HIIT Following Breast Cancer Chemotherapy

NCT ID: NCT05913713

Last Updated: 2025-11-21

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-07

Study Completion Date

2026-05-31

Brief Summary

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Chemotherapy is an effective breast cancer treatment, which helped to increase the 5-year survival rate to approximately 95%. However, breast 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 and durability of a novel high-intensity interval training compared to moderate-intensity continuous training on cardiovascular rehabilitation in breast cancer survivors.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type EXPERIMENTAL

12-week Intervention Period

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

12-week Intervention Period

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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).

Group Type OTHER

12-week Intervention Period

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* female patients based on biological sex
* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Demetra Christou, PhD

Role: CONTACT

352-294-1746

Facility Contacts

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Demetra Christou, PhD

Role: primary

352-294-1746

Other Identifiers

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1R21AG078995-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB202300460 -N

Identifier Type: -

Identifier Source: org_study_id

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