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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01938 | Registry Identifier | NCI CTRP |
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The goal of this research study is to learn if there is a level of exercise training that is more effective in lowering biomarker levels that are linked to breast cancer risk. Biomarkers are found in the blood/tissue and may be related to your reaction to exercise.
This is an investigational study. Up to 72 participants will be enrolled in this study. All will take part at MD Anderson.
Study Groups:
If you agree to take part in this research study, you will be randomly assigned (as in a roll of dice) to 1 of 3 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being assigned to each group:
If you are in Group 1 or Group 2, you will also receive written materials and instructions on how to perform your exercises.
Physical Activity:
If you are in Group 1 or 2, you will come to the Energy Balance Center to exercise 3 times a week for 12 weeks.
If you are in Group 1, you will walk uphill on a treadmill for a total of 33 minutes. There will be a 5-minute warm up, followed by four 4-minute intervals. Between each interval, you will walk for 3 minutes. There will be a 3 minute cool down.
If you are in Group 2, you will exercise at the Energy Balance Center 3 times a week. You will walk uphill on a treadmill or use a stationary bicycle continuously for 41 minutes.
If you are in Group 3, 1 time each month while you are on study, you will be called by a member of the study staff and asked about any exercise you have done and your weight loss goals. Each phone call should take about 15 minutes.
The exercise training intensity may be reduced or stopped temporarily if you experience side effects.
Length of Study:
No matter which group you are in, your participation in this study will be over after 12 weeks. You will be taken off study if you have intolerable side effects.
Study Visits:
All participants will visit the MD Anderson Behavioral Research and Treatment Center for each study visit.
At baseline:
At 6 weeks:
At 12 weeks:
One (1) time each month, you will attend a motivational session. During this session, you will discuss strategies for overcoming barriers that may be keeping you from attending or completing your exercises. You will also talk about continuing physical activity after you complete the program. This session should last about 15-30 minutes.
Additional Information:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Intensity Interval Training (HIIT) Group | Experimental | Participants come to the Energy Balance Center to exercise 3 times a week for 12 weeks. Participants receive written materials and instructions on how to perform their exercises. Participants walk uphill on a treadmill for a total of 33 minutes 3 times a week for 12 weeks. Participants complete questionnaires about their quality of life, exercise experience, and level of fatigue at baseline and at 12 weeks. One (1) time each month, participant attends a motivational session. |
|
| Moderate-Intensity Continuous Training (MICT) Group | Experimental | Participants come to the Energy Balance Center to exercise 3 times a week for 12 weeks. Participants receive written materials and instructions on how to perform their exercises. Participants walk uphill on a treadmill or use a stationary bicycle continuously for 41 minutes 3 times a week for 12 weeks. Participants complete questionnaires about their quality of life, exercise experience, and level of fatigue at baseline and at 12 weeks. One (1) time each month, participant attends a motivational session. |
|
| Control Group | Active Comparator | Participants receive written materials and counseling by an exercise physiologist. Participants called by a member of the study staff 1 time each week for 12 weeks and asked about any exercise they have done and their weight loss goals. Participants complete questionnaires about their quality of life, exercise experience, and level of fatigue at baseline and at 12 weeks. One (1) time each month, participant attends a motivational session. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | High-Intensity Interval Training (HIIT) Group: Participants walk uphill on a treadmill for a total of 33 minutes 3 times a week for 12 weeks.There is a 5-minute warm up, followed by four 4-minute intervals. Between each interval, participant walks for 3 minutes. There is a 3 minute cool down. Moderate-Intensity Continuous Training (MICT) Group: Participants walk uphill on a treadmill or use a stationary bicycle continuously for 41 minutes 3 times a week for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of High-Intensity Interval Exercise to Offset the Tumor Promoting Effects of Obesity in High-Risk Breast Cancer Participants | Trials judged feasible if: At least 45% of screened patients meet inclusion criteria, 2. At least 50% of patients who meet the inclusion criteria consent, 3. Adherence in HIIT and MICT is larger than 80%, and 4. Retention rate is larger than 80%. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan C. Gilchrist, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33555464 | Derived | Coletta AM, Agha NH, Baker FL, Niemiro GM, Mylabathula PL, Brewster AM, Bevers TB, Fuentes-Mattei E, Basen-Engquist K, Gilchrist SC, Simpson RJ. The impact of high-intensity interval exercise training on NK-cell function and circulating myokines for breast cancer prevention among women at high risk for breast cancer. Breast Cancer Res Treat. 2021 Jun;187(2):407-416. doi: 10.1007/s10549-021-06111-z. Epub 2021 Feb 8. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D001941 | Breast Diseases |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Questionnaires | Behavioral | Participants complete questionnaires about their quality of life, exercise experience, and level of fatigue at baseline and at 12 weeks. These should take a total of about 15 minutes to complete. |
|
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| Motivational Session | Behavioral | One (1) time each month, participant attends a motivational session for 12 weeks. |
|
| Phone Call | Behavioral | Participants called by a member of the study staff 1 time each week for 12 weeks and asked about any exercise they have done and their weight loss goals. Each phone call should take about 15 minutes. |
|
| Printed Materials | Other | High-Intensity Interval Training (HIIT) Group and Moderate-Intensity Continuous Training (MICT) Group: Participants receive written materials and instructions on how to perform their exercises. Control Group: Participants receive written materials and counseling by an exercise physiologist. |
|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |