Clinical trial · Interventional
Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)
NCT06322888CI-TRIAL-00097687recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer in women with dense breast tissue by studying changes that occur in breast tissue and blood as a result of participating in an exercise program. The names of the study groups in this study are: * Exercise Training Group * Waitlist Control Group
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Female | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Training Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Exercise Intervention
- description
- Participants will be randomized and will complete: * Baseline study visit with assessments, breast biopsy, and blood draw. * Exercise program for 12 weeks 3x weekly and exercise logs. Additional blood draw after first exercise session. * End of study visit with assessments, breast biopsy, and blood draw.
- interventionNames
- Behavioral: Exercise Training Program
- type
- NO_INTERVENTION
- label
- Arm B: Waitlist Control
- description
- Participants will be randomized and will complete: * Baseline study visit with assessments, breast biopsy, and blood draw. * End of study visit with assessments, breast biopsy, and blood draw. * Participants will be offered a complimentary 12-week exercise program after completing the study.
Primary outcomes (2)
- measure
- Change in Irisin in Exercise Group
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 18-59 * Heterogeneously dense/extremely dense (BIRADS 3 or 4) breast tissue on mammogram within the past 12 months * Physically inactive; engaging in \<60 minutes of moderate or vigorous intensity exercise per week, as assessed by Godin Leisure Time screener * Not pregnant or breastfeeding * English speaking and able to read English. Investigators are only enrolling English-speaking participants to this study at this time due to the fact that investigators currently only have English-speaking exercise trainers with the proper qualifications to conduct the exercise training * Written informed consent prior to any study-related procedures Exclusion Criteria: * Self-reported inability to walk 2 blocks (at any pace) * Prior history of breast cancer; prior DCIS is allowable as long as participant is not taking endocrine therapy and has at least 1 breast that has not been irradiated * On oral or implantable hormonal contraceptives, postmenopausal hormone replacement therapy, a selective estrogen receptor modulator or an aromatase inhibitor; Mirena or other IUD is acceptable * Consistent strength training in the past 3 months * Use of weightloss drugs * Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate exercise. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility * Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder)
References
Publications (0)
Data not yet available
No reference posted for this study.