Construction and Effect Evaluation of the Low Load Blood Flow Restriction Training Program for Lung Cancer Patients Complicated With Sarcopenia During Chemotherapy

Xin Wang

Status: Completed

Conditions: Lung Neoplasms; Sarcopenia

Treatments: Behavioral: Low load blood flow restriction training; Behavioral: Progressive resistance training group

Study type: Interventional

Funder types: Other

Identifiers

NCT06347965

IIT20220541B-R1

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 3 patient groups

Routine care group (Control group, CON)

No Intervention group

Description:

During hospitalization, patients will be given routine exercise and dietary guidance.

Low load blood flow restriction training group (LL-BFRT)

Experimental group

Description:

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.

Treatment:

Behavioral: Low load blood flow restriction training

Progressive resistance training group (PRE)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Progressive resistance training group