Exercise Programs for High-Risk Metabolic Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two exercise programs to determine if they can reduce breast cancer risk in African-American women with metabolic syndrome. Metabolic syndrome includes conditions like high blood pressure and high blood sugar, which can increase breast cancer risk. Participants will join either a supervised exercise group (facility-based exercise), a home-based exercise group, or a control group with no new exercise plan. Women who are postmenopausal, have a waist measurement over 35 inches, and live near the Navy Yard stop might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to important research that could improve health outcomes for African-American women.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use anti-diabetic medication, including insulin.
Is there any evidence suggesting that this trial's exercise interventions are likely to be safe?
Research has shown that supervised exercise programs can improve metabolic syndrome, a group of conditions that increase the risk of heart disease, stroke, and diabetes. These programs are particularly effective at reducing waist size and are generally safe and well-tolerated by participants.
For exercise done at home, studies indicate that people at high risk for heart problems can start safely. These programs usually focus on walking and other moderate activities, which are unlikely to cause harm. Participants often adhere to these programs and report satisfaction, suggesting they find them manageable and safe.
Both types of exercise programs have demonstrated positive results in reducing health risks without significant side effects, indicating they are generally safe for most people to try.12345Why are researchers excited about this trial?
Researchers are excited about these exercise programs for high-risk metabolic syndrome because they offer structured, practical ways to manage this condition through physical activity. The facility-based exercise intervention provides supervised workouts, using heart rate and perceived exertion to ensure participants engage in effective, moderate-intensity exercise. On the other hand, the home-based program offers flexibility, allowing participants to integrate exercise into their daily routines by aiming for 10,000 steps per day, tracked via pedometers. These approaches could make regular exercise more accessible and sustainable compared to traditional gym memberships or personal training, potentially leading to better long-term health outcomes for those at risk of metabolic syndrome.
What evidence suggests that this trial's exercise interventions could be effective for metabolic syndrome?
Research has shown that exercise can improve metabolic syndrome (MetS) by positively affecting body weight and heart health. This trial will compare different exercise programs. Participants in the facility-based exercise intervention arm will engage in supervised exercise, which studies have found often boosts fitness, helps control blood sugar, and improves cholesterol and fat levels. Meanwhile, those in the home-based exercise intervention arm will follow a home-based program, which can include remote monitoring and has also been effective in reducing MetS risk factors. Both methods aim to achieve similar benefits, such as weight loss and improved heart health. Exercise programs, whether supervised or done independently, show promise for managing MetS and may also lower the risk of breast cancer.678910
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete baseline assessments prior to randomization
Treatment
Participants engage in either a supervised facility-based or home-based exercise intervention for 6 months
Follow-up
Participants are monitored for changes in biomarkers and health-related quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Facility-based Exercise
- Home-based Exercise
Trial Overview
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.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Georgetown University
Lead Sponsor
Published Research Related to This Trial
Citations
Effectiveness of Physical Exercise on Indicators of Metabolic ...
Objectives: This purpose of this study was to analyze the effectiveness of changes in biochemical, physiological, and anthropometric indicators ...
Supervised lifestyle intervention for people with metabolic ...
There is low to moderate quality evidence that supervised multifaceted lifestyle intervention improves multiple risk factors of metabolic syndrome.
The effect of exercise training on clinical outcomes in patients ...
Exercise training improves body composition, cardiovascular, and, metabolic outcomes in people with metabolic syndrome.
Physical activity in metabolic syndrome - PMC
Early implementation of exercise leads to improved physical fitness, better glycemic control and lipid profile. Undertaking systematic PA is associated with ...
Enhanced Lifestyles for Metabolic Syndrome (ELM)
This is a multi-center behavioral randomized trial with the aim of comparing a group-based lifestyle intervention with a self-directed lifestyle intervention.
The Impact Of Structured Exercise Programs On Metabolic ...
Supervised exercise programs yield significant resolution of components of the MetS, particularly in reducing waist circumference.
Systematic review Physiotherapist-led health promotion ...
This systematic review found moderate to high certainty evidence to support the use of physiotherapist-led health promotion interventions ...
Feasibility of a Home-Based Exercise Program ...
This study aims to evaluate the feasibility (ie, recruitment rate, program adherence, attrition, safety, and participant satisfaction) of a 12-week ...
Supervised lifestyle intervention for people with metabolic ...
There is low to moderate quality evidence that supervised multifaceted lifestyle intervention improves multiple risk factors of metabolic syndrome.
Telemonitoring-supported exercise training, metabolic ...
Our results show that regular and telemonitoring-supported physical activity decreased metabolic syndrome severity while increasing work ability ...
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