Exercise Intervention Metabolic Syndrome Prostate Cancer Black Men (STRONG)

Georgetown University

Status: Completed

Conditions: Physical Activity; Prostate Cancer; Metabolic Syndrome

Treatments: Behavioral: Attention Control; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02379559

Georgetown_University_MC1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Male

Ages: 40 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

10 participants in 2 patient groups

Exercise Group

Experimental group

Description:

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

Treatment:

Behavioral: Exercise

Attention Control Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Attention Control