High-Intensity Interval Training for Women at Heightened Risk for Breast Cancer
Condition: Disorders of Breast
MeSH terms: Breast Diseases
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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, you will take part in high-intensity interval (HIIT) exercise.

        -  If you are in Group 2, you will take part in moderate-intensity exercise.

        -  If you are in Group 3, you will not take part in any assigned exercise, but you will
           receive written materials and counseling by an exercise physiologist.

      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:

        -  You will have a cardiopulmonary exercise test (CPET) to check your lung function. The
           CPET checks how well your lungs are working by measuring how much oxygen and carbon
           dioxide your lungs take in and release when you breathe. To perform this test, you will
           be asked to walk on a treadmill until you reach a point that you can no longer exercise.
           You will be breathing into the machine while you walk. This test will take about 30
           minutes to complete. The study doctor will be present for each CPET and available to
           respond to any complication.

        -  You will have an EKG to check your heart function. The study doctor will be present for
           each EKG you have.

        -  Blood (about 1½ tablespoons) will be drawn for biomarker testing. You will be asked to
           fast (eat nothing and drink only water) for at least 12 hours before each blood draw as
           part of this study.

        -  You will have a dual-energy x-ray absorptiometry (DEXA) scan to measure your body mass.

        -  You will complete a questionnaire that will ask you about your demographics (age, race,
           and so on), past medical history, and lifestyle habits. This questionnaire should take
           about 5 minutes to complete.

        -  You will complete 5 questionnaires about your quality of life, exercise experience, and
           level of fatigue. These should take a total of about 15 minutes to complete.

      At 6 weeks:

        -  You will have a CPET.

        -  You will have an EKG.

      At 12 weeks:

        -  You will have a CPET.

        -  Blood (about 1½ tablespoons) will be drawn for biomarker testing.

        -  You will have an EKG.

        -  You will have a DEXA scan.

        -  You will complete the same questionnaires that you completed at baseline.

        -  If you are in Group 1 or 2, you will be interviewed by a member of the study staff. You
           will be asked 5 questions about your experience with your assigned exercise program. It
           should take about 5 minutes to complete.

      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:

        -  Trained health professionals will be present at all study visits to address any symptoms
           during exercise. If you feel that you are having difficulty breathing, experiencing
           dizziness, or are having any heart related symptoms while exercising at home, please
           stop exercising and call 911 immediately.

        -  Clinical information such as your name, patient medical record number, age, gender, body
           mass index (BMI), zip code, and your complete medical history will be collected from
           your medical record.

        -  If you are in Group 1 or Group 2, you will receive text messages before each exercise
           session to remind you to attend. You will be responsible for any text messaging charges.
           Standard text message rates will apply.
    

Intervention name(s): Exercise; Questionnaires; Motivational Session; Phone Call; Printed Materials
Intervention type(s): Other; Behavioral; Behavioral; Behavioral; Other
Intervention description(s): 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.; 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.; One (1) time each month, participant attends a motivational session for 12 weeks.; 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.; 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.
Other intervention name(s): Surveys
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Exercise; Biomarkers; Breast cancer high risk; Treadmill; Stationary bicycle; Questionnaires; Surveys; Motivational sessions; Phone calls; Printed materials