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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walking Intervention | Experimental | Walking participants will engage in the 3-times weekly walking program for 12 weeks. |
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| Usual Care | No Intervention | Usual care participants will be offered two personalized exercise sessions with a trained exercise specialist after all post-intervention data have been collected. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walking | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Executive Function | 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. | Baseline, Week 12 |
| Change in Working Memory | 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. | Baseline, Week 12 |
| Change in Processing Speed | A comprehensive neurocognitive battery will be administered to measure processing speed as defined by a latent factor of manifest indicators of processing speed tasks. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Regional brain volume | Magnetic Resonance Imaging (MRI) will be used to measure regional volume. | Baseline, Week 12 |
| White matter structural integrity | Diffusion tensor imaging (DTI) will be used to measure white matter structural integrity (fractional anisotropy, diffusivity). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diane K Ehlers, PhD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-8440 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38900505 | Derived | Page LL, Fanning J, Phipps C, Berger A, Reed E, Ehlers D. Heart Rate Monitoring Among Breast Cancer Survivors: Quantitative Study of Device Agreement in a Community-Based Exercise Program. JMIR Cancer. 2024 Jun 20;10:e51210. doi: 10.2196/51210. |
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De-identified data will be available upon request as required by journal publishers during dissemination phase of the study.
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When summary data are published.
Individual participant data (IPD) will be provided as required by journals in which summary data are published.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D016138 | Walking |
| ID | Term |
|---|---|
| D008124 | Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Baseline, Week 12 |
| Resting state functional connectivity | 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). | Baseline, Week 12 |
| N2pc Amplitude | 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). | Baseline, Week 12 |
| Cardiorespiratory Fitness | 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. | Baseline, Week 12 |
| Cancer-related Fatigue | 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. | Baseline, Week 12 |
| Objective Activity Behavior | Objective activity behavior (average minutes per day) will be measured using actigraphy. | Baseline, Week 12 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |
| D015444 | Exercise |
| D009043 | Motor Activity |