Effect of a Short Program (8 Week) of Increased Physical Activity on Quality of Life of Sedentary Women With Previous Breast Cancer. A Prospective Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- quality of life
研究概览
简要总结
This is a prospective randomized controlled trial in which patients with previous breast cancer will be randomized into two treatment arms:
- Control Group of Usual Physical Activity
- Intervention Group of Increased Physical Activity
No specific intervention will be performed In the patients randomized in the control group.
Patients randomized in the Intervention group will receive a program of increased physical activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks. At the same time patients of this group will receive an 8-week recreational program of brisk walking/running (3 times a week).
All the patients enrolled in this trial will receive a pedometer device (Garmin Vìvofit) able to count the number of steps, determine a daily goal of steps, determine the covered distance (in Km), determine daily caloric consumption, and determine the movements during sleep.
详细描述
In this prospective randomized controlled trial patients with previous breast cancer will be randomized into two treatment arms:
- Control Group of Usual Physical Activity
- Intervention Group of Increased Physical Activity
No specific intervention will be performed In the patients randomized in the control group.
Patients randomized in the Intervention Group will receive a program of increased physical activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks. At the same time patients of this group will receive an 8-week recreational program of brisk walking/running (3 times a week).
All the patients enrolled in this trial will receive a pedometer device (Garmin Vìvofit) able to count the number of steps, determine a daily goal of steps, determine the covered distance (in Km), determine daily caloric consumption, and determine the movements during sleep.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with personal history of breast cancer AND
- •Written informed consent AND
- •Willing to be randomized to either group AND
- •Age 18-70 years
- •Treatment (surgery, chemotherapy, radiotherapy, trastuzumab) completed since at least 6 months and up to 3 years (endocrine therapy allowed)
- •Non regular exercisers (≤150 minutes per week of moderate-intense exercise).
排除标准
- •Diabetes or other insulin metabolic impairment
- •General contraindications to regular physical activity participation
- •Inability to ambulate
- •Plan to relocate far from the study site
- •Presence of any severe medical condition such that the patient is not expected to adhere at the planned study protocol
研究组 & 干预措施
Control Group
Usual Physical Activity
Intervention Group
8-week increased physical activity program
干预措施: Increased Physical Activity (Behavioral)
结局指标
主要结局
quality of life
时间窗: 8 weeks
questionnaire
次要结局
- self-report questionaire of principal side effects of medical treatments(8 weeks)
- patients' self-reported perceptions of their cognitive abilities(8 weeks)
- subjective response to a specific traumatic event(8 weeks)
- body weight(8 weeks)
- sleep(8 weeks)
- insulin(8 weeks)
- immune function (as determined by Th17 e T regulators)(8 weeks)
- IGF-1(8 weeks)
- Leptin(8 weeks)
- C Reactive Protein(8 weeks)