understudied population.
Specific Aim 1: To tailor a physical activity promotion intervention to community-dwelling African American elderly adults. Investigators will use focus groups to gather information needed to tailor a physical activity program to elderly African Americans.
Specific Aim 2: To determine if a physical activity promotion intervention in African American adults is effective in modifying physical activity and biological markers.
Specific Aim 3: To determine if a physical activity promotion intervention in African American adults benefits cognition and brain health. Change over the course of the intervention will be assessed in key AD related cognitive domains (memory, executive function, and processing speed).
Collecting this data sets the stage for the definitive study of exercise benefits on measures of amyloid, tau, inflammation, brain metabolism, and other AD-relevant pathways in elderly African Americans, which could in turn increase understanding of neurobiological mechanisms and optimal physical activity recommendations for elderly African Americans.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70808
- Pennington Biomedical Research Center
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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:
- 65 - 85 years of age
- African American
- sedentary or insufficiently active
- not cognitively impaired
- physically capable of exercise
- willing to accept randomization
- willing to attend group sessions
- willing to live in the study area for the next 6 months
- willing to allow researchers to use data for research purposes after study participation is completed
- free of conditions that would make regular exercise unsafe as deemed by the medical investigator
Exclusion Criteria:
- unable or unwilling to give informed consent or accept randomization in either study group
- are cognitively impaired (MMSE score of ≤ 26)
- are unable to complete physical activity requirements (SPPB ≤ 3, complete 2 minute walk without sitting or resting against a surface)
- are too active (steps per day > 50th percentile for age and gender)
- have uncontrolled hypertension (systolic blood pressure > 200 mmHg and/or diastolic blood pressure > 110 mmHg).
- gave had a hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
- have had a myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis or pulmonary embolus in the past 6 months
- are undergoing physical therapy or cardiopulmonary rehabilitation
- are currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
- have another member of the household that is a participant in PAACE
- have plans to relocate out of the study area within the next 6 months
- have uncontrolled diabetes that in the judgment of the MI may interfere with study participation
- have other medical, psychiatric, or behavioral factors that in the judgment of the Principal or Medical Investigator may interfere with study participation or the ability to follow the intervention protocol
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Physical Activity
The intervention will be a 12-week community-based physical activity promotion program
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Aerobic, strength training, balance, flexibility
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Comparador activo: Successful Aging
Those randomized to the successful aging group will receive health information pertinent to African Americans over the 12 weeks
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Healthy aging education
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in steps.
Periodo de tiempo: 7-day period
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Steps will be measured by the abtigraph WGT3X+ accelerometer.
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7-day period
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in dementia screening.
Periodo de tiempo: Week 0 and Week 12
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The Mini-Mental State Examination (MMSE) is a 30-item measure of cognitive function.
Scores range from 0-30, higher scores represent better global cognitive functioning.
|
Week 0 and Week 12
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Change in cognition.
Periodo de tiempo: Week 0 and Week 12
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The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a brief, individually administered battery to measure cognitive decline or improvement.
Four subtests of the full battery of 12 subtests used to assess immediate memory (List Learning and Story Memory), as well as language capacities (i.e., Picture Naming and Semantic Fluency).
T-scores are derived, higher scores represent better functioning.
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Week 0 and Week 12
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Change in quality of life.
Periodo de tiempo: Week 0 and Week 12
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The Health Related Quality of Life questionnaire consists of 27 questions.
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Week 0 and Week 12
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Change in health care utilization.
Periodo de tiempo: Week 0 and Week 12
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The Health Care Utilization questionnaire consists of 12 questions.
Participants report utilization of various health care avenues.
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Week 0 and Week 12
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Change in depressive symptoms.
Periodo de tiempo: Week 0 and Week 12
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The Geriatric Depression Scale (GDS) measures depressive symptoms specifically in an elderly population.
Total scores range from 0 (no depressive symptoms) to 15 (indicative of depression).
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Week 0 and Week 12
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Change in resilience.
Periodo de tiempo: Week 0 and Week 12
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The 25-item Connor-Davidson Resilience Scale (CD-RISC 25) collects information on resilience, which is the ability to thrive despite adversity.
The total score ranges from 0 (low resilience) to 100 (higher resilience)
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Week 0 and Week 12
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Tailored physical activity program for elderly African American adults
Periodo de tiempo: 1.5 hour focus groups prior to RCT. Recruitment, retention and protocol compliance throughout the intervention
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Use focus groups to gather information needed to tailor a physical activity program
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1.5 hour focus groups prior to RCT. Recruitment, retention and protocol compliance throughout the intervention
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Gwizdala KL, Brouillete R, Beyl R, Johnson W, Hebert C, Carter L, Harris M, Newton RL Jr, Carmichael OT. Exercise Effects on Cognition in Older African Americans: A Pilot Randomized Trial. Front Aging Neurosci. 2022 Jul 22;14:921978. doi: 10.3389/fnagi.2022.921978. eCollection 2022.
- Newton RL Jr, Beyl R, Hebert C, Harris M, Carter L, Gahan W, Carmichael O. A Physical Activity Intervention in Older African Americans: The PAACE Pilot Randomized Controlled Trial. Med Sci Sports Exerc. 2022 Oct 1;54(10):1625-1634. doi: 10.1249/MSS.0000000000002956. Epub 2022 May 7.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- 2017-022
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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