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Program for African American Cognition & Exercise (PAACE)

23 de junio de 2020 actualizado por: Robert L. Newton, Jr., Pennington Biomedical Research Center
The study is designed to develop and evaluate a physical activity promotion program among elderly African Americans with a long-term goal of reducing risk of Alzheimer's disease. The motivation for this study is that previous exercise interventions have improved cognitive function in older adults with and without cognitive impairments, but these studies were largely conducted without substantial African American representation. Due to genetic and environmental differences between African American and other populations, it is unclear whether positive findings from previous interventions will translate to African American individuals. Investigators hypothesize that a community-based physical activity intervention will a) be tailored to African American adults, b) increase daily amounts of physical activity, and c) improve cognitive function in sedentary older African American adults.

Descripción general del estudio

Estado

Terminado

Condiciones

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

Intervencionista

Inscripción (Actual)

56

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

    • Louisiana
      • Baton Rouge, Louisiana, Estados Unidos, 70808
        • Pennington Biomedical Research Center

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

65 años a 85 años (Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. 65 - 85 years of age
  2. African American
  3. sedentary or insufficiently active
  4. not cognitively impaired
  5. physically capable of exercise
  6. willing to accept randomization
  7. willing to attend group sessions
  8. willing to live in the study area for the next 6 months
  9. willing to allow researchers to use data for research purposes after study participation is completed
  10. free of conditions that would make regular exercise unsafe as deemed by the medical investigator

Exclusion Criteria:

  1. unable or unwilling to give informed consent or accept randomization in either study group
  2. are cognitively impaired (MMSE score of ≤ 26)
  3. are unable to complete physical activity requirements (SPPB ≤ 3, complete 2 minute walk without sitting or resting against a surface)
  4. are too active (steps per day > 50th percentile for age and gender)
  5. have uncontrolled hypertension (systolic blood pressure > 200 mmHg and/or diastolic blood pressure > 110 mmHg).
  6. gave had a hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
  7. 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
  8. are undergoing physical therapy or cardiopulmonary rehabilitation
  9. are currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
  10. have another member of the household that is a participant in PAACE
  11. have plans to relocate out of the study area within the next 6 months
  12. have uncontrolled diabetes that in the judgment of the MI may interfere with study participation
  13. 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

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: 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
Aerobic, strength training, balance, flexibility
Comparador activo: Successful Aging
Those randomized to the successful aging group will receive health information pertinent to African Americans over the 12 weeks
Healthy aging education

¿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
Steps will be measured by the abtigraph WGT3X+ accelerometer.
7-day period

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in dementia screening.
Periodo de tiempo: Week 0 and Week 12
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
Change in cognition.
Periodo de tiempo: Week 0 and Week 12
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.
Week 0 and Week 12
Change in quality of life.
Periodo de tiempo: Week 0 and Week 12
The Health Related Quality of Life questionnaire consists of 27 questions.
Week 0 and Week 12
Change in health care utilization.
Periodo de tiempo: Week 0 and Week 12
The Health Care Utilization questionnaire consists of 12 questions. Participants report utilization of various health care avenues.
Week 0 and Week 12
Change in depressive symptoms.
Periodo de tiempo: Week 0 and Week 12
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).
Week 0 and Week 12
Change in resilience.
Periodo de tiempo: Week 0 and Week 12
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)
Week 0 and Week 12

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
Use focus groups to gather information needed to tailor a physical activity program
1.5 hour focus groups prior to RCT. Recruitment, retention and protocol compliance throughout the intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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 (Actual)

19 de febrero de 2018

Finalización primaria (Actual)

30 de junio de 2019

Finalización del estudio (Actual)

30 de junio de 2019

Fechas de registro del estudio

Enviado por primera vez

15 de marzo de 2018

Primero enviado que cumplió con los criterios de control de calidad

15 de marzo de 2018

Publicado por primera vez (Actual)

22 de marzo de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de junio de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

23 de junio de 2020

Última verificación

1 de junio de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2017-022

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 Physical Activity

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