Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Breast Neoplasms

Syndrome

Obesity

Metabolic Syndrome

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

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.

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.

Facility-based Exercise

Home-based Exercise

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.

1. To assess the impact of exercise on biomarkers related to obesity, insulin-related pathways, inflammation, hormones, and microRNAs.
2. The primary aim of this study is to compare the effect of 2 types of exercise interventions (supervised and self-directed compared to control) on biological parameters related to breast cancer development. It is important to understand if participants in this study respond better to an exercise program they are able to engage in on their own (self-directed) or if participating in an exercise program under supervision is preferred. A study by Pinto utilized a home-based exercise program among breast cancer survivors and commented that the home-based program has several advantages including 1) mitigating transportation and scheduling difficulties, and 2) is less expensive than supervised programs. Another study compared the effect of a supervised exercise program to a self-directed exercise group and a control group on physical functioning and health-related quality of life among breast cancer survivors and found that participants in the self-directed exercise group improved their physical functioning to a somewhat greater degree than the supervised group. The authors proposed that one reason for this result could be attributed to the fact that the self-directed program included many features thought to comprise effective home training including the following: baseline fitness evaluations, written guidelines for home exercise, education about pulse checking/heart rate guidelines, daily activity logs and bi-weekly telephone calls by the exercise specialist. In the current study, we plan to employ features similar to the self-directed exercise program in an effort to determine if the self-directed group improves to a greater extent than the control group and better or comparable to the supervised group. An added feature of the current study is that we will administer a participant satisfaction questionnaire to assess each participant's experience in their respective groups. This information will, in part, help us to plan future studies. All participants will complete a baseline assessment prior to randomization, as indicated in Table 1 in the attached grant proposal; follow-up measures will also be conducted as indicated in that table. Participants will be required to provide a medical clearance from their health care provider or a nurse practitioner.
3. \* Rationale and justification for study (i.e. historical background, investigator's personal experience, pertinent medical literature, etc.): In the United States, breast cancer is the most commonly diagnosed cancer in women, other than non-melanoma skin cancer, and is the second most common cause of cancer deaths among women. Several risk factors have been identified that increase breast cancer risk, some of which are non-modifiable (e.g., age, family history, and race) and some of which are modifiable (e.g., physical activity, body weight, dietary habits, and alcohol intake). Breast cancer rates, which are increasing worldwide, parallel the increases in lifestyle diseases including Type 2 diabetes, obesity, and metabolic syndrome (MetS). MetS represents a cluster of risk factors associated with increased risk of cardiovascular diseases, and includes several components individually related to breast cancer etiology, i.e., central obesity, hypertension, hyperglycemia, and low high-density lipoprotein cholesterol. However, recent studies have suggested that MetS is underdiagnosed in African-American women because they are less likely to have decreased HDL or increased triglycerides as compared to women of other races/ethnicities. Breast cancer is hormone related and thus, the effects of established risk factors for the disease, including obesity, differ before to after menopause. Among African-American women, in whom 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. The American Cancer Society (ACS) and the International Agency for Research on Cancer of the World Health Organization now both recommend regular physical activity as a strategy for women to reduce their risk of developing breast cancer. Specific recommendations for breast cancer prevention, which initially emphasized diet, are now focused on maintaining a healthy weight throughout life by balancing caloric intake while increasing caloric expenditure via increased physical activity levels, and losing weight if overweight or obese.

Obesity itself is a major public health problem and is associated with increased postmenopausal breast cancer incidence and mortality. Our proposed 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 (based on the CARE model).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, and hormones. 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.

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

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

Serum IL-6, TNF-alpha, High sensitivity CRP

Fasting glucose, seruminsulin, IGF-1, IGFBP-3

Greater improvements in metabolic syndrome and metabolic syndrome components

VO2Max using the Bruce treadmill protocol

Measured using DEXA scan: fat mass, lean mass

Georgetown University

Breast Diseases

Skin Diseases

Exercise Intervention: Participants in the Wii Fit exergaming group will have a goal of 150 min/wk of moderate intensity exercise for the last 5 mo of the 6 mo intervention. Heart rate (HR) monitors will quantify exercise intensity. Participants will exercise at a HR equal to 45-65% of their VO2max. Participants will be instructed by the exercise physiologist on how to achieve the required HR. The training will consist of 3 days/wk of supervised Wii Fit physical activity. Exercise duration will increase gradually from 75 to 150 min/wk by wk 477. Thereafter, women will maintain \>150 min/wk of moderate-intensity physical activity. Participants will complete daily exercise diaries recording the type and duration of physical activity, and HR.

