Ignite Creation Date:
2024-05-06 @ 2:53 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02152462
Status:
COMPLETED
Last Update Posted:
2020-02-10
First Post:
2014-03-31
Brief Title:
Exergaming Intervention and Breast Cancer Biomarkers in Black Women
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
Exergaming Intervention and Breast Cancer Biomarkers in Black Women
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POWER
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 overweightobese women to Wii Fit exercise n50 or the control arm n50 Women in the Wii Fit exercise group will come to the Georgetown community-based exercise facility 3 dayswk 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 minswk 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 minweek 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
Detailed Description:
1 Purpose of project one or two sentences To examine the feasibility and acceptability of an exergaming intervention in a community-based setting and to explore the effects of exergaming on cardiovascular fitness body mass index and percent body fat in Black women who are sedentary and overweight or obese
2 Study design for example hypothesis research questions standard and experimental proceduresdrugsdevices or equipment etc
Overview This is a 6 month two-arm randomized clinical trial using comparing exergaming to a control group The investigators will randomize Black sedentary overweightobese women to Wii Fit exercise n50 or the control arm n50 Women in the Wii Fit exercise group will come to the Georgetown community-based exercise facility 3 dayswk 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 minswk 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 minweek 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
Exercise Intervention Participants in the Wii Fit exergaming group will have a goal of 150 minwk 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 maximal oxygen consumption VO2max Given the expected VO2max values for this population the investigators project that the Wii Fit videogames must elevate energy expenditure to 3-4 times resting metabolic rate to achieve the desired HR responses As summarized above previous studies have shown that such an elevation in energy expenditure can be expected from these activities Wii Fit stations with a variety of active games will be available to participants at the Georgetown University Community Based Office Participants will be instructed by the exercise physiologist on how to achieve the required HR The training will consist of 3 dayswk of supervised Wii Fit physical activity Exercise duration will increase gradually from 75 to 150 minwk by wk 477 Thereafter women will maintain 150 minwk of moderate-intensity physical activity Participants will complete daily exercise diaries recording the type and duration of physical activity and HR
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
Diet Participants in both groups will be instructed to maintain their diet constant throughout the study Wii Fit intervention participants will be weighed at every session and those losing more weight than could be accounted for by their exercise will be counseled to return to their caloric intake at the start of the study
Rationale and justification for study ie historical background investigators personal experience pertinent medical literature etc Several risk factors have been identified that increase breast cancer risk some of which are non-modifiable factors eg age family history and race and some of which are modifiable eg physical activity body weight dietary habits and alcohol intake However only within the last 10 years have cancer organizations started to recommend physical activity as a preventive measure for breast cancer The American Cancer Society ACS and the International Agency for Research on Cancer of the World Health Organization now both recommend regular physical activity as a strategy for women to reduce their risk of developing breast cancer Specific recommendations for breast cancer prevention which initially focused on diet are now focused on maintaining a healthy weight throughout life by balancing caloric intake while increasing caloric expenditure via increased physical activity levels and losing weight if overweight or obese Obesity itself is a significant public health problem and is associated with increased postmenopausal breast cancer incidence and mortality This research proposal will assess a novel method to improve physical activity in African American women who are generally less physically active and more overweight and obese than women of most other racial and ethnic groups
Treatment Plan
The participants in the Wii Fit exergaming group will be encouraged to meet and then maintain a goal of 150 minwk of moderate intensity exercise for 6 months Goals per individual will be based on their baseline data Exercise duration will increase gradually from 75 minwk at week 1 to 150 minwk by week 4 Thereafter women will maintain 150 minwk of moderate-intensity physical activity The training will consist of 3 dayswk of supervised physical activity using Nintendo Wii Fit active videogames
Participants will exercise at a HR equal to 45-65 of their VO2max Given the expected VO2max values for this population the investigators project that the Wii Fit videogames will elevate energy expenditure to 3-4 times resting metabolic rate to achieve the desired HR responses As summarized above previous studies have shown that such an elevation in energy expenditure can be expected from these activities Participants will be instructed to monitor their physical activity in order to assist with their perceived behavioral control and increase self-efficacy towards meeting their goals
During aerobic exercise sessions participants will wear Polar heart rate monitors to determine exercise intensity and will be given instruction by the exercise physiologist on how achieve the required HR In addition participants will complete daily exercise diaries to record the type and duration of physical activity and exercise HR Because many women may not have access to gym memberships or be able to afford expensive exercise equipment the investigators address this environmental barrier by establishing Wii Fit stations with a variety of active games available to participants at the Community Based Office
