Exercise Intervention Metabolic Syndrome Prostate Cancer Black Men

Not Applicable

Completed

• Conditions: Physical Activity; Metabolic Syndrome; Prostate Cancer
• Interventions: Behavioral: Attention Control; Behavioral: Exercise

• Registration Number: NCT02379559
• Lead Sponsor: Georgetown University

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.

Study Timeline

• Study Start: 2013-07
• Status Verified: 2014-09
• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-05
• Primary Completion: 2017-02-16
• Study Completion: 2017-02-16
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attention Control Group	Attention Control	Eligible participants randomized in the attention control group will be asked to maintain their current daily activities and exercise habits for 6-months.
Exercise Group	Exercise	Eligible participants randomized into the intervention group will receive a mix of supervised moderate-intensity aerobic and light weight-resistance exercises.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cardiovascular fitness test	6-months	Bruce treadmill protocol will be used to determine VO2max at baseline, 3- and 6-months of the intervention.
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.
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.
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.
Dietary behaviors questionnaire	6-months	Block 2005 Food Frequency Questionnaires (FFQ) at baseline, 3- and 6-months of the intervention
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.

Trial Locations

Locations (1)

Office of Minority Health and Health Disparities Research; 🇺🇸 Washington, District of Columbia, United States