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An Exercise RCT Targeting African-American Women With Metabolic Syndrome and High Risk for Breast Cancer

NCT02103140 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2024-02-20

No results posted yet for this study

Summary

Among African-American women, in whom metabolic syndrome (MetS) is very prevalent and breast cancer mortality rates are high, it is hypothesized that intervening on MetS to improve the MetS profile may prove to be a means to reduce breast cancer risk. Specific recommendations for breast cancer prevention are now focused on maintaining a healthy weight via increased physical activity levels, and losing weight if overweight or obese.

This pilot project compares two exercise interventions: a supervised facility-based and a home-based exercise intervention to a control group in African-American women with metabolic syndrome who are at high risk for breast cancer. This study is a 6-month three-arm RCT to assess the impact of the exercise interventions on biomarkers related to obesity, insulin-related pathways, inflammation, hormones, and micro-RNAs.

The specific aim of the proposed study is to compare the impact of a supervised facility-based and a home-based exercise intervention on obesity, metabolic syndrome and known breast cancer biomarkers in postmenopausal African-American women with metabolic syndrome who are at increased risk of breast cancer.

Conditions

Interventions

BEHAVIORAL

Facility-based Exercise

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.

BEHAVIORAL

Home-based Exercise

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.

Sponsors & Collaborators

  • Georgetown University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2023-09-30
Completion
2025-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02103140 on ClinicalTrials.gov