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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.

dc.contributor.author Allen, JD
dc.contributor.author Douglas, Pamela Susan
dc.contributor.author Eves, ND
dc.contributor.author Herndon, James Emmett II
dc.contributor.author Inman, BA
dc.contributor.author Jones, LW
dc.contributor.author Kraus, William Erle
dc.contributor.author Marcom, PK
dc.contributor.author Peppercorn, J
dc.coverage.spatial England
dc.date.accessioned 2011-06-21T17:29:38Z
dc.date.issued 2010-10-06
dc.identifier http://www.ncbi.nlm.nih.gov/pubmed/20925920
dc.identifier 1471-2407-10-531
dc.identifier.uri http://hdl.handle.net/10161/4358
dc.description.abstract 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.
dc.language eng
dc.language.iso en_US
dc.relation.ispartof BMC Cancer
dc.relation.isversionof 10.1186/1471-2407-10-531
dc.relation.isreplacedby 10161/16117
dc.relation.isreplacedby http://hdl.handle.net/10161/16117
dc.subject Biomarkers
dc.subject Breast Neoplasms
dc.subject Exercise
dc.subject Exercise Therapy
dc.subject Female
dc.subject Humans
dc.subject Oxygen
dc.subject Oxygen Consumption
dc.subject Postmenopause
dc.subject Quality of Life
dc.subject Randomized Controlled Trials as Topic
dc.subject Research Design
dc.subject Treatment Outcome
dc.subject Walking
dc.title 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.
dc.title.alternative
dc.type Journal article
dc.description.version Version of Record
duke.date.pubdate 2010-10-6
duke.description.issue
duke.description.volume 10
dc.relation.journal Bmc Cancer
pubs.author-url http://www.ncbi.nlm.nih.gov/pubmed/20925920
pubs.begin-page 531
pubs.organisational-group Basic Science Departments
pubs.organisational-group Biomedical Engineering
pubs.organisational-group Biostatistics & Bioinformatics
pubs.organisational-group Clinical Science Departments
pubs.organisational-group Duke
pubs.organisational-group Duke Cancer Institute
pubs.organisational-group Duke Clinical Research Institute
pubs.organisational-group Duke Molecular Physiology Institute
pubs.organisational-group Faculty
pubs.organisational-group Institutes and Centers
pubs.organisational-group Medicine
pubs.organisational-group Medicine, Cardiology
pubs.organisational-group Medicine, Medical Oncology
pubs.organisational-group Pratt School of Engineering
pubs.organisational-group Psychiatry & Behavioral Sciences
pubs.organisational-group Psychiatry & Behavioral Sciences, Behavioral Medicine
pubs.organisational-group School of Medicine
pubs.organisational-group School of Nursing
pubs.organisational-group School of Nursing - Secondary Group
pubs.organisational-group Surgery
pubs.organisational-group Surgery, Urology
pubs.publication-status Published online
pubs.volume 10
dc.identifier.eissn 1471-2407


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