Clinical trial NCT02379559: Exercise Intervention Metabolic Syndrome Prostate Cancer Black Men
Official title: An Exercise Intervention on Metabolic Syndrome and Prostate Cancer Risk Among Black Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Metabolic Syndrome
Prostate Cancer
Keywords: prostate cancer
African-American
Metabolic Syndrome
Exercise
Men's Health
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 10
Sex: MALE
Minimum age (years): 40
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Waist circumference
timeFrame: 6-months
Secondary outcomes:
measure: Dietary behaviors questionnaire
timeFrame: 6-months
measure: Cardiovascular fitness test
timeFrame: 6-months
measure: Fasting glucose levels test
timeFrame: 6-months
measure: Lipid level test
timeFrame: 6-months
measure: Quality of life questionnaire (SF-36)
timeFrame: 6-months
measure: Body Mass Index (BMI)
timeFrame: 6-months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Office of Minority Health and Health Disparities Research
state: District of Columbia
Study officials:
References: