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Clinical Trials/NCT02379559
NCT02379559
Completed
Not Applicable

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

Georgetown University1 site in 1 country10 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Activity
Sponsor
Georgetown University
Enrollment
10
Locations
1
Primary Endpoint
Waist circumference
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
February 16, 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Waist circumference

Time Frame: 6-months

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

Secondary Outcomes

  • 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)

Study Sites (1)

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