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临床试验/NCT02379559
NCT02379559已完成不适用

An Exercise Intervention on Metabolic Syndrome and Prostate Cancer Risk Among Black Men

Georgetown University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年7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
10
试验地点
2
主要终点
Waist circumference

研究概览

简要总结

The main purpose of this study is to examine the feasibility of an exercise intervention on metabolic syndrome (MetS) components and biomarkers related to prostate cancer in Black men with MetS who are at increased risk of prostate cancer.

详细描述

The specific aim for the proposed study is to examine the feasibility and impact of a 6-month two-arm randomized controlled trial (RCT) on MetS components and biomarkers related to prostate cancer in Black men with MetS. Due to the striking racial disparities of prostate cancer, this proposal will focus on the impact of an aerobic and resistance exercise intervention on MetS and biomarkers related to prostate cancer in Black men. Specifically, our proposed clinical trial compares an aerobic and resistance exercise intervention to an attention control group among Black men.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • African-American and/or Black men;
  • between the ages of 40-70 years;
  • waist circumference >40 inches (102 cm);
  • with at least two of the following: elevated BP (≥ 130/85 mmHg);
  • elevated fasting glucose (≥ 100 mg/dL), reduced HDL cholesterol (<50 mg/dL), or elevated triglycerides (≥ 150 mg/dL);
  • sedentary defined as <60 minutes of recreation or work requiring modest PA/week;
  • be able to speak and read English;
  • able to provide meaningful consent (i.e., men with severe cognitive impairment will be excluded);
  • have no physical limitations that prevent from exercising;
  • and have access to a television and DVD player.

排除标准

  • history of cancer except nonmelanoma skin cancer;
  • current enrollment in another clinical trial or weight loss program;
  • inability to commit to the intervention schedule. Prior to randomization, participants will be required to have a signed authorization and medical clearance from their personal physician or our nurse practitioner.

结局指标

主要结局

Waist circumference

时间窗: 6-months

Waist circumference will be measured at baseline, 3- and 6-months of the intervention

次要结局

  • Cardiovascular fitness test(6-months)
  • Fasting glucose levels test(6-months)
  • Body Mass Index (BMI)(6-months)
  • Lipid level test(6-months)
  • Dietary behaviors questionnaire(6-months)
  • Quality of life questionnaire (SF-36)(6-months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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