Exercise in Improving Health and Quality of Life in Breast Cancer Survivors
NCT ID: NCT03679559
Last Updated: 2023-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
83 participants
INTERVENTIONAL
2017-10-06
2022-06-02
Brief Summary
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Detailed Description
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I. To assess the feasibility of conducting a 12-week preference option randomized exercise intervention program in breast cancer survivors.
SECONDARY OBJECTIVE:
I. To assess the adherence rate of each of the four 12-week intervention programs by breast cancer survivors in a randomized treatment arm and a patient preference arm.
OUTLINE: Participants are randomized into 1 of 5 arms.
ARM I: Participants wear Fitbit, receive home-based DVD containing instructions to warm-up and cool-down, and walk 10000 steps per day over 12 weeks in order to achieve the 150 minutes per week of moderate intensity exercise. Participants also undergo resistance training by watching the illustration video and completing 6 total blocks of 2-week per block exercise using the Thera-BandR exercise bands.
ARM II: Participants wear Fitbit and receive a XBOX system and the video game to strive for at least 3 50-minute medium or high intensity classes per week over 12 weeks. Participants may also take 20-minute classes or a mixture of 50- and 20-minute classes to meet the target. Participants undergo resistance training as in Arm I.
ARM III: Participants wear Fitbit and attend supervised High Intensity Interval Training (HIIT) exercise sessions 3 days per week over 12 weeks. Participants undergo resistance training as in Arm I.
ARM IV: Participants wear Fitbit and attend supervised moderate intensity walking sessions weekly for 50-60 each over 12 weeks. Participants undergo resistance training as in Arm I.
ARM V: Participants wear Fitbit and continue their usual physical activity over 12 weeks.
After completion of study intervention, participants are followed up at 2 weeks and 1 month.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (home-based walking program, resistance training)
Participants wear Fitbit, receive home-based DVD containing instructions to warm-up and cool-down, and brisk walk 30 minutes per day 5 days a week in order to achieve the 150 minutes per week of moderate intensity exercise. Participants also receive resistance training by watching the illustration video and completing 6 total blocks of 2-week per block exercise using the Thera-BandR exercise bands.
Exercise Intervention (home walking program and resistance training)
Complete home-based walking program and resistance training
Exercise Intervention (HIIT program and resistance training)
Complete HIIT program and resistance training
Informational Intervention
Watch video
Laboratory Biomarker Analysis
Correlative studies
Monitoring Device
Wear Fitbit
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (home-based Zumba program, resistance training)
Participants wear Fitbit and receive a XBOX system and the video game to strive for at least 3 50-minute medium or high intensity classes per week over 12 weeks. Participants may also take 20-minute classes or a mixture of 50- and 20-minute classes to meet the target. Participants receive resistance training as in Arm I.
Exercise Intervention (home-based Zumba program and resistance training)
Complete home-based Zumba program and resistance training
Informational Intervention
Watch video
Laboratory Biomarker Analysis
Correlative studies
Monitoring Device
Wear Fitbit
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm III (HIIT, resistance training)
Participants wear Fitbit and attend supervised HIIT exercise sessions 3 days per week over 12 weeks. Participants receive resistance training as in Arm I.
Exercise Intervention (HIIT program and resistance training)
Complete HIIT program and resistance training
Informational Intervention
Watch video
Monitoring Device
Wear Fitbit
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm IV (supervised moderate intensity walking program)
Participants wear Fitbit and attend supervised moderate intensity walking sessions weekly for 50-60 each over 12 weeks. Participants undergo resistance training as in Arm I.
Exercise Intervention (HIIT program and resistance training)
Complete HIIT program and resistance training
Arm V (usual physical activity)
Participants wear Fitbit and continue their usual physical activity over 12 weeks.
Best Practice
Continue usual physical activity
Interventions
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Best Practice
Continue usual physical activity
Exercise Intervention (home walking program and resistance training)
Complete home-based walking program and resistance training
Exercise Intervention (home-based Zumba program and resistance training)
Complete home-based Zumba program and resistance training
Exercise Intervention (HIIT program and resistance training)
Complete HIIT program and resistance training
Informational Intervention
Watch video
Laboratory Biomarker Analysis
Correlative studies
Monitoring Device
Wear Fitbit
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a previous history of invasive breast cancer who have completed treatment except for hormonal therapy and zoledronic acid (Zometa)
* Do not meet the United States (U.S.) Center for Disease Control and Prevention's physical activity guidelines (150 minutes or 2 hours and 30 minutes a week of moderate-intensity exercise)
* Meets criteria for participation in low to moderate risk exercise based on the American College of Sports Medicine guideline (ACSM)
Exclusion Criteria
* Are pregnant or nursing
* Are unwilling or unable to follow protocol requirements
* Have any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study
* Have metastatic breast cancer
* Have orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise
ALL
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Ellis Levine
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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NCI-2018-00455
Identifier Type: REGISTRY
Identifier Source: secondary_id
I 32816
Identifier Type: OTHER
Identifier Source: secondary_id
I 32816
Identifier Type: -
Identifier Source: org_study_id
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