Breast CancerHEATNCT04950010
High-intensity Exercise After Treatment
A study testing High-Intensity Interval Training and Moderate-Intensity Exercise in people with Breast Cancer and Breast Neoplasm Female, run by University of Nebraska at 1 site in United States.
Trial summary
This pilot study tests the feasibility and preliminary efficacy of an 8-week, 3-arm pilot exercise trial in which 45 breast cancer survivors will be randomized to high-intensity interval training (HIIT; n=15), moderate-intensity aerobic training (MOD; n=15), or Usual Care (UC; n=15). Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasm Female
- What is being tested?
- High-Intensity Interval Training and Moderate-Intensity Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 15 Jul 2022
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female (aged 19 or older)
- First, primary diagnosis of Stage I-IIIa breast cancer
- Hormone receptor positive (ER+ and/or PR+) diagnosis
- Human epidermal growth factor receptor 2 negative (HER2-) diagnosis
- Completed primary adjuvant treatment (i.e., surgery, chemotherapy, and/or radiation therapy)
- Currently prescribed an aromatase inhibitor
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- No evidence of possible cognitive impairment as assessed using the Telephone Interview of Cognitive Status (TICS-M; score >21)
- Sedentary except for casual lifestyle recreation. This is defined as self-reporting 20+ minutes of exercise physical activity on 2 or fewer days per week within the previous six months.
- Receive physician's clearance to participate in an exercise program
- Agree to be randomized
- Fully vaccinated for COVID-19 ≥2 weeks prior to participation
- Provide written informed consent to participate in study
Who cannot join
- Males.
- Stage 0 breast cancer diagnosis or metastatic disease
- Currently receiving chemotherapy or radiation therapy for any cancer
- Scheduled to receive breast surgery (e.g., mastectomy, reconstructive surgery) during the study period
- Second cancer diagnosis (excluding non-invasive skin cancers; including breast cancer recurrence)
- Self-report an 20+ minutes of exercise physical activity on 3+ days per week for the previous 6 months
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- Pregnant or plan to become pregnant during study period.
- Is not cleared to participate in exercise by a physician.
- Enrolled in another physical activity program
- Unable to cycle on a stationary bike
- Unwilling to complete study requirements
- History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal
- Clinically significant TICS-M score (<21) during baseline procedures
- Not fully vaccinated for COVID-19
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Enhancing Cognitive and Cardiovascular Function in Breast Cancer Survivors Through High-intensity Interval Training
This pilot study tests the feasibility and preliminary efficacy of an 8-week, 3-arm pilot exercise trial in which 45 breast cancer survivors will be randomized to high-intensity interval training (HIIT; n=15), moderate-intensity aerobic training (MOD; n=15), or Usual Care (UC; n=15).
Read the detailed description
Aim 1: Determine the feasibility and acceptability of an 8-week high-intensity interval training (HIIT) program compared with a standard moderate-intensity aerobic training (MOD) program in 45 breast cancer survivors prescribed aromatase inhibitors.
Aim 2: Calculate effect sizes associated with the 8-week HIIT program, compared with MOD and Usual Care (UC), on cognitive and cardiovascular functions in 45 breast cancer survivors.
Eligible individuals will be women diagnosed with Stages I-IIIa breast cancer, have completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy), and currently prescribed an aromatase inhibitor. The specific aims are: 1) Determine the feasibility and acceptability of an 8-week high-intensity interval training (HIIT) program compared with a standard moderate-intensity (MOD) program; and 2) Calculate effect sizes associated with the 8-week HIIT program, compared with MOD and usual care (UC), on cognitive and cardiovascular functions. Cognitive function is operationalized as performance on executive function and working memory tasks. Cardiovascular function is operationalized as exercise capacity (VO2peak, heart rate recovery), resting function (heart rate, blood pressure), and cardiovascular structure/function (arterial stiffness, arterial wall thickness, endothelial function). Associations between change in cardiovascular outcomes and change in cognitive outcomes across the intervention period will also be explored.
- Conditions
- Breast Cancer, Breast Neoplasm Female
- Being tested
- High-Intensity Interval Training, Moderate-Intensity Exercise
- Keywords
- breast cancer, physical activity, cognitive function, exercise, cardiovascular function
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval TrainingBehavioural
HIIT is a type of training in which short periods of high-intensity anaerobic exercise (1-4 minutes at 80-95% of VO2peak) are alternated with less intense aerobic recovery periods (1-3 minutes at 50-60% VO2peak). Individually-tailored exercise prescriptions will be developed based upon each participant's baseline maximal graded exercise test (heart rate corresponding with %VO2 peak) and symptom limitation. Sessions will be progressive in nature such that the volume of exercise (i.e., number and intensity of intervals) increases across weeks. Intervals will progress from a heart rate corresponding with 75% VO2peak in Week 1 to 90-95% VO2peak in Weeks 5-8. Sessions will be ~30 minutes in length. Indoor cycling is the primary mode of exercise.
