Study on Physical Activity's Relationship With Cancer and Cognition
NCT ID: NCT03980626
Last Updated: 2024-09-05
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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COMPLETED
NA
31 participants
INTERVENTIONAL
2019-09-30
2021-07-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Walking Intervention
Walking participants will engage in the 3-times weekly walking program for 12 weeks.
Walking
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.
Usual Care
Usual care participants will be offered two personalized exercise sessions with a trained exercise specialist after all post-intervention data have been collected.
No interventions assigned to this group
Interventions
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Walking
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Post-menopausal at time of diagnosis
* First, primary diagnosis of Stage I-IIIa breast cancer
* Completed treatment 3-24 months prior to study start
* Available to attend exercise sessions 3 times weekly for 12 weeks
* No scheduled travel \>7 consecutive days during the intervention
* Agree to be randomized
* Willingness to wear, charge, and sync Fitbit
* English reading and speaking
* Physician's clearance to exercise
* Provide written informed consent
Exclusion Criteria
* Pre- or peri-menopausal at the time of diagnosis
* Stage 0 or metastatic disease
* Currently receiving chemotherapy or radiation therapy
* More than 24 months post-treatment
* Scheduled to receive breast surgery
* Second cancer diagnosis (excluding non-invasive skin cancers)
* Self-report an average of ≥60 minutes of moderate to vigorous physical activities (MVPA) per week for the previous 6 months
* Not cleared to exercise by a physician
* Not available to attend 3 times weekly exercise sessions for 12 weeks
* Out of town travel scheduled for \>1 week during the intervention
* Unwilling to complete baseline assessments
* Unwilling to be randomized to the exercise or control group
* Unwilling to wear, charge, and sync the Fitbit during the study period
* Unable to read and speak in English
* Unwilling to provide written informed consent to participate
* Cognitive impairment prior to baseline assessment
* History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal
FEMALE
No
Sponsors
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University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Diane K 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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References
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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.
Other Identifiers
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0091-19-FB
Identifier Type: -
Identifier Source: org_study_id
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