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The Effect of Exercise Intervention on the Community's Older Adults

11 de mayo de 2018 actualizado por: Robert Wen-Wei Hsu, Chang Gung Memorial Hospital

The Effect of Exercise Intervention on the Physical Fitness, Bone Mineral Density and Health-related Quality of Life in the Community's Older Adults

Osteoporosis is a serious global health problem, second only to cardiovascular disease. Osteoporosis is the most common metabolic bone disease in the elderly population, characterized by loss of bone mineral density (BMD) and continuous destruction of bone microstructure, especially in postmenopausal women. It gives rise to bone fragility and fracture risk. Moreover, as people grow older, falls frequently occur with high severity, and nearly 35% to 45% of persons aged 65 or older fall at least once a year. Osteoporotic fractures increase mortality, morbidity, chronic pain, and the cost of social care and it decreases the quality of life. Here, investigators plan to perform different exercise interventions such as circuit exercise, aerobic dance and Tai Chi on the community's older adults to evaluate whether exercise intervention could improve the bone mineral density, physical fitness, muscle strength or quality of life.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

411

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

      • Pizi, Taiwán, 613
        • Sports Medicine Center, Chang Gung Memorial Hospital

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

45 años a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Being >45 years-of-age,
  • Healthy and physically independent.

Exclusion Criteria:

  • The exclusion criteria were individuals on hormone replacement therapy and those with cognitive impairment, progressive debilitating conditions, bone fractures, or any medical contraindications to administering the fitness assessment.

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: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Control
without exercise intervention
Experimental: Exercise
Subjects with circuit exercise, aerobic dance, or Tai Chi exercise intervention.
circuit exercise, aerobic dance and Tai Chi exercise

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline bone mineral density
Periodo de tiempo: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Bone mineral density measurement is measured by dual-energy x-ray absorptiometry (DXA). Measurements are made over the lumbar spine and over the upper part of the hip and the measurement is assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline elbow muscle strength
Periodo de tiempo: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Extension and flexion of elbow were tested by the HUMAC NORM system (CSMi, Stoughton, MA) with the eccentric/concentric contraction mode at an angular velocity of 60 degrees/s.Isokinetic tests were performed five times for each participant, and each test was separated by a rest period of 3 min.The Muscle strength was present as a peak torque which was normalized to body weight (Unit:Nm/kg). The participants are assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Change from baseline shoulder muscle strength
Periodo de tiempo: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Extension and flexion of shoulder were tested by the HUMAC NORM system (CSMi, Stoughton, MA) with the eccentric/concentric contraction mode at an angular velocity of 60 degrees/s.Isokinetic tests were performed five times for each participant, and each test was separated by a rest period of 3 min.The Muscle strength was present as a peak torque which was normalized to body weight (Unit:Nm/kg). The participants are assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Change from baseline hip muscle strength
Periodo de tiempo: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Extension and flexion of hip were tested by the HUMAC NORM system (CSMi, Stoughton, MA) with the eccentric/concentric contraction mode at an angular velocity of 60 degrees/s.Isokinetic tests were performed five times for each participant, and each test was separated by a rest period of 3 min.The Muscle strength was present as a peak torque which was normalized to body weight (Unit:Nm/kg). The participants are assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Change from baseline knee muscle strength
Periodo de tiempo: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Extension and flexion of knee were tested by the HUMAC NORM system (CSMi, Stoughton, MA) with the eccentric/concentric contraction mode at an angular velocity of 60 degrees/s.Isokinetic tests were performed five times for each participant, and each test was separated by a rest period of 3 min.The Muscle strength was present as a peak torque which was normalized to body weight (Unit:Nm/kg). The participants are assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Change from baseline SF-36 questionnaire assessment
Periodo de tiempo: Pre-intervention, 3-month, 6-month, 9-month-follow-up
SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower score the more disability. The higher the score the less disability. Eight sections including physical function, role limitation due to physical problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health. Additionally, the eight health domains can be used to provide a physical component summary and mental component summary score. The outcome measurement is assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
High-density lipoprotein from blood sample
Periodo de tiempo: Pre-intervention, 3-month, 6-month, 9-month-follow-up
High-density lipoprotein are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Triglyceride from blood sample
Periodo de tiempo: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Triglyceride are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Fasting blood glucose from blood sample
Periodo de tiempo: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Fasting blood glucose are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Blood pressure
Periodo de tiempo: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Diastolic and systolic blood pressure are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Weight parameters of the subjects
Periodo de tiempo: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Weight (kg) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Height parameters of the subjects
Periodo de tiempo: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Height (cm) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Waistline parameters of the subjects
Periodo de tiempo: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Waistline (cm) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Robert Wen-Wei HSU, MD, Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi

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 noviembre de 2009

Finalización primaria (Actual)

1 de diciembre de 2013

Finalización del estudio (Actual)

1 de diciembre de 2013

Fechas de registro del estudio

Enviado por primera vez

13 de octubre de 2016

Primero enviado que cumplió con los criterios de control de calidad

14 de octubre de 2016

Publicado por primera vez (Estimar)

18 de octubre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de mayo de 2018

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

11 de mayo de 2018

Última verificación

1 de mayo de 2018

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CMRPG690111-3;CMRPG6A0421-22

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

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. .

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