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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

No Placebo-Only Group

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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 more

Secondary study objectives

Body composition

Cardiorespiratory fitness

Health-related Quality of Life

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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