Moderate-Intensity ExerciseBehavioural
Individually-tailored exercise prescriptions will be developed based upon each participant's baseline maximal graded exercise test (heart rate corresponding with %VO2 peak) and symptom limitation. Sessions will be progressive in nature such that the volume of exercise increases across weeks. Indoor cycling is the primary mode of exercise. Sessions will include moderate-intensity cycling that progresses from a heart rate corresponding with 55-60% VO2peak for 30 minutes in Week 1 to 65-70% VO2peak for 45-50 minutes in Weeks 5-8.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Interval Training (HIIT) | Experimental | Breast cancer survivors randomized to HIIT will participate in a high-intensity interval training program for 8 weeks. Receives: Behavioral: High-Intensity Interval Training |
| Moderate-Intensity Exercise (MOD) | Active comparator | Breast cancer survivors randomized to MOD will participate in a moderate-intensity aerobic exercise program for 8 weeks. Receives: Behavioral: Moderate-Intensity Exercise |
| Usual Care (UC) | No intervention | Individuals randomized to UC will be instructed to continue standard cancer care and engage in habitual lifestyle behaviors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation Rate
Sample size / [1-(#ineligible/# exposed to recruitment)*(#exposed to recruitment)]
Measured: Baseline
Adherence to the exercise programs
average number of exercise sessions (out of 24) attended
Measured: post-intervention (Week 9)
Compliance of the exercise programs
average number of exercise sessions (out of 24) in which the prescribed exercise duration and intensity are achieved
Measured: post-intervention
Acceptability of the exercise programs
satisfaction with the exercise program as measured by a satisfaction survey. Survey uses a 5-point Likert-type scale. Satisfaction for each item is defined as reporting 4-5 on the scale (i.e., somewhat agree or completely agree).
Measured: post-intervention
Change in executive function processing
Change in completion time on Trails B task, with higher values indicating lower executive function.
Measured: Baseline, post-intervention (Week 9)
Change in cognitive flexibility
Change in reaction time on Task-switch task, with higher values indicating lower cognitive flexibility
Measured: Baseline, post-intervention (Week 9)
Change in spatial working memory reaction time
Change in reaction time on spatial working memory task, with faster reaction times indicating better spatial working memory
Measured: Baseline, post-intervention (Week 9)
Secondary outcomes (3)
Change in Cardiorespiratory Fitness
Change in Peak VO2 as measured by a modified Balke treadmill graded exercise test protocol.
Measured: Baseline, post-intervention (Week 9)
Carotid arterial wall thickness
will be estimated from vascular ultrasound and expressed as average and maximum mm
Measured: Baseline, post-intervention (Week 9)
Endothelial function
estimated from brachial artery flow mediated dilation and expressed as percent change in brachial artery diameter relative to baseline diameter
Measured: Baseline, post-intervention (Week 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start28 Mar 2022
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Why it stopped: Original PI moved to a new institution
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Diane Ehlers, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950010
- Sponsor's protocol ID
- 0439-21-FB
- Other IDs
- 1U54GM115458
- Acronym
- HEAT
- Status last verified
- Aug 2024
- First submitted
- 14 Jun 2021
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Although the final dataset will not include identifying information, there is still a possibility of deductive disclosure of identity. Therefore, data will not be shared via an NIH or approved public repository; however, we will share de-identified data as required for publication in scientific journals and with outside collaborators and scientists upon request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cognitive and Cardiovascular Function in Breast Cancer Survivors Through High-intensity Interval Training
- ClinicalTrials.gov ID
- NCT04950010
- Acronym / sponsor ID
- HEAT / 0439-21-FB
- Conditions
- Breast Cancer, Breast Neoplasm Female
- Keywords
- breast cancer, physical activity, cognitive function, exercise, cardiovascular function
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Original PI moved to a new institution
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 2 Jul 2021 (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.
This pilot study tests the feasibility and preliminary efficacy of an 8-week, 3-arm pilot exercise trial in which 45 breast cancer survivors will be randomized to high-intensity interval training (HIIT; n=15), moderate-intensity aerobic training (MOD; n=15), or Usual Care (UC; n=15).
Detailed description
Aim 1: Determine the feasibility and acceptability of an 8-week high-intensity interval training (HIIT) program compared with a standard moderate-intensity aerobic training (MOD) program in 45 breast cancer survivors prescribed aromatase inhibitors.
Aim 2: Calculate effect sizes associated with the 8-week HIIT program, compared with MOD and Usual Care (UC), on cognitive and cardiovascular functions in 45 breast cancer survivors.
