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Bone Estrogen Strength Training (BEST)

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Hormone replacement therapy

+ Strength training

MedicamentoProcedimiento
Quiénes están siendo reclutados

Enfermedades de los Huesos+3

+ Enfermedades Óseas Metabólicas

+ Enfermedades metabólicas

De 40 a 65 años
+11 Criterios de eligibilidad
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Cómo está diseñado el estudio

Estudio de Prevención

Fase 2
Intervencional
Inicio del estudio: agosto de 1995
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity of Arizona
Última actualización: 20 de mayo de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de agosto de 1995

Fecha en la que se inscribió al primer participante.

Osteoporotic fractures associated with low bone mineral density (BMD) are a significant public health problem for women, resulting in over 1 million fractures per year. The increasing incidence of fractures will make an already major health problem an even greater one in the future. Estimates of medical costs for the treatment of osteoporotic fractures are expected to increase from $14.8 billion in 1995 to $60 billion by 2020. Although the Women's Health Initiative is investigating dietary and hormonal factors in relation to bone density, it is not investigating the effects of exercise on reducing bone mineral loss in postmenopausal women. This study includes completion of a large, partially randomized clinical trial evaluating the effect of a 1-year exercise intervention on total body and regional BMD in two populations (hormone replacement therapy [HRT] versus no HRT) of postmenopausal women with a previous history of physical inactivity. A major hypothesis is that, compared to the no-exercise group, the exercise intervention will be an effective alternative to reduce the risk of osteoporosis and the exercise effects will be larger in the cohort of women on HRT than those not on HRT. The exercise program includes progressive resistance exercises using free weights and weight resistance machines and weight-bearing aerobic exercises. We carefully supervise and monitor the exercise compliance by keeping records of the amount of exercise completed at each of three weekly exercise sessions and by measuring strength gains of selected muscle groups. We will measure biochemical markers of bone formation and resorption and hormonal correlates of bone mineral density changes including sex steroids at baseline, 6 months, and 1 year. We have obtained duplicate blood collections, made one week apart, for all cohorts at each of the three measurement periods. We have also collected duplicate dual energy x-ray absorptiometry (DXA) scans at each time period to follow changes in axial and appendicular BMD and total and regional soft tissue body composition as a result of the intervention. We collected extensive dietary intake records during the first year of intervention; we will monitor dietary intake in a 2-year followup using food frequency questionnaires. We will also measure followup BMD, soft tissue, and lean and fat body composition for 2 years in all women who complete the first-year intervention program. Two-hundred sixty-six women have completed the first year of the intervention. The study has a retention rate of 92 percent in the first year for the first four cohorts. Because of the paucity of information regarding long-term effects of exercise, and because of the increased emphasis in the scientific community on evaluating the long-term efficacy of exercise interventions for osteoporosis prevention, this comprehensive 1-year clinical trial and 2-year followup will make an important contribution to determining the future role of combining progressive resistance and weight bearing aerobic exercise in the prevention of osteoporosis in two populations (HRT vs. no HRT) of postmenopausal women.

NCT00000399
Patrocinador PrincipalUniversity of Arizona
Última actualización: 20 de mayo de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 300 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Prevención

Los estudios de prevención buscan evitar que se desarrolle una enfermedad. A menudo incluyen a personas en riesgo y evalúan vacunas, cambios en el estilo de vida o medicamentos preventivos.


Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Mujer

Sexo biológico de los participantes elegibles para inscribirse.

De 40 a 65 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades de los HuesosEnfermedades Óseas MetabólicasEnfermedades metabólicasEnfermedades del sistema musculoesqueléticoEnfermedades Nutricionales y MetabólicasOsteoporosis

Criterios

6 criterios de inclusión requeridos para participar
Age 40-65 years

Cancer free for the last 5 years (treatment free for last 5 years) excluding skin cancers

Nonsmoker

Post-menopausal females, 3-10 years past menopause (natural or surgical menopause); if subjects are currently taking hormone replacement therapy (HRT), they must be taking HRT for at least 1 year but no more than 6 years. The subjects must be relatively sedentary, not currently engaged in strength-training exercises

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5 criterios de exclusión impiden participar
Amount of physical activity exceeds 120 minutes of moderate exercise per week. Moderate exercise examples: brisk walking, golfing, gardening, housework, house painting. Potential subject cannot be weight lifting

Currently participating in any other research study

Currently taking beta-blockers or steroids in large quantities/frequencies

Currently taking medications that control cholesterol or alter bone mineral density

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Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Ina Gittings Bldg. Body Composition Laboratory

Tucson, United StatesAbrir Ina Gittings Bldg. Body Composition Laboratory en Google Maps
Completado1 Centros de Estudio