Hormones and Physical Exercise (HOPE) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Change from Baseline in Arthralgia Severity
研究概览
简要总结
The investigators propose to examine 121 postmenopausal women diagnosed with hormone-receptor positive breast cancer who have been taking aromatase inhibitors (AI) for at least 6 months and are experiencing at least mild arthralgia originating during AI treatment, the yearlong effect of exercise vs. attention control (health education), and on toxic side effects of AI.
详细描述
The investigators propose to examine, in 121 postmenopausal breast cancer survivors who have been taking an AI for at least 2 months and are currently experiencing at least mild arthralgia associated with AI use, the effect of a randomized controlled exercise intervention vs. attention control (health education) on severity of arthralgia, endocrine-related Quality of Life(QOL), Bone Mineral Density(BMD), and mediators/mechanisms influencing the effect of exercise on arthralgia severity. Women will be randomized to a year long exercise program or attention control group. Women randomized to exercise will participate in 150 min/wk of aerobic exercise and a twice-weekly strength training program. The investigators will conduct baseline, six-, and 12-month clinic visits, as well as a 3- and 9-month mailing to evaluate the effect of the intervention on study outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women (defined as the surgical or natural absence of menstrual cycles for at least 1 year prior to breast cancer diagnosis).
- •75 years or younger
- •AJCC Stages I-IIIC Breast Cancer
- •Taking an AI for at least 2 months
- •Currently experiencing at least mild arthralgia (= or > 3 on the BPI) associated with AI use
- •Physically able to exercise and physician consent to start an exercise program
- •Sedentary activity pattern (< 90 mins/week of moderate-to-vigorous intensity sports activity) within the past year and low fitness level
- •No more than one strength training session per week within the past year
- •Agrees to be randomly assigned to either exercise or attention control
- •Gives informed consent to participate in all study activities
- •Able to come for baseline, 6-, and 12-month clinic visits and strength training sessions (6-month intervention study - able to come for baseline, 6-month clinic visits and strength training sessions).
- •Mentally competent
排除标准
- •Lymphedema with self reported 'flare up' in the past 4 months
研究组 & 干预措施
Exercise
The exercise intervention group will receive social, behavioral support and research staff contact time to encourage them to increase their activity level to include twice weekly strength-training sessions and 150 min of walking/week (e.g., three 50-min walking sessions or five 30-min walking sessions) over 12 months.
干预措施: Exercise (Behavioral)
Attention Control (Health Education)
The Attention Control Group will be provided written information that emphasizes the importance of a healthy lifestyle. Participants will be encouraged to follow the NCI and ACS physical activity guidelines. This procedure was followed in our exercise trials, with no increase in physical activity levels observed at follow-up among women in the usual care group. Attention Control participants will also receive frequent contacts throughout the 12 month intervention. Each month, women randomized to attention control will be contacted by phone to discuss a health education topic of interest
干预措施: Attention Control (Health Education) (Behavioral)
结局指标
主要结局
Change from Baseline in Arthralgia Severity
时间窗: 12 months
Measured using the Brief Pain Inventory (BPI). Subjects are asked to rate pain by circling a number from 0-10 that describes pain at its "worst", "least", and "average" with 0 being no pain and 10 being "pain as bad as you can imagine".
Change from Baseline in Arthralgia Severity
时间窗: 6 months
Measured using the Brief Pain Inventory (BPI). Subjects are asked to rate pain by circling a number from 0-10 that describes pain at its "worst", "least", and "average" with 0 being no pain and 10 being "pain as bad as you can imagine".
次要结局
未报告次要终点