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Completed

NCT Number: NCT02379559

Exercise Intervention Metabolic Syndrome Prostate Cancer Black Men

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.

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Key information

Age range

40 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Office of Minority Health and Health Disparities Research

Washington D.C., District of Columbia, 20003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

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.

Attention Control

Behavioral

We will provide weekly healthy lifestyle tips via text messages, and will include tips such as managing stressors in life and getting better sleep.

Primary outcomes

  1. Waist circumference

    Time frame: 6-months

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

Secondary outcomes

  1. Dietary behaviors questionnaire

    Time frame: 6-months

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

  2. Cardiovascular fitness test

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 6-months

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

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Registry information

Official study title

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

Acronym: STRONG

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 5, 2015
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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