Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
158 participants
INTERVENTIONAL
2024-03-07
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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High Intensity Interval Training (HIIT)
Supervised home-based high-intensity interval training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks.
12-week Intervention Period
Research participants will be randomly assigned to either high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), or the usual care (UC) group for a 12-week intervention period.
12-week Observation Period
After a 12-week intervention period (HIIT, MICT, or UC), research participants will have a 12-week observation period to assess the durability of two types of different exercises.
Moderate Intensity Continuous Training (MICT)
Supervised home-based moderate-intensity continuous training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks.
12-week Intervention Period
Research participants will be randomly assigned to either high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), or the usual care (UC) group for a 12-week intervention period.
12-week Observation Period
After a 12-week intervention period (HIIT, MICT, or UC), research participants will have a 12-week observation period to assess the durability of two types of different exercises.
Usual Care (UC)
Research participants will continue their habitual physical activity for the duration of the study. Once they complete the study, they will have the opportunity to perform supervised HIIT or MICT at home for 3 days/week for 12 weeks (research participants can choose either type of exercise).
12-week Intervention Period
Research participants will be randomly assigned to either high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), or the usual care (UC) group for a 12-week intervention period.
12-week Observation Period
After a 12-week intervention period (HIIT, MICT, or UC), research participants will have a 12-week observation period to assess the durability of two types of different exercises.
Interventions
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12-week Intervention Period
Research participants will be randomly assigned to either high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), or the usual care (UC) group for a 12-week intervention period.
12-week Observation Period
After a 12-week intervention period (HIIT, MICT, or UC), research participants will have a 12-week observation period to assess the durability of two types of different exercises.
Eligibility Criteria
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Inclusion Criteria
* 18 to 85 years of age
* diagnosis of primary, invasive, non-metastatic, stages I-III breast cancer
* completed chemotherapy for breast cancer (anthracycline, alkylating agent and/or taxane) more than 6 months but less than 18 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 of study enrollment and during study participation
* absence of contraindications to exercise or to participate in study
* study clinician approval
* scheduled to receive surgery or radiation therapy during the intervention period
* 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)
* lymphedema stage ≥2 prior to study enrollment
* are pregnant
* current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)
18 Years
85 Years
FEMALE
No
Sponsors
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National Institute on Aging (NIA)
NIH
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Demetra Christou, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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Integrative Cardiovascular Physiology Laboratory, University of Florida
Gainesville, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB202300460 -N
Identifier Type: -
Identifier Source: org_study_id
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