Women In Steady Exercise Research (WISER) Sister: Study design and methods

Kathryn H. Schmitz, Nancy I. Williams, Despina Kontos, Mindy S. Kurzer, Mitchell Schnall, Susan Domchek, Jill Stopfer, Mary Lou Galantino, Wei Ting Hwang, Knashawn Morales, Shandong Wu, Laura DiGiovanni, Domenick Salvatore, Desire' Fenderson, Jerene Good, Kathleen Sturgeon, Lorita Grant, Cathy J. Bryan, Jess Adelman

Research output: Contribution to journalArticlepeer-review

18 Scopus citations


Women at elevated risk for breast cancer are motivated to reduce their risk. Current approaches rely primarily on hormonal intervention. A preventive exercise intervention might address the same hormonal issues, yet have fewer serious side effects and less negative impact on quality of life as compared to prophylactic mastectomy. WISER Sister was a randomized controlled trial which examined effects of two doses of exercise training on endogenous sex hormone exposure, hormonally active breast tissue, and other breast cancer risk factors. Methods: Subjects for this single site trial were recruited from across the U.S., in collaboration with organizations that serve women at elevated risk, via emails, flyers, and letters. Eligibility criteria included age ≥. 18, eumenorrheic, and at elevated risk for breast cancer (e.g. BRCA1 or BRCA2 mutation and/or ≥. 18% lifetime risk according to prediction models). A 1:1:1 randomization scheme was used to allocate participants into: control, low dose (150. min/week), or high dose (300. min/week) home based treadmill exercise. Participants provided first morning urine samples daily for two menstrual cycles at study beginning and end for calculation of endogenous hormone exposure. In addition, women completed breast dynamic contrast enhanced magnetic resonance imaging, a fasting blood draw, a treadmill exercise test, and surveys at baseline and follow-up. Discussion: WISER Sister randomized 139 women, 122 of whom completed the study. The overall drop-out rate was 12%. Findings will be useful in understanding the potential for exercise to assist with reducing risk for breast cancer among women at elevated risk.

Original languageEnglish (US)
Pages (from-to)17-30
Number of pages14
JournalContemporary Clinical Trials
StatePublished - Mar 1 2015

Bibliographical note

Funding Information:
The authors wish to acknowledge the advocacy organizations that assisted with recruitment for this study, principally FORCE (Facing Our Risk of Cancer Empowered), the study participants, and the National Institutes of Health/National Cancer Institute for grant R01-CA131333 . This work was also supported by discounts for treadmills from Smooth Fitness, Inc, King of Prussia, PA. The project described was also supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health , through Grant UL1TR000003 . Several study investigators were supported by the Basser Center at the University of Pennsylvania's Abramson Cancer Center. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Publisher Copyright:
© 2015 Elsevier Inc.


  • BRCA mutation
  • Breast cancer
  • Exercise
  • MR imaging
  • Sex hormones


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