Rationale and design of the Exercise Intensity Trial (EXCITE): A randomized trial comparing the effects of moderate versus moderate to high-intensity aerobic training in women with operable breast cancer.

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Jones, Lee W

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Douglas, Pamela S

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Eves, Neil D

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Marcom, P Kelly

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Kraus, William E

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Herndon, James E

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Inman, Brant A

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Allen, Jason D

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Peppercorn, Jeffrey

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England

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2011-06-21T17:29:38Z

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2010-10-06

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BACKGROUND: The Exercise Intensity Trial (EXcITe) is a randomized trial to compare the efficacy of supervised moderate-intensity aerobic training to moderate to high-intensity aerobic training, relative to attention control, on aerobic capacity, physiologic mechanisms, patient-reported outcomes, and biomarkers in women with operable breast cancer following the completion of definitive adjuvant therapy. METHODS/DESIGN: Using a single-center, randomized design, 174 postmenopausal women (58 patients/study arm) with histologically confirmed, operable breast cancer presenting to Duke University Medical Center (DUMC) will be enrolled in this trial following completion of primary therapy (including surgery, radiation therapy, and chemotherapy). After baseline assessments, eligible participants will be randomized to one of two supervised aerobic training interventions (moderate-intensity or moderate/high-intensity aerobic training) or an attention-control group (progressive stretching). The aerobic training interventions will include 150 mins.wk⁻¹ of supervised treadmill walking per week at an intensity of 60%-70% (moderate-intensity) or 60% to 100% (moderate to high-intensity) of the individually determined peak oxygen consumption (VO₂peak) between 20-45 minutes/session for 16 weeks. The progressive stretching program will be consistent with the exercise interventions in terms of program length (16 weeks), social interaction (participants will receive one-on-one instruction), and duration (20-45 mins/session). The primary study endpoint is VO₂peak, as measured by an incremental cardiopulmonary exercise test. Secondary endpoints include physiologic determinants that govern VO₂peak, patient-reported outcomes, and biomarkers associated with breast cancer recurrence/mortality. All endpoints will be assessed at baseline and after the intervention (16 weeks). DISCUSSION: EXCITE is designed to investigate the intensity of aerobic training required to induce optimal improvements in VO₂peak and other pertinent outcomes in women who have completed definitive adjuvant therapy for operable breast cancer. Overall, this trial will inform and refine exercise guidelines to optimize recovery in breast and other cancer survivors following the completion of primary cytotoxic therapy. TRIAL REGISTRATION: NCT01186367.

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Version of Record

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http://www.ncbi.nlm.nih.gov/pubmed/20925920

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1471-2407-10-531

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1471-2407

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https://hdl.handle.net/10161/4358

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eng

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en_US

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Springer Science and Business Media LLC

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BMC Cancer

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10.1186/1471-2407-10-531

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Bmc Cancer

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Biomarkers

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Breast Neoplasms

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Exercise

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Exercise Therapy

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Female

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Humans

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Oxygen

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Oxygen Consumption

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Postmenopause

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Quality of Life

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Randomized Controlled Trials as Topic

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Research Design

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Treatment Outcome

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Walking

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Rationale and design of the Exercise Intensity Trial (EXCITE): A randomized trial comparing the effects of moderate versus moderate to high-intensity aerobic training in women with operable breast cancer.

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dc.type

Journal article

duke.contributor.orcid

Douglas, Pamela S|0000-0001-9876-4049

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Marcom, P Kelly|0000-0001-5302-6368

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Kraus, William E|0000-0003-1930-9684

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Inman, Brant A|0000-0002-6060-4485

duke.date.pubdate

2010-10-6

duke.description.issue
duke.description.volume

10

pubs.author-url

http://www.ncbi.nlm.nih.gov/pubmed/20925920

pubs.begin-page

531

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Basic Science Departments

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Biomedical Engineering

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Biostatistics & Bioinformatics

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Clinical Science Departments

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Duke

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Duke Cancer Institute

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Duke Clinical Research Institute

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Duke Molecular Physiology Institute

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Faculty

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Institutes and Centers

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Medicine

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Medicine, Cardiology

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Medicine, Medical Oncology

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Pratt School of Engineering

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Psychiatry & Behavioral Sciences

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Psychiatry & Behavioral Sciences, Behavioral Medicine

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School of Medicine

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School of Nursing

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School of Nursing - Secondary Group

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Surgery

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Surgery, Urology

pubs.publication-status

Published online

pubs.volume

10

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