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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TERMINATED
NA
7 participants
INTERVENTIONAL
2022-03-28
2022-07-15
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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High-Intensity Interval Training (HIIT)
Breast cancer survivors randomized to HIIT will participate in a high-intensity interval training program for 8 weeks.
High-Intensity Interval Training
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 Exercise (MOD)
Breast cancer survivors randomized to MOD will participate in a moderate-intensity aerobic exercise program for 8 weeks.
Moderate-Intensity Exercise
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.
Usual Care (UC)
Individuals randomized to UC will be instructed to continue standard cancer care and engage in habitual lifestyle behaviors.
No interventions assigned to this group
Interventions
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High-Intensity Interval Training
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 Exercise
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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
19 Years
FEMALE
No
Sponsors
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National Institute of General Medical Sciences (NIGMS)
NIH
University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Diane Ehlers, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Locations
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University of Nebraska Medical Center
Omaha, Nebraska, United States
Countries
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Other Identifiers
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0439-21-FB
Identifier Type: -
Identifier Source: org_study_id
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