Eligible individuals will be women diagnosed with Stages I-IIIa breast cancer, have completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy), and currently prescribed an aromatase inhibitor. The specific aims are: 1) Determine the feasibility and acceptability of an 8-week high-intensity interval training (HIIT) program compared with a standard moderate-intensity (MOD) program; and 2) Calculate effect sizes associated with the 8-week HIIT program, compared with MOD and usual care (UC), on cognitive and cardiovascular functions. Cognitive function is operationalized as performance on executive function and working memory tasks. Cardiovascular function is operationalized as exercise capacity (VO2peak, heart rate recovery), resting function (heart rate, blood pressure), and cardiovascular structure/function (arterial stiffness, arterial wall thickness, endothelial function). Associations between change in cardiovascular outcomes and change in cognitive outcomes across the intervention period will also be explored.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Training (HIIT) | Experimental | Behavioral: High-Intensity Interval TrainingBreast cancer survivors randomized to HIIT will participate in a high-intensity interval training program for 8 weeks. |
| Moderate-Intensity Exercise (MOD) | Active comparator | Behavioral: Moderate-Intensity ExerciseBreast cancer survivors randomized to MOD will participate in a moderate-intensity aerobic exercise program for 8 weeks. |
| Usual Care (UC) | No intervention | –Individuals randomized to UC will be instructed to continue standard cancer care and engage in habitual lifestyle behaviors. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult female (aged 19 or older)
- First, primary diagnosis of Stage I-IIIa breast cancer
- Hormone receptor positive (ER+ and/or PR+) diagnosis
- Human epidermal growth factor receptor 2 negative (HER2-) diagnosis
- Completed primary adjuvant treatment (i.e., surgery, chemotherapy, and/or radiation therapy)
Key exclusion criteria (14 listed)
- Males.
- Stage 0 breast cancer diagnosis or metastatic disease
- Currently receiving chemotherapy or radiation therapy for any cancer
- Scheduled to receive breast surgery (e.g., mastectomy, reconstructive surgery) during the study period
- Second cancer diagnosis (excluding non-invasive skin cancers; including breast cancer recurrence)
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 |
|---|---|---|
| High-Intensity Interval TrainingHIIT is a type of training in which short periods of high-intensity anaerobic exercise (1-4 minutes at 80-95% of VO2peak) are alternated with less intense aerobic recovery periods (1-3 minutes at 50-60% VO2peak). Individually-tailored exercise prescriptions will be developed based upon each participant's baseline maximal graded exercise test (heart rate corresponding with %VO2 peak) and symptom limitation. Sessions will be progressive in nature such that the volume of exercise (i.e., number and intensity of intervals) increases across weeks. Intervals will progress from a heart rate corresponding with 75% VO2peak in Week 1 to 90-95% VO2peak in Weeks 5-8. Sessions will be ~30 minutes in length. Indoor cycling is the primary mode of exercise. | Behavioural | High-Intensity Interval Training (HIIT) |
| Moderate-Intensity ExerciseIndividually-tailored exercise prescriptions will be developed based upon each participant's baseline maximal graded exercise test (heart rate corresponding with %VO2 peak) and symptom limitation. Sessions will be progressive in nature such that the volume of exercise increases across weeks. Indoor cycling is the primary mode of exercise. Sessions will include moderate-intensity cycling that progresses from a heart rate corresponding with 55-60% VO2peak for 30 minutes in Week 1 to 65-70% VO2peak for 45-50 minutes in Weeks 5-8. | Behavioural | Moderate-Intensity Exercise (MOD) |
Primary outcome
Participation Rate
Time frame: Baseline
Sample size / [1-(#ineligible/# exposed to recruitment)*(#exposed to recruitment)]
Adherence to the exercise programs
Time frame: post-intervention (Week 9)
average number of exercise sessions (out of 24) attended
Compliance of the exercise programs
Time frame: post-intervention
average number of exercise sessions (out of 24) in which the prescribed exercise duration and intensity are achieved
Acceptability of the exercise programs
Time frame: post-intervention
satisfaction with the exercise program as measured by a satisfaction survey. Survey uses a 5-point Likert-type scale. Satisfaction for each item is defined as reporting 4-5 on the scale (i.e., somewhat agree or completely agree).
Change in executive function processing
Time frame: Baseline, post-intervention (Week 9)
Change in completion time on Trails B task, with higher values indicating lower executive function.
Change in cognitive flexibility
Time frame: Baseline, post-intervention (Week 9)
Change in reaction time on Task-switch task, with higher values indicating lower cognitive flexibility
Change in spatial working memory reaction time
Time frame: Baseline, post-intervention (Week 9)
Change in reaction time on spatial working memory task, with faster reaction times indicating better spatial working memory
3 secondary outcomes
Change in Cardiorespiratory Fitness
Time frame: Baseline, post-intervention (Week 9)
Carotid arterial wall thickness
Time frame: Baseline, post-intervention (Week 9)
Endothelial function
Time frame: Baseline, post-intervention (Week 9)
Results and safety
The study was stopped early (reason given: Original PI moved to a new institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: Yes. Although the final dataset will not include identifying information, there is still a possibility of deductive disclosure of identity. Therefore, data will not be shared via an NIH or approved public repository; however, we will share de-identified data as required for publication in scientific journals and with outside collaborators and scientists upon request.
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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.
Diane Ehlers, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training and Moderate-Intensity Exercise in people with Breast Cancer and Breast Neoplasm Female, run by University of Nebraska 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 12 inclusion and 14 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: stopped early, as of the sponsor's last update on 5 Sep 2024. 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 was stopped early (reason given: Original PI moved to a new institution). Results are not available in the source record.
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?
Participation Rate (time frame: Baseline). The study lists 7 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 5 Sep 2024.