Breast Cancer Clinical Trial
— ACTOfficial title:
Activity & Cognition After Treatment (ACT) for Breast Cancer
NCT number | NCT02592070 |
Other study ID # | UIUC_IRB_15575 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | April 2016 |
Verified date | February 2020 |
Source | University of Illinois at Urbana-Champaign |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study addresses an important public health concern; impoverished cognitive function associated with treatment of breast cancer. Due to increased awareness of breast cancer combined with advances in medical care, there are over 2.8 million women living with a history of breast cancer in the U.S. alone. Chemotherapy and adjuvant therapy to remove cancerous tissue can result in deficits in attention, speed of processing, memory, and quality of life. Physical activity has been associated with a number of health benefits for breast cancer survivors including improvements in cognitive function. However, most of the literature is cross-sectional and it is unclear whether acute (single) bouts of physical activity affect cognition and, if they do, how long this effect lasts. This study will be the first, to the investigators' knowledge, to examine the effects of an acute bout of aerobic exercise on cognitive functioning in breast cancer survivors. Specifically, the investigators will determine the effects of a 30-minute moderate intensity aerobic exercise session (treadmill walking) on immediate and one hour follow up changes in measures of processing speed, memory, and executive function. Additionally, accelerometer cut-points for physical activity intensities in breast cancer survivors will be assessed. Finally, the investigators will examine the association of cardiorespiratory fitness and physical activity with changes in cognitive function. Findings from this study will allow researchers to determine whether any acute effects of exercise on cognition are retained over time and therefore have real meaning in the context of one's daily life.
Status | Completed |
Enrollment | 31 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 60 Years |
Eligibility |
Inclusion Criteria: - women between 30 and 60 years of age - diagnosis of breast cancer - no longer undergoing treatment - fluent in English - no history of dementia or organic brain syndrome - not currently pregnant - able to walk unassisted - no health reasons that would prevent ability to exercise - not currently enrolled in another exercise research study - reported trouble with memory/concentration - physician's consent Exclusion Criteria: - male - no diagnosis of breast cancer - outside of 30-60 years of age - currently undergoing treatment for breast cancer - inability to communicate in English - history of dementia or organic brain syndrome - pregnant - unable to walk unassisted - other health reasons that may prevent ability to exercise - enrolled in another exercise research study - no reported trouble with memory or concentration - non-consent of physician |
Country | Name | City | State |
---|---|---|---|
United States | Freer Hall, University of Illinois | Urbana | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Urbana-Champaign |
United States,
Baumann, F. T., Drosselmeyer, N., Leskaroski, A., Knicker, A., Krakowski-Roosen, H., Zopf, E. M., & Bloch, W. (2011). 12-week resistance training with breast cancer patients during chemotherapy: Effects on cognitive abilities. Breast Care, 6(2), 142-143.
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in cognitive function in breast cancer survivors immediately and one hour after an acute bout of exercise as assessed by a battery of cognitive functioning measures. | Participants will complete cognitive tasks, then exercise on a treadmill for 30 minutes before completing the same cognitive tasks again. Participants will then rest before completing the cognitive tasks one more time one hour after the end of the exercise period. | 1 year | |
Secondary | Change in relationship between exercise and cognitive function in breast cancer survivors as assessed by physical activity and fitness levels. | The investigators wish to explore if participants with higher levels of fitness and higher levels of physical activity exhibit different levels of cognitive functioning compared to their less fit and less active peers. | 1 year | |
Secondary | Physical activity guidelines in breast cancer survivors as assessed by graded exercise test. | Participants will wear an accelerometer while performing a graded maximal exercise test. The output of the accelerometer will be compared to that of the exercise test to determine what levels of activity line up with varying metabolic equivalents. This will help us determine physical activity guidelines for breast cancer survivors. | 60 minutes | |
Secondary | Change from baseline in anxiety levels after one bout of exercise as assessed by HADS questionnaire. | Participants will complete a short anxiety questionnaire before and after a 30 minute bout of aerobic exercise. The investigators will then compare the pre- and post- values to examine if any changes are present. | 30 minutes | |
Secondary | Change in relationship between exercise and cognitive function in breast cancer survivors as assessed by psychosocial questionnaires. | Participants will take home a short battery of questionnaires designed to assess psychosocial outcomes. They will bring it back one week later. The investigators will then explore if participants with higher levels of any of these variables exhibit higher levels of cognition and/or fitness compared to peers with lower levels of psychological constructs. | 1 year |
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