University Medical Center Utrecht, Julius Center
Utrecht, 3508 GA, Netherlands
NCT Number: NCT00359060
Purpose of the SHAPE study is to examine the effects of an 1-year exercise programme on endogenous hormone levels associated with breast cancer among sedentary postmenopausal women and whether a decrease in intra-abdominal fat is associated with a lowering of these hormone levels.
Looking for future studies?
Notify Me50 year–69 year
Female
Interventional
Phase 3
Utrecht, 3508 GA, Netherlands
Physical activity has been associated with a decreased risk for breast cancer. The biological mechanism(s) underlying the association between physical activity and breast cancer is not clear. Most prominent hypothesis is that physical activity may protect against breast cancer through reduced lifetime exposure to endogenous hormones. Another hypothesis is that physical activity prevents overweight and abdominal adiposity.
In this intervention study, 189 sedentary postmenopausal women who are aged 50-69 years are randomly allocated to an intervention or a control group. The intervention consists of an 1-year moderate-to-vigorous intensity aerobic and strength training exercise programme. Participants allocated to the control group are requested to retain their habitual exercise pattern. Primary study parameters measured at baseline, at four months and at 12 months are: serum concentrations of endogenous estrogens, endogenous androgens, sex hormone binding globulin and insulin. Other study parameters include: amount of total and abdominal fat, weight, BMI, body fat distribution, physical fitness, blood pressure and lifestyle factors.
This study will contribute to the body of evidence relating physical activity and breast cancer risk and will provide insight into possible mechanisms through which physical activity might be associated with reduced risk of breast cancer in postmenopausal women.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
UMC Utrecht
Other
Physical Activity and Breast Cancer Risk in Postmenopausal Women: the SHAPE Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04000880
Adnexal Diseases, Behavior
Birmingham, Alabama, United States
View Trial DetailsNCT06340503
Behavior, Breast Cancer
Winston-Salem, North Carolina, United States
View Trial DetailsNCT06791018
Behavior, Breast Cancer
Edmonton, Alberta, Canada
View Trial DetailsNCT05297773
Behavior, Breast Cancer
Lisbon, Cruz-Quebrada, Portugal
View Trial Details