Randomized Study Comparing Two Strategies of Physical Activity in Long-term Breast and Colon Cancer Survivors and Their Impact on Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Improvement in cancer related-fatigue
研究概览
简要总结
Breast and colon cancer survivors with no evidence of disease, who score less than 45 in the PREDICT questionnaire for fatigue, will be randomized to a supervised strength program versus a supervised resistance program. The primary objective is improvement of cancer-related fatigue.
详细描述
Patients should have finalized their oncological treatment in the previous 5 years. The sample size (32 patients) was calculated to improve the perception of fatigue score from an anticipated initial 38 to a post-intervention 48.
The control arm consist of supervised strength training in two sessions per week with non-supervised international recommendations for aerobic exercise. The experimental arm will consist of supervised strength + resistance training in two sessions per week.
After evaluating the weekly physical activity through accelerometer, body composition through DEXA and the cardiorespiratory fitness through CPET, participants will initiate the training according to a randomized assignment.
Secondary objectives include:
- cardiorespiratory fitness,
- quality of life;
- adherence to the training program;
- adherence to international recommendations,
- body composition,
- employment status
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of breast or colon cancer
- •no evidence of disease
- •end of treatment in the last five years
- •able to understand the questionnaire PERFORM
- •able to manage the accelerometer
排除标准
- •mobility limitation
- •treatment with beta-blockers
- •exclusion criteria for CPET
研究组 & 干预措施
A: Supervised combined training
INTERVENTION: Two supervised 75 min-vigorous aerobic training & strength training
干预措施: Vigorous aerobic training (Behavioral)
B: Supervised strength training
ACTIVE COMPARATOR: Two supervised 45-minute sessions of strength training & Participants will be advised to comply with international recommendations of physical activity (150 min pf MVPA)
干预措施: Vigorous aerobic training (Behavioral)
结局指标
主要结局
Improvement in cancer related-fatigue
时间窗: 4 months
次要结局
- Changes in quality of life(4 months)
- adherence to the program(4 months)
- Changes in body composition(4 months)
- Changes in cardiorespiratory fitness(4 months)
- adherence to international recommendations(4 months)
- Employment status(4 months)
研究者
Ana Ruiz-Casado
MD PhD
Puerta de Hierro University Hospital