Exercise Intervention Metabolic Syndrome Prostate Cancer Black Men

NCT ID: NCT02379559

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2017-02-16

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.

Conditions

Physical Activity; Metabolic Syndrome; Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Exercise Group

Eligible participants randomized into the intervention group will receive a mix of supervised moderate-intensity aerobic and light weight-resistance exercises.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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 Group

Eligible participants randomized in the attention control group will be asked to maintain their current daily activities and exercise habits for 6-months.

Group Type: ACTIVE_COMPARATOR

Attention Control

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Office of Minority Health and Health Disparities Research

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

Countries

United States

Other Identifiers

Georgetown_University_MC1

Identifier Type: -

Identifier Source: org_study_id