Construction and Effect Evaluation of the Low Load Blood Flow Restriction Training Program for Lung Cancer Patients Complicated With Sarcopenia During Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Grip strength
研究概览
简要总结
The goal of this clinical trial is to verify the effectiveness and safety of the low load blood flow restriction training program. The intervention effect, tolerance and compliance of low load blood flow restriction training and progressive resistance training on lung cancer patients complicated with sarcopenia during chemotherapy will be compared, in order to provide new ideas for improving or reversing sarcopenia.
The main questions it aims to answer are:
Can low load blood flow restriction training improve sarcopenia in chemotherapy induced lung cancer patients? Which training method is more effective and tolerable between low load blood flow restriction training and progressive resistance training?
Participants will be randomly divided into 3 groups：
- Routine care group (Control group, CON): The researchers will provide participants with regular exercise and dietary guidance.
- Low load blood flow restriction group (LL-BFRT): The researchers will provide participants with a low load blood flow restriction training program constructed by our research group.
- Progressive resistance training group (PRE): The researchers will provide participants with progressive resistance training.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The pathological diagnosis is lung cancer, and the diagnostic criteria refer to the 2023 edition of the Clinical Diagnosis and Treatment Guidelines for Lung Cancer of the Chinese Medical Association.
- •Diagnosed as sarcopenia, the diagnostic criteria refer to the 2023 version of the Expert Consensus on the Diagnosis and Treatment of sarcopenia in the Elderly in China.
- •Chemotherapy has been carried out and the remaining chemotherapy frequency is ≥ 4 times.
- •Physical disability free, Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2 points
- •No language communication barriers, able to cooperate in completing scale assessments
- •Expected life>6 months
- •Previous irregular exercise habits
- •Patients and their families have informed consent and voluntarily join
- •A person who has a smartphone and can complete WeChat check-in
排除标准
- •Merge with other malignant tumors
- •There are contraindications or symptoms or diseases that affect exercise, such as uncontrolled hypertension, venous thrombosis, infection, platelet count<50 × 109/L, white blood cell count<3.0 × 109/L, hemoglobin<10 mg/dL, bleeding tendency, arrhythmia, heart failure, unstable angina, heart valve disease, chronic obstructive pulmonary disease, asthma, limb dysfunction, severe muscle, bone and joint diseases, etc
- •The risk factor score table for blood flow restriction training scores>2
- •During rest, blood oxygen saturation ≤ 90%
- •Cannot conduct human body composition analyzer testing, such as for patients with cardiovascular stent implantation, pacemaker equipped, artificial joint replacement, or amputation
- •Patients carrying PICC
- •Patients with cognitive impairment and mental illness
- •Patients with planned weight loss
结局指标
主要结局
Grip strength
时间窗: Grip strength will be measured at 3, 6, 9, and 12 weeks after intervention
The grip strength of the participant's preferred hand
Appendicular Skeletal Muscle Index (ASMI)
时间窗: ASMI will be measured at 3, 6, 9, and 12 weeks after intervention
Using a human body composition analyzer (ICOMEON-FI2001B) to measure the skeletal muscle mass (ASM) of the limbs, and calculating ASMI using a formula. ASMI=ASM/height\^2
Step speed
时间窗: Step speed will be measured at 3, 6, 9, and 12 weeks after intervention
Measure the walking speed of 6m
次要结局
- Exercise safety(Exercise safety will be measured at12 weeks after intervention)
- Exercise compliance(Exercise compliance will be measured at12 weeks after intervention)
- Body mass index (BMI)(BMI will be measured at 3, 6, 9, and 12 weeks after intervention)
- Quality of life for lung cancer patients(Quality of life for lung cancer patients will be measured at 3, 6, 9, and 12 weeks after intervention)
研究者
Xin Wang
Graduate student
Zhejiang University