Physical ActivitySTRONGNCT02379559
Exercise Intervention Metabolic Syndrome Prostate Cancer Black Men
A study testing Exercise in people with Physical Activity and Metabolic Syndrome, run by Georgetown University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Metabolic Syndrome, Prostate Cancer
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 16 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- African-American and/or Black men;
- between the ages of 40-70 years;
- waist circumference >40 inches (102 cm);
- with at least two of the following: elevated BP (≥ 130/85 mmHg);
- elevated fasting glucose (≥ 100 mg/dL), reduced HDL cholesterol (<50 mg/dL), or elevated triglycerides (≥ 150 mg/dL);
- sedentary defined as <60 minutes of recreation or work requiring modest PA/week;
Show all 10Show fewer
- be able to speak and read English;
- able to provide meaningful consent (i.e., men with severe cognitive impairment will be excluded);
- have no physical limitations that prevent from exercising;
- and have access to a television and DVD player.
Who cannot join
- history of cancer except nonmelanoma skin cancer;
- current enrollment in another clinical trial or weight loss program;
- 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 locations and contacts
1 site in 1 country.
United States1 site
Office of Minority Health and Health Disparities Research
Washington D.C., District of Columbia, 20003
About this study
Official title: An Exercise Intervention on Metabolic Syndrome and Prostate Cancer Risk Among Black Men
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.
- Conditions
- Physical Activity, Metabolic Syndrome, Prostate Cancer
- Being tested
- Exercise, Attention Control
- Keywords
- prostate cancer, African-American, Metabolic Syndrome, Exercise, Men's Health
- Medical subject headings
- Motor Activity, Metabolic Syndrome, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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 ControlBehavioural
We will provide weekly healthy lifestyle tips via text messages, and will include tips such as managing stressors in life and getting better sleep.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Eligible participants randomized into the intervention group will receive a mix of supervised moderate-intensity aerobic and light weight-resistance exercises. Receives: Behavioral: Exercise |
| 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. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference
Waist circumference will be measured at baseline, 3- and 6-months of the intervention
Measured: 6-months
Secondary outcomes (6)
Dietary behaviors questionnaire
Block 2005 Food Frequency Questionnaires (FFQ) at baseline, 3- and 6-months of the intervention
Measured: 6-months
Cardiovascular fitness test
Bruce treadmill protocol will be used to determine VO2max at baseline, 3- and 6-months of the intervention.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startJul 2013
- Primary completion16 Feb 2017
- Study completion16 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379559
- Sponsor's protocol ID
- Georgetown_University_MC1
- Acronym
- STRONG
- Status last verified
- Sep 2014
- First submitted
- 23 Sep 2014
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exercise Intervention on Metabolic Syndrome and Prostate Cancer Risk Among Black Men
- ClinicalTrials.gov ID
- NCT02379559
- Acronym / sponsor ID
- STRONG / Georgetown_University_MC1
- Conditions
- Physical Activity, Metabolic Syndrome, Prostate Cancer
- Keywords
- prostate cancer, African-American, Metabolic Syndrome, Exercise, Men's Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- 16 Feb 2017 (actual)
- Study completion
- 16 Feb 2017 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: ExerciseEligible participants randomized into the intervention group will receive a mix of supervised moderate-intensity aerobic and light weight-resistance exercises. |
| Attention Control Group | Active comparator | Behavioral: Attention ControlEligible participants randomized in the attention control group will be asked to maintain their current daily activities and exercise habits for 6-months. |
Who may qualify
- Ages
- 40 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- African-American and/or Black men;
- between the ages of 40-70 years;
- waist circumference >40 inches (102 cm);
- with at least two of the following: elevated BP (≥ 130/85 mmHg);
- elevated fasting glucose (≥ 100 mg/dL), reduced HDL cholesterol (<50 mg/dL), or elevated triglycerides (≥ 150 mg/dL);
Key exclusion criteria (3 listed)
- history of cancer except nonmelanoma skin cancer;
- current enrollment in another clinical trial or weight loss program;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseFor 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. | Behavioural | Exercise Group |
| Attention ControlWe will provide weekly healthy lifestyle tips via text messages, and will include tips such as managing stressors in life and getting better sleep. | Behavioural | Attention Control Group |
Primary outcome
Waist circumference
Time frame: 6-months
Waist circumference will be measured at baseline, 3- and 6-months of the intervention
6 secondary outcomes
Dietary behaviors questionnaire
Time frame: 6-months
Cardiovascular fitness test
Time frame: 6-months
Fasting glucose levels test
Time frame: 6-months
Lipid level test
Time frame: 6-months
Quality of life questionnaire (SF-36)
Time frame: 6-months
Body Mass Index (BMI)
Time frame: 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Physical Activity and Metabolic Syndrome, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist circumference (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.