Different Modalities of Exercise for Physical Activity Promotion in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- The number of participants with an adverse event
研究概览
简要总结
The "CHOICE!" study is an exercise program following the recommendation of the American College of Sports Science for cancer patients. The aims of the intervention are to test the safety and feasibility of a structured program, letting patients choose the modality of delivery. Secondary endpoints include exercise health-related skills and quality of life. The program considers the preferences of exercise of cancer survivors, giving the possibility to choose the exercise modality (autonomous, with a personal trainer or group class). This program will be tested in different cancer populations with different study designs based on different patients cohort (i.e., RCT or single-arm).
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a confirmed cancer diagnosis;
- •≥ 8 weeks post-surgical procedure;
- •Medical clearance for participation provided by primary care physician or oncologist;
- •Informed consent signed;
排除标准
- •Age < 18 years old;
- •Pregnancy;
- •Inability to ambulate;
- •Contraindication to participation in a regular physical activity program;
- •Inability to understand the instructions for PA and/or Mini Mental State index <24;
- •Serious physical limitation and/or Karnofsky index <50.
结局指标
主要结局
The number of participants with an adverse event
时间窗: Change from baseline to 12 weeks
Adverse events will categorize according to the Common Terminology Criteria for Adverse Events (version 5.0)
The recruitment rate
时间窗: At 12 weeks
The number of patients randomized dividing the number of subjects considered eligible
The dropouts rate
时间窗: At 6 months
Defined as a participant who leaves the study for any reason prior to completing the 12-week (24 session) exercise program. All reasons for drop out will be reported.
The eligibility rate
时间窗: At 12 weeks
The number of patients considered eligible dividing the number of subjects who meet inclusion criteria
The adherence to exercise protocol
时间窗: At 12 weeks
Measured by the total number of exercise sessions attended
次要结局
- Cardiorespiratory fitness(Change from baseline cardiorespiratory fitness at 3 months)
- Body mass index(Change from baseline antrhopometric values at 3 months)
- Waist-hip ratio(Change from baseline antrhopometric values at 3 months)
- Upper limb flexibility(Change from baseline flexibility at 3 months)
- Upper limb muscle strength(Change from baseline muscle strength at 3 months)
- Physical activity level(Change from baseline physical activity level at 3 months)
- Enjoyment(Change from baseline enjoyment at 3 months)
- Quality of life (QoL)(Change from baseline quality of life at 3 months)
- Lower limb muscle strength(Change from baseline muscle strength at 3 months)
- Lower limb flexibility(Change from baseline flexibility at 3 months)
研究者
Alice Avancini
Investigator
Universita di Verona