Breast CancerNCT05913713
HIIT Following Breast Cancer Chemotherapy
A study testing 12-week Intervention Period and 12-week Observation Period in people with Breast Cancer, run by University of Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 12-week Intervention Period and 12-week Observation Period
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2024to 20 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- do not meet inclusion criteria
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Cardiovascular Physiology Laboratory, University of Florida
Gainesville, Florida, 32611
About this study
Official title: High Intensity Interval Training: Optimizing Exercise Therapy to Mitigate Cardiovascular Disease Risk Following Breast Cancer Chemotherapy
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.
- Conditions
- Breast Cancer
- Being tested
- 12-week Intervention Period, 12-week Observation Period
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week Intervention PeriodBehavioural
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 PeriodBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training (HIIT) | Experimental | Supervised home-based high-intensity interval training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks. Receives: Behavioral: 12-week Intervention Period; Behavioral: 12-week Observation Period |
| Moderate Intensity Continuous Training (MICT) | Experimental | Supervised home-based moderate-intensity continuous training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks. Receives: Behavioral: 12-week Intervention Period; Behavioral: 12-week Observation Period |
| Usual Care (UC) | Other | 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). Receives: Behavioral: 12-week Intervention Period; Behavioral: 12-week Observation Period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brachial FMD
Flow-mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD will be determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia.
Measured: Baseline, Following a 12-week intervention period, Following a 12-week observation period
Change in cardiac function (global longitudinal strain)
Global longitudinal strain is a marker of acute subclinical cardiotoxicity and is recommended for monitoring cancer patients at risk of cancer therapy-related cardiac dysfunction.
Measured: Baseline, Following a 12-week intervention period, Following a 12-week observation period
Percent completed vs. planned exercise frequency
The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise sessions/week.
Measured: Throughout the 12 weeks of supervised home-based exercise training
Percent completed vs. planned exercise duration
The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise min/session.
Measured: Throughout the 12 weeks of supervised home-based exercise training
Percent completed vs. planned exercise intensity
The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise intensity/session.
Measured: Throughout the 12 weeks of supervised home-based exercise training
Number of participants who experience adverse events as defined by most recent CTCAE throughout the exercise intervention
To evaluate safety plans are in place for determination and monitoring of adverse events according to the most recent National Cancer Institute Common Terminology Criteria for Adverse Events. Classification for seriousness, expectedness, severity and relationship to study intervention will be based on the NIH provided definitions.
Measured: Throughout the 12 weeks of supervised home-based exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start7 Mar 2024
- Primary completion20 May 2026
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Demetra Christou, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913713
- Sponsor's protocol ID
- IRB202300460 -N
- Other IDs
- 1R21AG078995-01A1
- Status last verified
- Aug 2026
- First submitted
- 13 Jun 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval Training: Optimizing Exercise Therapy to Mitigate Cardiovascular Disease Risk Following Breast Cancer Chemotherapy
- ClinicalTrials.gov ID
- NCT05913713
- Acronym / sponsor ID
- IRB202300460 -N
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training (HIIT) | Experimental | Behavioral: 12-week Intervention Period, Behavioral: 12-week Observation PeriodSupervised home-based high-intensity interval training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks. |
| Moderate Intensity Continuous Training (MICT) | Experimental | Behavioral: 12-week Intervention Period, Behavioral: 12-week Observation PeriodSupervised home-based moderate-intensity continuous training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks. |
| Usual Care (UC) | Other | Behavioral: 12-week Intervention Period, Behavioral: 12-week Observation PeriodResearch 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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- do not meet inclusion criteria
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-week Intervention PeriodResearch 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. | Behavioural | High Intensity Interval Training (HIIT), Moderate Intensity Continuous Training (MICT), Usual Care (UC) |
| 12-week Observation PeriodAfter 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. | Behavioural | High Intensity Interval Training (HIIT), Moderate Intensity Continuous Training (MICT), Usual Care (UC) |
Primary outcome
Change in brachial FMD
Time frame: Baseline, Following a 12-week intervention period, Following a 12-week observation period
Flow-mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD will be determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia.
Change in cardiac function (global longitudinal strain)
Time frame: Baseline, Following a 12-week intervention period, Following a 12-week observation period
Global longitudinal strain is a marker of acute subclinical cardiotoxicity and is recommended for monitoring cancer patients at risk of cancer therapy-related cardiac dysfunction.
Percent completed vs. planned exercise frequency
Time frame: Throughout the 12 weeks of supervised home-based exercise training
The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise sessions/week.
Percent completed vs. planned exercise duration
Time frame: Throughout the 12 weeks of supervised home-based exercise training
The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise min/session.
Percent completed vs. planned exercise intensity
Time frame: Throughout the 12 weeks of supervised home-based exercise training
The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise intensity/session.
Number of participants who experience adverse events as defined by most recent CTCAE throughout the exercise intervention
Time frame: Throughout the 12 weeks of supervised home-based exercise training
To evaluate safety plans are in place for determination and monitoring of adverse events according to the most recent National Cancer Institute Common Terminology Criteria for Adverse Events. Classification for seriousness, expectedness, severity and relationship to study intervention will be based on the NIH provided definitions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Demetra Christou, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week Intervention Period and 12-week Observation Period in people with Breast Cancer, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brachial FMD (time frame: Baseline, Following a 12-week intervention period, Following a 12-week observation period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.