Exercise Intervention Metabolic Syndrome Prostate Cancer Black Men

Prostate Cancer Clinical Trial

— STRONG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379559
• Other study ID #: Georgetown_University_MC1
• Status: Completed
• Phase: N/A
• First received: September 23, 2014
• Last updated: February 17, 2017
• Start date: July 2013
• Est. completion date: February 16, 2017

Study information

• Verified date: September 2014
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 16, 2017
• Est. primary completion date: February 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Physical Activity
• Prostate Cancer
• Prostatic Neoplasms
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Office of Minority Health and Health Disparities Research	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Waist circumference	Waist circumference will be measured at baseline, 3- and 6-months of the intervention	6-months
Secondary	Dietary behaviors questionnaire	Block 2005 Food Frequency Questionnaires (FFQ) at baseline, 3- and 6-months of the intervention	6-months
Secondary	Cardiovascular fitness test	Bruce treadmill protocol will be used to determine VO2max at baseline, 3- and 6-months of the intervention.	6-months
Secondary	Fasting glucose levels test	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.	6-months
Secondary	Lipid level test	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.	6-months
Secondary	Quality of life questionnaire (SF-36)	Short Form 36 Health Survey (SF-36) will be administered at baseline, 3- and 6-months of the intervention.	6-months
Secondary	Body Mass Index (BMI)	Weight (lbs) and height (inches) will be measured to calculate BMI at baseline, 3- and 6-months of the intervention.	6-months