Efficacy of a Supervised Exercise Program on Pain, Physical Function, and Quality of Life in Breast Cancer Survivors: Protocol for a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 325
- 试验地点
- 1
- 主要终点
- repeated measures ANOVA
研究概览
简要总结
The purpose of this project is to develop a randomized clinical trial to determine the efficacy of a supervised exercise program on pain, physical function and quality of life in female breast cancer survivors
详细描述
A randomized, double-blind, clinical trial will be conducted with 325 participants. The intervention group will receive a supervised exercise program for 12 weeks, while the control group will receive no intervention. Participants' pain, physical function and quality of life will be assessed at baseline, post-intervention and 12 weeks post-intervention.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women between 18 and 65 years of age,
- •women with oncologic treatment completed less than 3 months ago,
- •women without metastasis,
- •women without pathologies that contraindicate exercise,
- •women who have agreed to sign the informed consent form
排除标准
- •not attending scheduled sessions to instruct on the exercises to be performed, - being part of other studies,
- •undergoing another type of therapy
- •pregnancy patients.
研究组 & 干预措施
Grupo experimental
The participants will be recruited through the oncologists of the Hospital Universitario Torrecárdenas (Almería). The proposal will be carried out in the intervention group (group 1), while the control group (group 2) will undergo the conventional recommendations indicated for this type of patients.
干预措施: Exercise program (Other)
group control
The participants will be recruited through the oncologists of the Hospital Universitario Torrecárdenas (Almería). The proposal will be carried out in the intervention group (group 1), while the control group (group 2) will undergo the conventional recommendations indicated for this type of patients.
结局指标
主要结局
repeated measures ANOVA
时间窗: 12 weeks
the range of motion, tone and muscle strength of the group will be measured in 3 measures over the 12 weeks
次要结局
未报告次要终点