Exercise Programs for High-Risk Metabolic Syndrome

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Georgetown University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

213 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment for high-risk metabolic syndrome?

A study on a home-based exercise program with IT support showed significant improvements in blood pressure, cholesterol, and triglycerides, and reversed metabolic syndrome in 16% of participants, suggesting that such programs can be effective for managing metabolic syndrome. ^{1 2 3 4 5}

Is exercise safe for people with metabolic syndrome?

Exercise programs, whether done at home or in a facility, are generally safe for people with metabolic syndrome. Studies show that regular physical activity can improve heart health and other risk factors without significant safety concerns. ^{1 5 6 7 8}

How is the exercise program treatment for metabolic syndrome different from other treatments?

This treatment is unique because it offers both facility-based and home-based exercise options, potentially using telemonitoring to make it more accessible and personalized. Unlike standard treatments that may focus on medication, this approach emphasizes lifestyle changes through regular exercise, which can be more sustainable and cost-effective in managing metabolic syndrome. ^{6 7 9 10 11}

Eligibility Criteria

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

Have a cell phone with texting capabilities

Have medical clearance from a physician or nurse practitioner

I am a postmenopausal African-American woman, aged 45-65, with a waist over 35 inches.

Exclusion Criteria

I have not gone through menopause.

I have had cancer before, but not skin cancer.

I cannot exercise due to physical limitations.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants complete baseline assessments prior to randomization

1 week

1 visit (in-person)

Treatment

Participants engage in either a supervised facility-based or home-based exercise intervention for 6 months

24 weeks

Bi-weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for changes in biomarkers and health-related quality of life

4 weeks

2 visits (in-person)

Treatment Details

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.

Participant Groups

Group I: Home-Based Exercise Intervention Experimental Treatment 1 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 Intervention Experimental Treatment 1 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: Control Active Control 1 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.

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

Findings from Research

The Best Exerciser Super Trainer program, designed for Korean male workers with metabolic syndrome, showed significant cardiovascular risk reduction after 8 weeks, including decreases in waist circumference, diastolic blood pressure, and fasting plasma glucose.

An expert evaluation indicated strong approval of the program's content, suggesting that the Internet-based approach effectively promotes lifestyle modifications tailored to individual readiness for physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and a pilot test of an internet-based cardiovascular risk reduction program for Korean male workers with metabolic syndrome. Kim, CJ., Kang, S.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Home-based exercise may not decrease the insulin resistance in individuals with metabolic syndrome. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of a lifestyle therapy program using cardiac rehabilitation resources on metabolic syndrome components. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effect of an IT-supported home-based exercise programme on metabolic syndrome in India. [2019]

4. England pubmed.ncbi.nlm.nih.gov

A nurse-led lifestyle intervention using mobile application versus booklet for adults with metabolic syndrome-Protocol for a randomized controlled trial. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of IVRS-based mHealth intervention in reducing cardiovascular risk in metabolic syndrome: A cluster randomized trial. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Physiological and psychological effects of a 12-week home-based telemonitored training in metabolic syndrome. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Primary prevention of metabolic syndrome in the community using an evidence-based exercise program. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Transcriptional changes in blood after aerobic interval training in patients with the metabolic syndrome. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Development and a pilot test of an internet-based cardiovascular risk reduction program for Korean male workers with metabolic syndrome. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Aerobic interval training versus continuous moderate exercise as a treatment for the metabolic syndrome: a pilot study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Effect of Yearly Exercise on Medication Expense and Benefit-Cost Ratio in Individuals with Metabolic Syndrome: A Randomized Clinical Trial. [2023]