A Pilot Study of Physical Activity Intervention in African American Men After Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Intervention effectiveness as measured by change in accelerometer measured physical activity
研究概览
简要总结
The purpose of this pilot study is to evaluate the feasibility of recruiting African American prostate cancer survivors to a 12 week physical activity intervention study of three arms (aerobics, resistance training, and usual care) through physician referral and community advertisement strategies. In addition, the investigators will investigate the acceptance rate of the intervention and gather preliminary results on the effect of exercise on African American men's urinary and sexual functions. These data can then be used to refine the intervention and its implementation model, and to inform the submission of a larger grant to the National Institutes of Health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Speaks English
- •African American
- •Radical prostatectomy for treatment of prostate cancer within the past 12 months
- •Cleared by physician to safely participate in a physical exercise program
排除标准
- •Does not speak English
- •Non-African American
- •Previously undergone radiation treatment to the pelvis
- •Previously undergone major pelvic surgery
- •Known urethral stricture, colostomy, or inability to urinate requiring chronic urinary catheter
研究组 & 干预措施
Arm 1: Aerobics
-
Complete baseline questionnaires either online or on paper
-
Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
-
Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
-
Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
-
Require physical evaluation and orientation to the WellAware gym
-
12 week walking program at the WellAware Center
-
required to check in with gym staff to check attendance
-
advised to walk at own pace for 3 days per week
-
15 minutes per day for the first 2 weeks
-
30 minutes per day for the next 2 weeks
-
50 minutes or more for remaining weeks
干预措施: Questionnaire regarding behavior/lifestyle changes since diagnosis (Other)
Arm 1: Aerobics
-
Complete baseline questionnaires either online or on paper
-
Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
-
Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
-
Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
-
Require physical evaluation and orientation to the WellAware gym
-
12 week walking program at the WellAware Center
-
required to check in with gym staff to check attendance
-
advised to walk at own pace for 3 days per week
-
15 minutes per day for the first 2 weeks
-
30 minutes per day for the next 2 weeks
-
50 minutes or more for remaining weeks
干预措施: 12 week Walking Program (Other)
Arm 1: Aerobics
-
Complete baseline questionnaires either online or on paper
-
Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
-
Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
-
Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
-
Require physical evaluation and orientation to the WellAware gym
-
12 week walking program at the WellAware Center
-
required to check in with gym staff to check attendance
-
advised to walk at own pace for 3 days per week
-
15 minutes per day for the first 2 weeks
-
30 minutes per day for the next 2 weeks
-
50 minutes or more for remaining weeks
干预措施: Godin Leisure-Time Exercise Questionnaire (GLTEQ) (Other)
Arm 1: Aerobics
-
Complete baseline questionnaires either online or on paper
-
Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
-
Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
-
Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
-
Require physical evaluation and orientation to the WellAware gym
-
12 week walking program at the WellAware Center
-
required to check in with gym staff to check attendance
-
advised to walk at own pace for 3 days per week
-
15 minutes per day for the first 2 weeks
-
30 minutes per day for the next 2 weeks
-
50 minutes or more for remaining weeks
干预措施: Community Health Activities Model Program for Seniors (CHAMPS) (Other)
Arm 1: Aerobics
-
Complete baseline questionnaires either online or on paper
-
Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
-
Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
-
Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
-
Require physical evaluation and orientation to the WellAware gym
-
12 week walking program at the WellAware Center
-
required to check in with gym staff to check attendance
-
advised to walk at own pace for 3 days per week
-
15 minutes per day for the first 2 weeks
-
30 minutes per day for the next 2 weeks
-
50 minutes or more for remaining weeks
干预措施: Lifetime Total Physical Activity Questionnaire (Other)
Arm 1: Aerobics
-
Complete baseline questionnaires either online or on paper
-
Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
-
Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
-
Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
-
Require physical evaluation and orientation to the WellAware gym
-
12 week walking program at the WellAware Center
-
required to check in with gym staff to check attendance
-
advised to walk at own pace for 3 days per week
-
15 minutes per day for the first 2 weeks
-
30 minutes per day for the next 2 weeks
-
50 minutes or more for remaining weeks
干预措施: Expanded Prostate Cancer Index Composite (EPIC) (Other)
Arm 1: Aerobics
-
Complete baseline questionnaires either online or on paper
-
Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
-
Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
-
Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
-
Require physical evaluation and orientation to the WellAware gym
-
12 week walking program at the WellAware Center
-
required to check in with gym staff to check attendance
-
advised to walk at own pace for 3 days per week
-
15 minutes per day for the first 2 weeks
-
30 minutes per day for the next 2 weeks
-
50 minutes or more for remaining weeks
干预措施: International Physical Activity Prevalence Study Environmental Module (Other)
Arm 2: Resistance training
-
Complete baseline questionnaires either online or on paper
-
Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
-
Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
-
Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
-
Require physical evaluation and orientation to the WellAware gym
-
12 week weight lifting program at WellAware Center
-
exercise physiologists will work with each patient to develop a custom routine
-
exercise load will start at 60% of one-repetition maximum and progress from 8 to 12 repetitions
-
2-4 sets of repetition exercises will be performed to target upper & lower muscle groups
-
resistance load will be added by 5 pounds when patients can complete more than 12 repetitions
干预措施: Community Health Activities Model Program for Seniors (CHAMPS) (Other)
Arm 2: Resistance training
-
Complete baseline questionnaires either online or on paper
-
Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
-
Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
-
Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
-
Require physical evaluation and orientation to the WellAware gym
-
12 week weight lifting program at WellAware Center
-
exercise physiologists will work with each patient to develop a custom routine
