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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.

Publication ,  Journal Article
Jones, LW; Douglas, PS; Eves, ND; Marcom, PK; Kraus, WE; Herndon, JE; Inman, BA; Allen, JD; Peppercorn, J
Published in: BMC Cancer
October 6, 2010

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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Published In

BMC Cancer

DOI

EISSN

1471-2407

Publication Date

October 6, 2010

Volume

10

Start / End Page

531

Location

England

Related Subject Headings

  • Walking
  • Treatment Outcome
  • Research Design
  • Randomized Controlled Trials as Topic
  • Quality of Life
  • Postmenopause
  • Oxygen Consumption
  • Oxygen
  • Oncology & Carcinogenesis
  • Humans
 

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Jones, L. W., Douglas, P. S., Eves, N. D., Marcom, P. K., Kraus, W. E., Herndon, J. E., … Peppercorn, J. (2010). 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. BMC Cancer, 10, 531. https://doi.org/10.1186/1471-2407-10-531
Jones, Lee W., Pamela S. Douglas, Neil D. Eves, P Kelly Marcom, William E. Kraus, James E. Herndon, Brant A. Inman, Jason D. Allen, and Jeffrey Peppercorn. “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.BMC Cancer 10 (October 6, 2010): 531. https://doi.org/10.1186/1471-2407-10-531.
Journal cover image

Published In

BMC Cancer

DOI

EISSN

1471-2407

Publication Date

October 6, 2010

Volume

10

Start / End Page

531

Location

England

Related Subject Headings

  • Walking
  • Treatment Outcome
  • Research Design
  • Randomized Controlled Trials as Topic
  • Quality of Life
  • Postmenopause
  • Oxygen Consumption
  • Oxygen
  • Oncology & Carcinogenesis
  • Humans