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Exercise Intervention Metabolic Syndrome Prostate Cancer Black Men

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Georgetown University

关键词

抽象

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.

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.

日期

最后验证: 08/31/2014
首次提交: 09/22/2014
提交的预估入学人数: 03/03/2015
首次发布: 03/04/2015
上次提交的更新: 02/16/2017
最近更新发布: 02/22/2017
实际学习开始日期: 06/30/2013
预计主要完成日期: 02/15/2017
预计完成日期: 02/15/2017

状况或疾病

Physical Activity
Metabolic Syndrome
Prostate Cancer

干预/治疗

Behavioral: Exercise Group

Behavioral: Attention Control Group

-

手臂组

干预/治疗
Experimental: Exercise Group
Eligible participants randomized into the intervention group will receive a mix of supervised moderate-intensity aerobic and light weight-resistance exercises.
Behavioral: Exercise Group
For the first 12-weeks, participants will come to our community based research office for up to 50 min/session, 3-days/week of supervised exercise. Exercise duration will increase from 75 min/wk at week 1 to 150 min/wk by week 4. Thereafter, men will maintain 150 min/wk of moderate-intensity physical activity.
Active Comparator: Attention Control Group
Eligible participants randomized in the attention control group will be asked to maintain their current daily activities and exercise habits for 6-months.
Behavioral: Attention Control Group
We will provide weekly healthy lifestyle tips via text messages, and will include tips such as managing stressors in life and getting better sleep.

资格标准

有资格学习的年龄 40 Years 至 40 Years
有资格学习的性别Male
接受健康志愿者
标准

Inclusion Criteria:

1. African-American and/or Black men;

2. between the ages of 40-70 years;

3. waist circumference >40 inches (102 cm);

4. with at least two of the following: elevated BP (≥ 130/85 mmHg);

5. elevated fasting glucose (≥ 100 mg/dL), reduced HDL cholesterol (<50 mg/dL), or elevated triglycerides (≥ 150 mg/dL);

6. sedentary defined as <60 minutes of recreation or work requiring modest PA/week;

7. be able to speak and read English;

8. able to provide meaningful consent (i.e., men with severe cognitive impairment will be excluded);

9. have no physical limitations that prevent from exercising;

10. and have access to a television and DVD player.

Exclusion Criteria:

1. history of cancer except nonmelanoma skin cancer;

2. current enrollment in another clinical trial or weight loss program;

3. 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.

结果

主要结果指标

1. Waist circumference [6-months]

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

次要成果指标

1. Dietary behaviors questionnaire [6-months]

Block 2005 Food Frequency Questionnaires (FFQ) at baseline, 3- and 6-months of the intervention

2. Cardiovascular fitness test [6-months]

Bruce treadmill protocol will be used to determine VO2max at baseline, 3- and 6-months of the intervention.

3. Fasting glucose levels test [6-months]

Fasting blood sample via finger sticks will be administered by a phlebotomist to measure fasting glucose levels at baseline, 3- and 6-months of the intervention.

4. Lipid level test [6-months]

Fasting blood sample via finger sticks will be administered by a phlebotomist to measure lipid levels at baseline, 3- and 6-months of the intervention.

5. Quality of life questionnaire (SF-36) [6-months]

Short Form 36 Health Survey (SF-36) will be administered at baseline, 3- and 6-months of the intervention.

6. Body Mass Index (BMI) [6-months]

Weight (lbs) and height (inches) will be measured to calculate BMI at baseline, 3- and 6-months of the intervention.

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