Control Group: After baseline testing the control group will be asked to maintain their current daily activities for the duration of the study. The control group will have the option to exercise at the Wii Fit stations following their completion of the study. They will receive the same measures as the exercise group.

The participants in the Wii Fit exergaming group will be encouraged to meet and then maintain a goal of 150 min/wk of moderate intensity exercise for 6 months. Goals per individual will be based on their baseline data. Exercise duration will increase gradually from 75 min/wk at week 1 to 150 min/wk by week 4. Thereafter, women will maintain \>150 min/wk of moderate-intensity physical activity. The training will consist of 3 days/wk of supervised physical activity using Nintendo Wii Fit active videogames.

Exergaming

Lucile L Adams-Campbell, PhD

Overview: This is a 6 month, two-arm randomized clinical trial using comparing exergaming to a control group. The investigators will randomize Black sedentary overweight/obese women to Wii Fit exercise (n=50) or the control arm (n=50). Women in the Wii Fit exercise group will come to the Georgetown community-based exercise facility 3 days/wk. The control group will be asked to maintain their current daily activities and not to exercise for the duration of the study. Based on the investigators previous findings that women who engage in 75-150 mins/wk of brisk walking had an 18% decreased risk of breast cancer, the investigators will target this level of activity in the investigators intervention arm. Also, this 150 min/week of physical activity meets the current recommendations of the American College of Sports Medicine (ACSM) and the US Department of Health and Human Services for healthy individuals and is in line with recommendation of the American Cancer Society (ACS) for cancer prevention.

1. \* Purpose of project (one or two sentences): To examine the feasibility and acceptability of an exergaming intervention in a community-based setting, and to explore the effects of exergaming on cardiovascular fitness, body mass index and percent body fat in Black women who are sedentary and overweight or obese.
2. \* Study design (for example, hypothesis, research questions, standard and experimental procedures/drugs/devices or equipment, etc.):

Overview: This is a 6 month, two-arm randomized clinical trial using comparing exergaming to a control group. The investigators will randomize Black sedentary overweight/obese women to Wii Fit exercise (n=50) or the control arm (n=50). Women in the Wii Fit exercise group will come to the Georgetown community-based exercise facility 3 days/wk. The control group will be asked to maintain their current daily activities and not to exercise for the duration of the study. Based on the investigators previous findings that women who engage in 75-150 mins/wk of brisk walking had an 18% decreased risk of breast cancer, the investigators will target this level of activity in the investigators intervention arm. Also, this 150 min/week of physical activity meets the current recommendations of the American College of Sports Medicine (ACSM) and the US Department of Health and Human Services for healthy individuals and is in line with recommendation of the American Cancer Society (ACS) for cancer prevention.

Exercise Intervention: Participants in the Wii Fit exergaming group will have a goal of 150 min/wk of moderate intensity exercise for the last 5 mo of the 6 mo intervention. Heart rate (HR) monitors will quantify exercise intensity. Participants will exercise at a HR equal to 45-65% of their maximal oxygen consumption (VO2max). Given the expected VO2max values for this population, the investigators project that the Wii Fit videogames must elevate energy expenditure to 3-4 times resting metabolic rate to achieve the desired HR responses. As summarized above, previous studies have shown that such an elevation in energy expenditure can be expected from these activities. Wii Fit stations with a variety of active games will be available to participants at the Georgetown University Community Based Office. Participants will be instructed by the exercise physiologist on how to achieve the required HR. The training will consist of 3 days/wk of supervised Wii Fit physical activity. Exercise duration will increase gradually from 75 to 150 min/wk by wk 477. Thereafter, women will maintain \>150 min/wk of moderate-intensity physical activity. Participants will complete daily exercise diaries recording the type and duration of physical activity, and HR.

Control Group: After baseline testing the control group will be asked to maintain their current daily activities for the duration of the study. The control group will have the option to exercise at the Wii Fit stations following their completion of the study. They will receive the same measures as the exercise group.

Diet: Participants in both groups will be instructed to maintain their diet constant throughout the study. Wii Fit intervention participants will be weighed at every session and those losing more weight than could be accounted for by their exercise will be counseled to return to their caloric intake at the start of the study.

