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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
7
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.
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.
University of Nebraska Medical Center
Omaha, Nebraska, United States
Participation Rate
Sample size / \[1-(#ineligible/# exposed to recruitment)\*(#exposed to recruitment)\]
Time frame: Baseline
Adherence to the exercise programs
average number of exercise sessions (out of 24) attended
Time frame: 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
Time frame: 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).
Time frame: post-intervention
Change in executive function processing
Change in completion time on Trails B task, with higher values indicating lower executive function.
Time frame: Baseline, post-intervention (Week 9)
Change in cognitive flexibility
Change in reaction time on Task-switch task, with higher values indicating lower cognitive flexibility
Time frame: 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
Time frame: Baseline, post-intervention (Week 9)
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Change in Cardiorespiratory Fitness
Change in Peak VO2 as measured by a modified Balke treadmill graded exercise test protocol.
Time frame: Baseline, post-intervention (Week 9)
Carotid arterial wall thickness
will be estimated from vascular ultrasound and expressed as average and maximum mm
Time frame: 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
Time frame: Baseline, post-intervention (Week 9)