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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Group | Experimental | Eligible participants randomized into the intervention group will receive a mix of supervised moderate-intensity aerobic and light weight-resistance exercises. |
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| Attention Control Group | Active Comparator | Eligible participants randomized in the attention control group will be asked to maintain their current daily activities and exercise habits for 6-months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Waist circumference | Waist circumference will be measured at baseline, 3- and 6-months of the intervention | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary behaviors questionnaire | Block 2005 Food Frequency Questionnaires (FFQ) at baseline, 3- and 6-months of the intervention | 6-months |
| Cardiovascular fitness test | Bruce treadmill protocol will be used to determine VO2max at baseline, 3- and 6-months of the intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Office of Minority Health and Health Disparities Research | Washington D.C. | District of Columbia | 20003 | United States |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D024821 | Metabolic Syndrome |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 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. |
|
| 6-months |
| 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 |
| 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 |
| 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 |
| 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 |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |