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临床试验/NCT01102985
NCT01102985已完成不适用

An Exercise Intervention to Improve Health in Postmenopausal Cancer Survivors

Yale University2 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
154
试验地点
2
主要终点
Bone mass-lumbar spine and hip (DEXA)

研究概览

简要总结

The purpose of the study is to evaluate the effect of an aerobic-resistance exercise program compared to a home based physical activity program on bone mass, body composition, metabolic risk factors and cardiovascular fitness in women with cancer who have completed therapy.

详细描述

The proposed study will evaluate an endurance-resistive exercise intervention to attenuate the effects of menopause and cancer treatment (bone loss, increased body fat, decreased lean muscle mass, weight gain, decreased physical activity) in an at-risk population of female cancer survivors. Women with solid tumors (breast, gynecological, colo-rectal) and lymphoma who have completed primary and/or adjuvant therapy within the past three years and who are perimenopausal or early postmenopausal and any woman on an Aromatase Inhibitor will be recruited to participate in a randomized controlled trial (RCT) of a 12 month exercise intervention (N=75) versus a health promotion control group (N=75). The specific aims of the study are to: (1) examine the effects of an exercise intervention on bone mass (serum biomarkers, lumbar spine, hip DEXA) and body composition (whole body DEXA, weight, waist circumference), (2) examine the effect of an exercise intervention on metabolic risk factors (lipids, cholesterol, fasting glucose, insulin resistance, Hemoglobin A1-C, and blood pressure), and (3) examine the effects of an exercise intervention on functional status and cardiovascular fitness (exercise stress test).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Cancer diagnosis
  • Postmenopausal

排除标准

  • Health condition contraindication to moderate physical activity

结局指标

主要结局

Bone mass-lumbar spine and hip (DEXA)

时间窗: baseline, 12 months

Serum biomarkers for bone (serum NTX and serum osteocalcin) will be drawn at baseline, 6 and 12 months. Bone mass for lumbar spine and hip will be measured by DEXA scan at baseline and 12 months.

次要结局

  • body composition-% fat mass, % lean muscle mass (whole body DEXA)(baseline, 6, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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