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

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.



Work Title Women In Steady Exercise Research (WISER) Sister: Study design and methods
Open Access
  1. Kathryn H. Schmitz
  2. Nancy I. Williams
  3. Despina Kontos
  4. Mindy S. Kurzer
  5. Mitchell Schnall
  6. Susan Domchek
  7. Jill Stopfer
  8. Mary Lou Galantino
  9. Wei Ting Hwang
  10. Knashawn Morales
  11. Shandong Wu
  12. Laura DiGiovanni
  13. Domenick Salvatore
  14. Desire' Fenderson
  15. Jerene Good
  16. Kathleen Sturgeon
  17. Lorita Grant
  18. Cathy J. Bryan
  19. Jess Adelman
License In Copyright (Rights Reserved)
Work Type Article
  1. Contemporary Clinical Trials
Publication Date March 1, 2015
Publisher Identifier (DOI)
  1. https://doi.org/10.1016/j.cct.2014.12.016
Deposited July 20, 2022




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Work History

Version 1

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