Exergaming Intervention and Breast Cancer Biomarkers in Black Women (POWER)
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|ClinicalTrials.gov Identifier: NCT02152462|
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : February 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Obesity||Other: Exergaming||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Exergaming Intervention and Breast Cancer Biomarkers in Black Women|
|Actual Study Start Date :||December 2012|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||December 2019|
Exercise Intervention: Participants in the Wii Fit exergaming group will have a goal of 150 min/wk of moderate intensity exercise for the last 5 mo of the 6 mo intervention. Heart rate (HR) monitors will quantify exercise intensity. Participants will exercise at a HR equal to 45-65% of their VO2max. Participants will be instructed by the exercise physiologist on how to achieve the required HR. The training will consist of 3 days/wk of supervised Wii Fit physical activity. Exercise duration will increase gradually from 75 to 150 min/wk by wk 477. Thereafter, women will maintain >150 min/wk of moderate-intensity physical activity. Participants will complete daily exercise diaries recording the type and duration of physical activity, and HR.
The participants in the Wii Fit exergaming group will be encouraged to meet and then maintain a goal of 150 min/wk of moderate intensity exercise for 6 months. Goals per individual will be based on their baseline data. Exercise duration will increase gradually from 75 min/wk at week 1 to 150 min/wk by week 4. Thereafter, women will maintain >150 min/wk of moderate-intensity physical activity. The training will consist of 3 days/wk of supervised physical activity using Nintendo Wii Fit active videogames.
No Intervention: Control
Control Group: After baseline testing the control group will be asked to maintain their current daily activities for the duration of the study. The control group will have the option to exercise at the Wii Fit stations following their completion of the study. They will receive the same measures as the exercise group.
- Biomarkers related to obesity and breast cancer risk [ Time Frame: 6 months ]Outcomes for plasma leptin, adiponectin, Insulin-like growth factor 1 (IGF-1), Insulin-like growth factor-binding protein 3 (IGFBP3), C-reactive protein (CRP), Interleukin 6 (IL-6), insulin, c-peptide, and Hb-A1c levels at baseline and 24 weeks.
- Cardiovascular fitness (VO2 max) [ Time Frame: 6 months ]Cardiovascular fitness is measured using metabolic cart at baseline, 12 weeks, and 24 weeks.
- Reported stress levels [ Time Frame: 6 months ]Reported stressed levels was assessed using the Perceived Stress Scale (PSS) at baseline, 12 weeks, and 24 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152462
|United States, District of Columbia|
|Georgetown Lombardi Office of Minority Health & Health Disparities Research|
|Washington, District of Columbia, United States, 20003|
|Principal Investigator:||Lucile L Adams-Campbell, PhD||Georgetown University|