University of Nebraska Medical Center
Omaha, Nebraska, 68198-8440, United States
NCT Number: NCT03980626
This pilot study tests the effects of aerobic exercise training on cognitive function in breast cancer survivors (BCS). Participants will be randomized to a 12-week walking intervention or usual care. Walking participants will attend small group sessions led by an exercise specialist 3 times weekly. Usual care participants will complete baseline and post-testing and be offered two sessions with an exercise specialist. All participants will complete a fitness test, electrophysiology, and patient-reported outcomes at baseline and post-intervention. A subset of participants will also be invited to undergo magnetic resonance imaging (MRI). The investigators will generate preliminary data on clinical and biological correlates of exercise and cognition, including treatment protocol, cardiorespiratory fitness, brain structure and function, and cancer-related fatigue.
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Interventional
Not applicable
Omaha, Nebraska, 68198-8440, United States
Aim 1: This pilot study tests the effects of aerobic exercise training on cognitive function in breast cancer survivors (BCS). To test aim 1, the investigators will randomize up to forty post-menopausal BCS (3-24 months post-treatment) to a 12-week walking intervention (n=20) or usual care (n=20). Walking participants will attend small group (n=3-5 BCS) sessions led by an exercise specialist 3 times weekly. Usual care participants will complete baseline and post-testing and be offered two sessions with an exercise specialist after all data have been collected. Aim 1 measures include accelerometry, neurocognitive testing, and patient-reported outcomes at baseline and post-intervention.
Aim 2: The investigators will generate preliminary data on clinical and biological correlates of exercise and cognition, including treatment protocol, cardiorespiratory fitness, brain structure and function, and cancer-related fatigue. To test aim 2, all participants will complete a fitness test, electrophysiology, and patient-reported outcomes at baseline and post-intervention. A subset of participants will also be invited to undergo magnetic resonance imaging (MRI).
Data will be analyzed using descriptive statistics and analysis of covariance, and effect sizes expressed as standard mean difference will be calculated.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The exercise intervention is designed to improve cardiorespiratory fitness, a known correlate of cognition and brain health, and follows the American College of Sports Medicine exercise guidelines for cancer survivors. Participants will engage in small group, moderate-to-vigorous intensity walking sessions three times weekly. Sessions will begin with a warm-up and end with a cool down and be progressive in nature. Volume of exercise will increase across weeks such that participants will progress from 15-20 minutes of walking to 40-45 minutes by week 8, and from 40-55% of their estimated heart rate reserve (HRR) to 65% of their HRR by week 9. All sessions will be led by trained exercise specialists to ensure close monitoring of participant safety. Participants will wear heart rate monitors and be asked to rate their perceived exertion to ensure they are exercising within the prescribed range. Modifications to each participant's exercise prescription will be made as needed.
Other names: Aerobic Exercise Training
Time frame: Baseline, Week 12
A comprehensive neurocognitive battery will be administered to measure executive function as defined by a latent factor of manifest indicators of performance on executive function tasks.
Time frame: Baseline, Week 12
A comprehensive neurocognitive battery will be administered to measure working memory as defined by a latent factor of manifest indicators of performance on working memory tasks.
Time frame: Baseline, Week 12
A comprehensive neurocognitive battery will be administered to measure processing speed as defined by a latent factor of manifest indicators of processing speed tasks.
Time frame: Baseline, Week 12
Magnetic Resonance Imaging (MRI) will be used to measure regional volume.
Time frame: Baseline, Week 12
Diffusion tensor imaging (DTI) will be used to measure white matter structural integrity (fractional anisotropy, diffusivity).
Time frame: Baseline, Week 12
Resting state function MRI will be used to measure resting state functional connectivity (patterns of blood oxygen level dependent (BOLD) activity within seed regions of interest compared to whole brain activity).
Time frame: Baseline, Week 12
N2pc amplitude is a neural measure of spacial attention during the Visual Search Task (measured in microvolts) to be measured with electroencephalography (Visual Search Task, Change Detections Task).
Time frame: Baseline, Week 12
Fitness will be measured with a submaximal exercise test. The Naughton Protocol for submaximal graded exercise tests will be used to examine change in cardiovascular fitness.
Time frame: Baseline, Week 12
The Functional Assessment in Chronic Illness Therapy (FACIT) - Fatigue Scale will be used to measure cancer-related fatigue. Scores range from 0-52, with higher scores indicating less cancer-related fatigue.
Time frame: Baseline, Week 12
Objective activity behavior (average minutes per day) will be measured using actigraphy.
University of Nebraska
Other
Study on Physical Activity's Relationship With Cancer and Cognition: A Pilot Randomized Trial
Acronym: SPARCC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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