Construction and Effect Evaluation of the Low Load Blood Flow Restriction Training Program for Lung Cancer Patients Complicated With Sarcopenia During Chemotherapy
- Conditions
- SarcopeniaLung Neoplasms
- Interventions
- Behavioral: Progressive resistance training groupBehavioral: Low load blood flow restriction training
- Registration Number
- NCT06347965
- Lead Sponsor
- Xin Wang
- Brief Summary
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：
1. Routine care group (Control group, CON): The researchers will provide participants with regular exercise and dietary guidance.
2. 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.
3. Progressive resistance training group (PRE): The researchers will provide participants with progressive resistance training.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Progressive resistance training group (PRE) Progressive resistance training group On the basis of routine care, progressive resistance training will be conducted on subjects who meet the inclusion and exclusion criteria, guided by the progressive resistance training program for malignant tumor patients in the "ACSM Exercise Testing and Exercise Prescription Guidelines: 10th Edition" published by the People's Health Press. Low load blood flow restriction training group (LL-BFRT) Low load blood flow restriction training On the basis of routine care, participants who meet the inclusion and exclusion criteria will be guided to undergo low-load blood flow restriction training. Based on the constructed "Low load Blood Flow Restriction Training Program for Chemotherapy Stage Lung Cancer Patients with Sarcopenia", participants will be guided to undergo low-load blood flow restriction training.
- Primary Outcome Measures
Name Time Method Grip strength 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) 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 Step speed will be measured at 3, 6, 9, and 12 weeks after intervention Measure the walking speed of 6m
- Secondary Outcome Measures
Name Time Method Exercise safety Exercise safety will be measured at12 weeks after intervention Record the frequency and time of adverse events caused by exercise, such as muscle pain, joint pain, dizziness, skin bruising, etc., and calculate the incidence rate of adverse events
Exercise compliance Exercise compliance will be measured at12 weeks after intervention This includes participation rate, interruption rate (number of missed training sessions), termination rate (termination of training before 12 weeks), and dose adjustment rate (adjustment of training load or frequency)
Body mass index (BMI) BMI will be measured at 3, 6, 9, and 12 weeks after intervention Measure height and weight using height measuring instruments and scales
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 Using the QLQ-LC 43 scale to measure the quality of life in lung cancer patients
Trial Locations
- Locations (1)
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳HangZhou, Zhejiang, China