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Exergaming Intervention and Breast Cancer Biomarkers in Black Women (POWER)

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ClinicalTrials.gov Identifier: NCT02152462
Recruitment Status : Active, not recruiting
First Posted : June 2, 2014
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Lucile Adams-Campbell, Georgetown University

Brief Summary:
Overview: This is a 6 month, two-arm randomized clinical trial using comparing exergaming to a control group. The investigators will randomize Black sedentary overweight/obese women to Wii Fit exercise (n=50) or the control arm (n=50). Women in the Wii Fit exercise group will come to the Georgetown community-based exercise facility 3 days/wk. The control group will be asked to maintain their current daily activities and not to exercise for the duration of the study. Based on the investigators previous findings that women who engage in 75-150 mins/wk of brisk walking had an 18% decreased risk of breast cancer, the investigators will target this level of activity in the investigators intervention arm. Also, this 150 min/week of physical activity meets the current recommendations of the American College of Sports Medicine (ACSM) and the US Department of Health and Human Services for healthy individuals and is in line with recommendation of the American Cancer Society (ACS) for cancer prevention.

Condition or disease Intervention/treatment Phase
Breast Cancer Obesity Other: Exergaming Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Exergaming Intervention and Breast Cancer Biomarkers in Black Women
Study Start Date : December 2012
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Exergaming
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.
Other: Exergaming
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Cardiovascular fitness (VO2 max) [ Time Frame: 6 months ]
    Cardiovascular fitness is measured using metabolic cart at baseline, 12 weeks, and 24 weeks.

  2. 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.



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Ages Eligible for Study:   40 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Black women
  • BMI ≥28 kg/m2 but ≤ 350 pounds of body weight
  • Aged 40-59 years
  • Sedentary (<60 min/wk exercise for past 6 months
  • Never been diagnosed with cancer
  • Ability to read and speak English and to provide meaningful consent
  • No physical limitations preventing them from exercising
  • Medical clearance by a health practitioner.

Exclusion Criteria:

  • History of cancer
  • Uncontrolled hypertension and medically treated diabetes
  • Current enrollment in another physical activity and/or dietary study or a diet/weight loss program
  • Pregnancy
  • Inability to consent to study participation and complete assessments
  • Telephone inaccessibility
  • Physical limitations to exercise inability to commit to the intervention schedule

Information from the National Library of Medicine

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


Locations
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United States, District of Columbia
Georgetown Lombardi Office of Minority Health & Health Disparities Research
Washington, District of Columbia, United States, 20003
Sponsors and Collaborators
Georgetown University
Investigators
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Principal Investigator: Lucile L Adams-Campbell, PhD Georgetown University

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Responsible Party: Lucile Adams-Campbell, Principal Investigator, Georgetown University
ClinicalTrials.gov Identifier: NCT02152462     History of Changes
Other Study ID Numbers: Pro00000116 Georgetown Lombard
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Keywords provided by Lucile Adams-Campbell, Georgetown University:
exergaming
breast cancer
African American women
obesity
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Benzocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents