An interventional study of 3 month physical activity intervention in Breast Cancer, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to female participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-03-08.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Supportive care
The purpose of the study is to examine the benefits of physical activity for breast cancer survivors related to muscle strength, tiredness, and sleep quality. Also, the study will determine the potential role of inflammation in these benefits.
Our previous research has shown that increases in physical activity can improve the health and well-being of breast cancer survivors. The current study will determine whether the physical activity increases are adequate for improved health by measuring physical activity (accelerometer and self-report), muscle strength, fatigue, and sleep. Moreover, few studies have examined cytokine changes in cancer survivors after participation in a physical activity behavior change intervention with a mechanistic focus on cytokines which may influence the muscle strength, fatigue, and sleep response to the intervention.
Seventy-four female, breast cancer survivors are being recruited within a 50-miles radius of Springfield, IL. Participants will be in the study for approximately 5 months. Participants will be asked to complete a questionnaire at the beginning of the study and 3 months later. A blood sample will be drawn to determine serum cytokine levels.
Volunteers will be randomly assigned to 1 of 2 study groups. The intervention group will participate in a 3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands.
This randomized controlled trial includes the following study aims:
Study aim 1: The intervention group will be compared with the control group to examine the change in physical activity, muscle strength, fatigue, and sleep dysfunction before and after participation in a physical activity intervention.
Study aim 2: To investigate mechanisms that may underlie the effects of the physical activity intervention on muscle strength, fatigue, and sleep, we will compare the intervention group with the control group in terms of changes in cytokine markers of inflammation and evaluate whether such changes are consistent with and may mediate changes in muscle strength, fatigue, and sleep dysfunction.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 49 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Alabama at Birmingham is the lead sponsor of 1,394 studies on the registry; 282 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
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Exclusion Criteria:
no physical activity intervention
3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands
Behavioral: 3 month physical activity intervention
3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands
Also known as: exercise
physical activity
The intervention group will be compared with the control group to examine the change in physical activity, before and after participation in a physical activity intervention. Participants are in the study for approximately 5 months. Assessments will be conducted at baseline, and following the 3 month exercise intervention.
Time frame: baseline and 3 months
muscle strength
The intervention group will be compared with the control group to examine the change in muscle strength before and after participation in a physical activity intervention.
Time frame: baseline and 3 months
fatigue
The intervention group will be compared with the control group to examine the change in fatigue before and after participation in a physical activity intervention.
Time frame: baseline and 3 months
sleep dysfunction
The intervention group will be compared with the control group to examine the change in sleep dysfunction before and after participation in a physical activity intervention.
Time frame: baseline and 3 months
inflammatory markers (serum cytokine levels)
The study will also examine whether changes in inflammatory markers mediate improvements in the outcome measures of muscle strength, fatigue, and sleep dysfunction. Blood samples with no potential for extraction of DNA will be collected.
Time frame: baseline and 3 months
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham