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

NCT ID: NCT06347965

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-02-20

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.

Conditions

Sarcopenia; Lung Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Routine care group (Control group, CON)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

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.

Group Type: EXPERIMENTAL

Low load blood flow restriction training

Intervention Type: BEHAVIORAL

Low load blood flow restriction training will be conducted on the subjects three times a week. Each training session includes upper and lower limb training, with 4 groups trained and repeated 30, 15, 15, and 15 times for each group. Train for a total of 12 weeks.The resistance strength will remain at 30% RM for weeks 1-12.

Progressive resistance training group (PRE)

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.

Group Type: ACTIVE_COMPARATOR

Progressive resistance training group

Intervention Type: BEHAVIORAL

The subjects will undergo progressive resistance training three days a week, three groups per day, with each group repeating 10 times. Training includes upper and lower limbs. The resistance load increases over time, with a resistance load of 30% RM for weeks 1-4, 50% RM for weeks 5-8, and 70% RM for weeks 9-12.

Interventions

Low load blood flow restriction training

Low load blood flow restriction training will be conducted on the subjects three times a week. Each training session includes upper and lower limb training, with 4 groups trained and repeated 30, 15, 15, and 15 times for each group. Train for a total of 12 weeks.The resistance strength will remain at 30% RM for weeks 1-12.

Intervention Type: BEHAVIORAL

Progressive resistance training group

The subjects will undergo progressive resistance training three days a week, three groups per day, with each group repeating 10 times. Training includes upper and lower limbs. The resistance load increases over time, with a resistance load of 30% RM for weeks 1-4, 50% RM for weeks 5-8, and 70% RM for weeks 9-12.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xin Wang

OTHER

Sponsor Role: lead

Responsible Party

Xin Wang

Graduate student

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xin Wang

Role: PRINCIPAL_INVESTIGATOR

graduate student

Locations

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

IIT20220541B-R1

Identifier Type: -

Identifier Source: org_study_id