-
exercise load will start at 60% of one-repetition maximum and progress from 8 to 12 repetitions
-
2-4 sets of repetition exercises will be performed to target upper & lower muscle groups
-
resistance load will be added by 5 pounds when patients can complete more than 12 repetitions
干预措施: Lifetime Total Physical Activity Questionnaire (Other)
Arm 2: Resistance training
-
Complete baseline questionnaires either online or on paper
-
Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
-
Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
-
Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
-
Require physical evaluation and orientation to the WellAware gym
-
12 week weight lifting program at WellAware Center
-
exercise physiologists will work with each patient to develop a custom routine
-
exercise load will start at 60% of one-repetition maximum and progress from 8 to 12 repetitions
-
2-4 sets of repetition exercises will be performed to target upper & lower muscle groups
-
resistance load will be added by 5 pounds when patients can complete more than 12 repetitions
干预措施: Expanded Prostate Cancer Index Composite (EPIC) (Other)
Arm 2: Resistance training
-
Complete baseline questionnaires either online or on paper
-
Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
-
Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
-
Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
-
Require physical evaluation and orientation to the WellAware gym
-
12 week weight lifting program at WellAware Center
-
exercise physiologists will work with each patient to develop a custom routine
-
exercise load will start at 60% of one-repetition maximum and progress from 8 to 12 repetitions
-
2-4 sets of repetition exercises will be performed to target upper & lower muscle groups
-
resistance load will be added by 5 pounds when patients can complete more than 12 repetitions
干预措施: International Physical Activity Prevalence Study Environmental Module (Other)
Arm 2: Resistance training
-
Complete baseline questionnaires either online or on paper
-
Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
-
Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
-
Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
-
Require physical evaluation and orientation to the WellAware gym
-
12 week weight lifting program at WellAware Center
-
exercise physiologists will work with each patient to develop a custom routine
-
exercise load will start at 60% of one-repetition maximum and progress from 8 to 12 repetitions
-
2-4 sets of repetition exercises will be performed to target upper & lower muscle groups
-
resistance load will be added by 5 pounds when patients can complete more than 12 repetitions
干预措施: Godin Leisure-Time Exercise Questionnaire (GLTEQ) (Other)
Arm 2: Resistance training
-
Complete baseline questionnaires either online or on paper
-
Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
-
Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
-
Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
-
Require physical evaluation and orientation to the WellAware gym
-
12 week weight lifting program at WellAware Center
-
exercise physiologists will work with each patient to develop a custom routine
-
exercise load will start at 60% of one-repetition maximum and progress from 8 to 12 repetitions
-
2-4 sets of repetition exercises will be performed to target upper & lower muscle groups
-
resistance load will be added by 5 pounds when patients can complete more than 12 repetitions
干预措施: Questionnaire regarding behavior/lifestyle changes since diagnosis (Other)
Arm 2: Resistance training
-
Complete baseline questionnaires either online or on paper
-
Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
-
Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
-
Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
-
Require physical evaluation and orientation to the WellAware gym
-
12 week weight lifting program at WellAware Center
-
exercise physiologists will work with each patient to develop a custom routine
-
exercise load will start at 60% of one-repetition maximum and progress from 8 to 12 repetitions
-
2-4 sets of repetition exercises will be performed to target upper & lower muscle groups
-
resistance load will be added by 5 pounds when patients can complete more than 12 repetitions
干预措施: 12 week Resistance Training Program (Other)
Arm 3: Usual care
- Complete baseline questionnaires either online or on paper
- Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
- Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
- Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
干预措施: Community Health Activities Model Program for Seniors (CHAMPS) (Other)
Arm 3: Usual care
- Complete baseline questionnaires either online or on paper
- Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
- Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
- Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
干预措施: Lifetime Total Physical Activity Questionnaire (Other)
Arm 3: Usual care
- Complete baseline questionnaires either online or on paper
- Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
- Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
- Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
干预措施: Expanded Prostate Cancer Index Composite (EPIC) (Other)
Arm 3: Usual care
- Complete baseline questionnaires either online or on paper
- Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
- Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
- Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
干预措施: International Physical Activity Prevalence Study Environmental Module (Other)
Arm 3: Usual care
- Complete baseline questionnaires either online or on paper
- Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
- Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
- Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
干预措施: Godin Leisure-Time Exercise Questionnaire (GLTEQ) (Other)
Arm 3: Usual care
- Complete baseline questionnaires either online or on paper
- Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline
- Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks.
- Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
干预措施: Questionnaire regarding behavior/lifestyle changes since diagnosis (Other)
结局指标
主要结局
Intervention effectiveness as measured by change in accelerometer measured physical activity
时间窗: Completion of study (approximately 3.5 years)
Intervention effectiveness as measured by change in self-reported urinary/sexual function as measured by Expanded Prostate Cancer Index Composite (EPIC)
时间窗: Completion of study (approximately 3.5 years)
-Intervention effectiveness will be compared between the three arms by comparing the change in self-reported urinary and sexual function. Mixed effects regression will be used to account for the longitudinal design.
Recruitment rate comparisons between physician referral and community advertisement
时间窗: Completion of study (approximately 3.5 years)
Attrition rate in each arm
时间窗: Completion of study (approximately 3.5 years)
* Evaluate percentage of finished duration of walking in each session and percentage of total finished session in the aerobic exercise arm. * Evaluate the percentage of attended sessions in the resistance training arm
次要结局
未报告次要终点