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Exercise Programs for High-Risk Metabolic Syndrome
N/A
Waitlist Available
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Summary
This trial is testing whether two different exercise interventions can reduce risk factors for breast cancer in postmenopausal African-American women with metabolic syndrome.
Who is the study for?
This trial is for African-American postmenopausal women aged 45-65 with metabolic syndrome, living near the Navy Yard stop on the green line. They must read and speak English, have a cell phone, be able to consent, get medical clearance, and not be pregnant or planning pregnancy. Excluded are those in other trials, on weight loss programs or with physical limitations preventing exercise.
What is being tested?
The study compares two types of exercise interventions: supervised facility-based and home-based exercises against no intervention in reducing obesity-related biomarkers that may increase breast cancer risk. It's a 6-month randomized controlled trial focusing on improving metabolic health to potentially lower breast cancer risk.
What are the potential side effects?
Since this trial involves exercise interventions rather than medication, side effects might include typical exercise-related issues such as muscle soreness or strain. However, these activities are generally considered safe when performed correctly and within one's limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Biomarkers of breast cancer risk - adipokines
Biomarkers of breast cancer risk - biomarkers of inflammation
Biomarkers of breast cancer risk - biomarkers of insulin pathway
+3 moreSecondary study objectives
Body composition
Cardiorespiratory fitness
Health-related Quality of Life
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Home-Based Exercise InterventionExperimental Treatment1 Intervention
Home-Based Exercise Intervention Group The participants randomized to this intervention arm will be required to meet and maintain a goal of 150 min/wk of moderate intensity exercise for 6 months, the same as the supervised intervention group. Their exercise goal will be to achieve a total of 10,000 steps per day, as measured by pedometers. Participants will be required to have a cell phone with text messaging capabilities.
Group II: Facility-Based Exercise InterventionExperimental Treatment1 Intervention
Supervised Facility-Based Exercise Intervention Arm The participants randomized to the exercise group will be required to meet and maintain a goal of 150 min/wk of moderate intensity exercise for 6 months. This intervention will use heart rate and rating of perceived exertion (RPE) to define moderate intensity. Participants will exercise for the prescribed duration at a heart rate in the range of 45-65% of their maximal oxygen consumption (VO2 max), as determined during baseline testing, and with an RPE in the range of 11-14 on the 20-point scale. The exercise will primarily utilize treadmills and exercise bikes.
Group III: ControlActive Control1 Intervention
After baseline testing, the control group will be asked to maintain their current daily activities and exercise habits for the duration of the study (6 months). The control group will have measurements at the same time periods as the participants in the intervention arm through the completion of the study. Participants will be seen for follow-up at 3 and 6 months (study completion). The participants in the control group will receive the same incentives as those in the intervention arms (gift cards). Since the women in the control group are obese, with components of metabolic syndrome, and at relatively high risk for breast cancer, we are providing healthy lifestyle information to the group, via text messages.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Home-based Exercise
2012
Completed Phase 1
~90
Find a Location
Who is running the clinical trial?
Georgetown UniversityLead Sponsor
346 Previous Clinical Trials
136,997 Total Patients Enrolled
2 Trials studying Metabolic Syndrome
60 Patients Enrolled for Metabolic Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not gone through menopause.I have had cancer before, but not skin cancer.I cannot exercise due to physical limitations.I use medication to manage my diabetes.You are currently participating in a research study about exercise or diet.Currently participating in a program to lose weight.I have diabetes.I cannot commit to the scheduled treatment plan.I am a postmenopausal African-American woman, aged 45-65, with a waist over 35 inches.I have high fasting glucose (≥100 mg/dL) or high blood pressure (≥130/85 mmHg).My 5-year breast cancer risk is over 1.40% according to the CARE model.You live near or can easily get to the Navy Yard stop on the green line.
Research Study Groups:
This trial has the following groups:- Group 1: Facility-Based Exercise Intervention
- Group 2: Control
- Group 3: Home-Based Exercise Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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