Blood Flow Restriction Exercise in the Perioperative Setting to Prevent the Loss of Muscle Mass in Patients With Pancreatic, Biliary Tract, and Liver Cancer - the PREV-Ex Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Skeletal muscle thickness
研究概览
简要总结
In patients with cancer, resistance training appears to be a safe and effective exercise modality to increase both lean muscle mass and strength, as well as attenuates cancer-related fatigue. It may serve as a feasible intervention in these patients to mitigate cachexia, especially if implemented before the onset of cancer cachexia or in a pre-cachectic state. This study is a multicenter randomized controlled trial that will compare a blood flow restricted resistance training intervention during the pre- (prehabilitation) and post-operative (rehabilitation) phase in patients with pancreatic, biliary tract and liver cancer, versus usual care on skeletal muscle and other health-related outcomes.
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
- Single (Outcomes Assessor)
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 resectable pancreatic cancer
- •Diagnosis of resectable biliary tract cancer (includes cholangiocarcinoma and ampullary cancer)
- •Diagnosis of resectable liver cancer
- •ECOG (Eastern Cooperative Oncology Group scale) performance status ≤ 2
排除标准
- •Serious active infection
- •Uncontrolled severe pain
- •Severe neurologic or cardiac impairment according ACSM criteria
- •Uncontrolled severe respiratory insufficiency as determined by the treating clinician
- •Any other contraindications for exercise as determined by the treating physician
- •Poor Swedish comprehension
- •Pregnancy
结局指标
主要结局
Skeletal muscle thickness
时间窗: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Skeletal muscle thickness (mm) measured through ultrasound
Skeletal muscle cross sectional area
时间窗: Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).
Skeletal muscle cross sectional area (um2) measured through ultrasound
次要结局
- Prognostic markers(Change from baseline (T0) to: 10-13 weeks (T3))
- Handgrip strength(Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).)
- Lower limb muscle strength(Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).)
- Hospitalization(5-6 months (T4))
- Physical activity(Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4).)
- Skeletal muscle protein levels(Change from baseline (T0) to: 10-13 weeks (T3).)
- Physical performance(Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).)
- Body lean mass(Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).)
- Body fat mass(Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3).)
- Nutritional status(Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4).)
- Participants' experience of the exercise program(3 months)
- Treatment related complications(4-7 weeks (T2))
- Skeletal muscle morphology(Change from baseline (T0) to: 10-13 weeks (T3).)
- Skeletal muscle metabolism(Change from baseline (T0) to: 10-13 weeks (T3).)
- Health-related quality of life(Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4).)
- Cancer-related fatigue(Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4).)
- Inflammatory markers(Change from baseline (T0) to: 10-13 weeks (T3))
研究者
Sara Mijwel
Principal Investigator
Karolinska Institutet