\* Rationale and justification for study (i.e. historical background, investigator's personal experience, pertinent medical literature, etc.): Several risk factors have been identified that increase breast cancer risk, some of which are non-modifiable factors (e.g., age, family history, and race) and some of which are modifiable (e.g., physical activity, body weight, dietary habits, and alcohol intake). However, only within the last 10 years have cancer organizations started to recommend physical activity as a preventive measure for breast cancer. The American Cancer Society (ACS) and the International Agency for Research on Cancer of the World Health Organization now both recommend regular physical activity as a strategy for women to reduce their risk of developing breast cancer. Specific recommendations for breast cancer prevention, which initially focused on diet, are now focused on maintaining a healthy weight throughout life by balancing caloric intake while increasing caloric expenditure via increased physical activity levels, and losing weight if overweight or obese. Obesity itself is a significant public health problem and is associated with increased postmenopausal breast cancer incidence and mortality. This research proposal will assess a novel method to improve physical activity in African American women, who are generally less physically active and more overweight and obese than women of most other racial and ethnic groups.

* Treatment Plan:

The participants in the Wii Fit exergaming group will be encouraged to meet and then maintain a goal of 150 min/wk of moderate intensity exercise for 6 months. Goals per individual will be based on their baseline data. Exercise duration will increase gradually from 75 min/wk at week 1 to 150 min/wk by week 4. Thereafter, women will maintain \>150 min/wk of moderate-intensity physical activity. The training will consist of 3 days/wk of supervised physical activity using Nintendo Wii Fit active videogames.

Participants will exercise at a HR equal to 45-65% of their VO2max. Given the expected VO2max values for this population, the investigators project that the Wii Fit videogames will elevate energy expenditure to 3-4 times resting metabolic rate to achieve the desired HR responses. As summarized above, previous studies have shown that such an elevation in energy expenditure can be expected from these activities. Participants will be instructed to monitor their physical activity in order to assist with their perceived behavioral control and increase self-efficacy towards meeting their goals.

During aerobic exercise sessions, participants will wear Polar heart rate monitors to determine exercise intensity and will be given instruction by the exercise physiologist on how achieve the required HR. In addition, participants will complete daily exercise diaries to record the type and duration of physical activity, and exercise HR. Because many women may not have access to gym memberships or be able to afford expensive exercise equipment, the investigators address this environmental barrier by establishing Wii Fit stations with a variety of active games available to participants at the Community Based Office.

Exergames selected for use during the exercise sessions will be chosen based on energy expenditure data. Those active videogames that have been shown to achieve energy expenditure levels above those necessary to achieve 60% HRmax in the investigators specific study population will be selected. For example, active videogames tested in published studies, such as Wii Fit boxing and Dance Dance Revolution, have been found to achieve physical activity levels of moderate intensity (3.0-6.0 METs), which meet American College of Sports Medicine guidelines for health and fitness. Graves et al. (2008), for example found physical activity levels to reach 68% of maximal heart rate (HRmax) using the Wii Fit which also meets ACSM aerobic fitness recommendations (60% HRmax).

Exergaming Intervention and Breast Cancer Biomarkers in Black Women

Outcomes for plasma leptin, adiponectin, Insulin-like growth factor 1 (IGF-1), Insulin-like growth factor-binding protein 3 (IGFBP3), C-reactive protein (CRP), Interleukin 6 (IL-6), insulin, c-peptide, and Hb-A1c levels at baseline and 24 weeks.

Cardiovascular fitness is measured using metabolic cart at baseline, 12 weeks, and 24 weeks.

Reported stressed levels was assessed using the Perceived Stress Scale (PSS) at baseline, 12 weeks, and 24 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Exercise RCT Targeting African-American Women With Metabolic Syndrome and High Risk for Breast Cancer	NCT02103140	Metabolic Syndr... Obesity	Facility-based ... Home-based Exer...	45 Years - 65 Years	Georgetown University
Exergaming Intervention and Breast Cancer Biomarkers in Black Women	NCT02152462	Breast Cancer Obesity	Exergaming	40 Years - 59 Years	Georgetown University
An Exercise RCT Targeting African-American Women With Metabolic Syndrome and High Risk for Breast Cancer	NCT02103140	Metabolic Syndr... Obesity	Facility-based ... Home-based Exer...	45 Years - 65 Years	Georgetown University
An Exercise RCT Targeting African-American Women With Metabolic Syndrome and High Risk for Breast Cancer	NCT02103140	Metabolic Syndr... Obesity	Facility-based ... Home-based Exer...	45 Years - 65 Years	Georgetown University

Spots Global Cancer Trial Database for exergaming

Every month we try and update this database with for exergaming cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for exergaming

Every month we try and update this database with for exergaming cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for exergaming cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.