Recruiting

Rowing

Sponsor:

University of Florida

Code:

NCT05848141

Conditions

Breast Cancer Survivors

Eligibility Criteria

Sex: Female

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Exercise training

Study Details

Brief summary:

There are more than 3.8 million breast cancer survivors in the United States and cancer survivors have a higher risk of cardiovascular disease (CVD) due to chemotherapy than adults without cancer. Cardiovascular rehabilitation can be an effective strategy to decrease the incidence of CVD and its risk factors in this population. The proposed study may help to examine the effect of a novel exercise intervention on cardiovascular rehabilitation in breast cancer survivors.

Conditions

Breast Cancer Survivors

Study ID

NCT05848141

Start date

Feb 26, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • diagnosis of primary invasive non-metastatic breast cancer, stages I-III
  • female based on biological sex
  • 40 to 80 years of age
  • completed breast cancer treatment 6 to 24 months prior to study enrollment. Adjuvant endocrine therapy for breast cancer (e.g., ovarian suppression, SERMs, SERDs, AIs), CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy and bisphosphonates are allowed within 6 months prior to study enrollment and during study participation
  • absence of contraindications to exercise or study participation
  • study clinician approval

Exclusion Criteria:

  • do not meet inclusion criteria
  • receiving or scheduled to receive treatment for breast cancer (i.e., chemotherapy, surgery, or radiation) during study participation is not allowed. Adjuvant endocrine therapy, CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy and bisphosphonates are allowed during study participation
  • lymphedema stage ≥ 2 prior to study enrolment
  • any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent)
  • current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)
  • consistent participation in ≥150 min/week of moderate-intensity rowing exercise training in previous 6 months

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Indoor Rowing

Research participants will be instructed how to use a Concept 2 RowErg and will be provided instruction on basic rowing skills for beginners. Exercise training will gradually progress to 50 min of moderate-intensity exercise, on 3 days per week, for 12 weeks.

no intervention: Usual Care

Research participants in this group will have the opportunity to complete the supervised indoor rowing program after completing their post-intervention assessments.

Interventions

Exercise training

This is a single site center-based supervised exercise intervention.

Primary outcome measure

  • Change in brachial FMD [ Time Frame: Baseline, Following 12 weeks of supervised exercise training ]
  • Change in global longitudinal strain [ Time Frame: Baseline, Following 12 weeks of supervised exercise training ]
  • % completed vs. planned exercise frequency [ Time Frame: Throughout the 12 weeks of supervised exercise training ]
  • % completed vs. planned exercise duration [ Time Frame: Throughout the 12 weeks of supervised exercise training ]
  • % completed vs. planned exercise intensity [ Time Frame: Throughout the 12 weeks of supervised exercise training ]
  • Number of participants who experience adverse event as defined by most recent CTCAE [ Time Frame: Throughout the 12 weeks of supervised exercise training ]

Central Contacts and Locations

Central contacts

Demetra Christou, PhD

352-294-1746ddchristou@ufl.edu

Locations

Integrative Cardiovasculal Physiology Laboratory, University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Demetra Christou, PhD

352-294-1746ddchristou@ufl.edu

More Information

Sponsor

University of Florida

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-08-27.