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Life 2: Improving Fitness and Function in Elders (Project LIFE)

8 de enero de 2015 actualizado por: US Department of Veterans Affairs
The purpose of this study is to determine whether a 12-month physical activity counseling program, compared to usual care, improves physical performance in a sample of older veterans. The primary physical performance outcome is change in gait speed.

Descripción general del estudio

Descripción detallada

Physical inactivity contributes greatly to the health care burden of older adults and is associated with a high prevalence of functional limitations, morbidity, and disability. Rates of physical inactivity are highest among older adults. Older veterans, compared non-veteran older adults, are more likely to be physically inactive and report more limitations in physical function. Increasing physical activity among older veterans is a promising approach to reduce the burden of chronic disease and its associated functional limitations. The purpose of this study is to determine whether a 12-month physical activity counseling program, compared to usual care, improves physical performance in a sample of older veterans The primary physical performance outcome is change in gait speed. Secondary objectives include examination of the effect of intervention between the two groups (intervention and usual care) on physical activity, self-reported physical function, and health-related quality of life. We also will estimate health care costs between the two groups to determine the short-term economic impact of the counseling in the VHA. Design. Randomized controlled clinical trial. Data collection. All consented patients will receive a baseline computer assisted interview and physical performance test to be repeated quarterly for one-year. The primary outcome is change in gait speed, which is highly predictive of subsequent institutionalization and mortality. Secondary outcome measures include: the SF-36 physical function and other relevant subscales, health-related quality of life, physical activity, self-efficacy, and personal functional goals. Differences between groups for non-routine outpatient clinic use and hospitalization will be explored. The cost of providing an intensive intervention (relative to the cost of usual care) will be calculated relative to functional changes between groups. Individuals randomized to the intervention group will receive a physical activity counseling intervention that includes four components. We will measure and assess change at each endpoint (3,6,9, 12, and 24 months) to determine short and long-term efficacy. Secondary analyses will include: (a) effect of intervention on self-reported physical function, physical activity, personal functional goals, and self-efficacy, and (b) comparison of outpatient clinic use and hospitalization costs between treatment arms relative to intervention costs. Duration Four years. Relevance to the VA. Because approximately 50% of veterans over age 74 have a limiting disability, it is imperative to explore strategies that will alter the course of functional decline of our aging veterans.

Tipo de estudio

Intervencionista

Inscripción (Actual)

400

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

    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27705
        • VA Medical 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

70 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age 70 or over
  • Followed in VA primary care or geriatrics clinic
  • Currently not regularly physically active
  • Able to walk 10 meters without human assistance (assistive device acceptable)

Exclusion Criteria:

  • Age 70 or over
  • Followed in VA primary care or geriatrics clinic
  • Currently not regularly physically active
  • Able to walk 10 meters without human assistance (assistive device acceptable)
  • A terminal diagnosis

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: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Brazo 2
Cuidado usual
Experimental: Arm 1
Behavioral: Multi-component physical activity counseling program A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Usual Gait Speed
Periodo de tiempo: Baseline
Best of two trials over 8-foot walk
Baseline
Usual Gait Speed
Periodo de tiempo: 3 month
3 month
Usual Gait Speed
Periodo de tiempo: 12-month
12-month
Rapid Gait Speed
Periodo de tiempo: Baseline
Baseline
Rapid Gait Speed
Periodo de tiempo: 3-month
3-month
Rapid Gait Speed
Periodo de tiempo: 12-month
12-month

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Physical Activity Frequency (CHAMPS Questionnaire)
Periodo de tiempo: Baseline
Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities
Baseline
Physical Activity Frequency (CHAMPS Questionnaire)
Periodo de tiempo: 3 month
Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities
3 month
Physical Activity Frequency (CHAMPS Questionnaire)
Periodo de tiempo: 12 month
Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities
12 month
Self Rated Health
Periodo de tiempo: Baseline
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
Baseline
Self Rated Health
Periodo de tiempo: 3 month
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
3 month
Self Rated Health
Periodo de tiempo: 12 month
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
12 month
Sf-36 Physical Function Subscale
Periodo de tiempo: Baseline
This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.
Baseline
Sf-36 Physical Function Subscale
Periodo de tiempo: 3 month
This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.
3 month
Sf-36 Physical Function Subscale
Periodo de tiempo: 12 month
This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.
12 month
2 Minute Walk
Periodo de tiempo: Baseline
Distance walked in two minutes in meters
Baseline
2 Minute Walk
Periodo de tiempo: 3 month
Distance walked in two minutes in meters
3 month
2 Minute Walk
Periodo de tiempo: 12 month
Distance walked in two minutes in meters
12 month

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Miriam C. Morey, PhD, VA Medical Center

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.

Publicaciones Generales

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 noviembre de 2004

Finalización primaria (Actual)

1 de abril de 2008

Finalización del estudio (Actual)

1 de abril de 2008

Fechas de registro del estudio

Enviado por primera vez

12 de febrero de 2007

Primero enviado que cumplió con los criterios de control de calidad

13 de febrero de 2007

Publicado por primera vez (Estimar)

14 de febrero de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

9 de enero de 2015

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

8 de enero de 2015

Última verificación

1 de enero de 2015

Más información

Términos relacionados con este estudio

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