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CompletedNCT02379559STRONGUpdated Feb 23, 2017

Exercise Intervention Metabolic Syndrome Prostate Cancer Black Men

An interventional study of Exercise and Attention Control in Physical Activity, Metabolic Syndrome and Prostate Cancer, sponsored by Georgetown University. Completed at 1 site in United States. Open to male participants aged 40 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Georgetown University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
40 Years to 40 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Physical Activity
  • Metabolic Syndrome
  • Prostate Cancer

Keywords

  • prostate cancer
  • African-American
  • Metabolic Syndrome
  • Exercise
  • Men's Health
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 10 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Georgetown University is the lead sponsor of 286 studies on the registry; 42 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Exercise Group

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

    Behavioral: Exercise

  • Active comparator
    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.

    Behavioral: Attention Control

Interventions

  • BehavioralExercise

    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.

  • BehavioralAttention 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.

06

What researchers measure

Primary outcomes

  1. Waist circumference

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

    Time frame: 6-months

Secondary outcomes

  1. Dietary behaviors questionnaire

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

    Time frame: 6-months

  2. Cardiovascular fitness test

    Bruce treadmill protocol will be used to determine VO2max at baseline, 3- and 6-months of the intervention.

    Time frame: 6-months

  3. 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.

    Time frame: 6-months

  4. 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.

    Time frame: 6-months

  5. 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.

    Time frame: 6-months

  6. Body Mass Index (BMI)

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

    Time frame: 6-months

07

Study locations

1 site
  • Office of Minority Health and Health Disparities Research
    Washington, District of Columbia 20003, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02379559
Lead sponsor
Georgetown University
Responsible party
Sponsor
First posted
Mar 5, 2015
Start date
Jul 2013
Primary completion
Feb 16, 2017
Completion
Feb 16, 2017
Last update
Feb 23, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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