Exergames selected for use during the exercise sessions will be chosen based on energy expenditure data Those active videogames that have been shown to achieve energy expenditure levels above those necessary to achieve 60 HRmax in the investigators specific study population will be selected For example active videogames tested in published studies such as Wii Fit boxing and Dance Dance Revolution have been found to achieve physical activity levels of moderate intensity 30-60 METs which meet American College of Sports Medicine guidelines for health and fitness Graves et al 2008 for example found physical activity levels to reach 68 of maximal heart rate HRmax using the Wii Fit which also meets ACSM aerobic fitness recommendations 60 HRmax
2 Study design for example hypothesis research questions standard and experimental proceduresdrugsdevices or equipment etc
Overview This is a 6 month two-arm randomized clinical trial using comparing exergaming to a control group The investigators will randomize Black sedentary overweightobese women to Wii Fit exercise n50 or the control arm n50 Women in the Wii Fit exercise group will come to the Georgetown community-based exercise facility 3 dayswk 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 minswk 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 minweek 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
Exercise Intervention Participants in the Wii Fit exergaming group will have a goal of 150 minwk 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 maximal oxygen consumption VO2max Given the expected VO2max values for this population the investigators project that the Wii Fit videogames must elevate energy expenditure to 3-4 times resting metabolic rate to achieve the desired HR responses As summarized above previous studies have shown that such an elevation in energy expenditure can be expected from these activities Wii Fit stations with a variety of active games will be available to participants at the Georgetown University Community Based Office Participants will be instructed by the exercise physiologist on how to achieve the required HR The training will consist of 3 dayswk of supervised Wii Fit physical activity Exercise duration will increase gradually from 75 to 150 minwk by wk 477 Thereafter women will maintain 150 minwk of moderate-intensity physical activity Participants will complete daily exercise diaries recording the type and duration of physical activity and HR
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
Diet Participants in both groups will be instructed to maintain their diet constant throughout the study Wii Fit intervention participants will be weighed at every session and those losing more weight than could be accounted for by their exercise will be counseled to return to their caloric intake at the start of the study
Rationale and justification for study ie historical background investigators personal experience pertinent medical literature etc Several risk factors have been identified that increase breast cancer risk some of which are non-modifiable factors eg age family history and race and some of which are modifiable eg physical activity body weight dietary habits and alcohol intake However only within the last 10 years have cancer organizations started to recommend physical activity as a preventive measure for breast cancer The American Cancer Society ACS and the International Agency for Research on Cancer of the World Health Organization now both recommend regular physical activity as a strategy for women to reduce their risk of developing breast cancer Specific recommendations for breast cancer prevention which initially focused on diet are now focused on maintaining a healthy weight throughout life by balancing caloric intake while increasing caloric expenditure via increased physical activity levels and losing weight if overweight or obese Obesity itself is a significant public health problem and is associated with increased postmenopausal breast cancer incidence and mortality This research proposal will assess a novel method to improve physical activity in African American women who are generally less physically active and more overweight and obese than women of most other racial and ethnic groups
Treatment Plan
The participants in the Wii Fit exergaming group will be encouraged to meet and then maintain a goal of 150 minwk of moderate intensity exercise for 6 months Goals per individual will be based on their baseline data Exercise duration will increase gradually from 75 minwk at week 1 to 150 minwk by week 4 Thereafter women will maintain 150 minwk of moderate-intensity physical activity The training will consist of 3 dayswk of supervised physical activity using Nintendo Wii Fit active videogames
Participants will exercise at a HR equal to 45-65 of their VO2max Given the expected VO2max values for this population the investigators project that the Wii Fit videogames will elevate energy expenditure to 3-4 times resting metabolic rate to achieve the desired HR responses As summarized above previous studies have shown that such an elevation in energy expenditure can be expected from these activities Participants will be instructed to monitor their physical activity in order to assist with their perceived behavioral control and increase self-efficacy towards meeting their goals
During aerobic exercise sessions participants will wear Polar heart rate monitors to determine exercise intensity and will be given instruction by the exercise physiologist on how achieve the required HR In addition participants will complete daily exercise diaries to record the type and duration of physical activity and exercise HR Because many women may not have access to gym memberships or be able to afford expensive exercise equipment the investigators address this environmental barrier by establishing Wii Fit stations with a variety of active games available to participants at the Community Based Office
Exergames selected for use during the exercise sessions will be chosen based on energy expenditure data Those active videogames that have been shown to achieve energy expenditure levels above those necessary to achieve 60 HRmax in the investigators specific study population will be selected For example active videogames tested in published studies such as Wii Fit boxing and Dance Dance Revolution have been found to achieve physical activity levels of moderate intensity 30-60 METs which meet American College of Sports Medicine guidelines for health and fitness Graves et al 2008 for example found physical activity levels to reach 68 of maximal heart rate HRmax using the Wii Fit which also meets ACSM aerobic fitness recommendations 60 HRmax
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None