Impact of Hypertrophy-oriented Resistance Training on Muscle Mass and Quality of Life in Patients With Unresectable Pancreatic Cancer (HY-PANC): Study Protocol for a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Body Composition
研究概览
简要总结
To determine the efficacy of a 12-week supervised, hypertrophy-oriented strength training program in preserving skeletal muscle mass, physical function, and quality of life in patients with unresectable pancreatic cancer compared to standard care.
详细描述
Two-arm randomized controlled trial will recruit patients with unresectable pancreatic cancer undergoing chemotherapy. Participants will be randomized (1:1) to an Intervention Group (resistance training twice weekly) or a Control Group (standard care). The primary outcome is the change in total lean body mass (assessed by DXA) at week 12. Secondary outcomes include maximal strength, peak power, cardiorespiratory capacity, and patient-reported measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of locally advanced or metastatic unresectable pancreatic cancer
- •Undergoing chemotherapy or immunotherapy treatment
- •Age ≥ 18 years
- •ECOG score ≤ 2
排除标准
- •Any relative or absolute contraindication that prevents the performance of training or physical tests.
- •Diagnosis of other types of primary cancer
- •Inability to understand Spanish for proper comprehension of the informed consent and questionnaires
研究组 & 干预措施
Intervention Group
12 weeks of hypertrophy training in patients with advanced, unresectable PC receiving chemotherapy and/or immunotherapy
干预措施: supervised, hypertrophy-oriented strength training program (Other)
Control Group
Participants in the control group will receive standard oncological treatment. No restrictions on physical activity will be imposed. Furthermore, they will be offered the opportunity to follow the exercise program used in the intervention group if the expected benefits proposed in the study hypothesis are confirmed.
结局指标
主要结局
Body Composition
时间窗: Through study completion, an average of 1 year
The main objective of this study is to evaluate the effect on body composition (primarily lean mass) through 12 weeks of hypertrophy training in patients with advanced, non-operable pancreatic cancer undergoing treatment
次要结局
- VO2peak(Through study completion, an average of 1 year)
- Anxiety and Depression(Through study completion, an average of 1 year)
- Patient-reported outcome measures(Through study completion, an average of 1 year)
研究者
Lidia Brea Alejo
Director
Universidad Europea de Madrid