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

NCT06347965 | Completed

• 1 other identifier: IIT20220541B-R1
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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. 1.Routine care group (Control group, CON): The researchers will provide participants with regular exercise and dietary guidance.
2. 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. 3.Progressive resistance training group (PRE): The researchers will provide participants with progressive resistance training.

Conditions

Sarcopenia; Lung Neoplasms

Keywords

lung cancer; sarcopenia; the low-load blood flow restriction training; progressive resistance training

Outcome Measures

Primary Outcomes (3)

• Grip strength

  The grip strength of the participant's preferred hand

  Grip strength will be measured at 3, 6, 9, and 12 weeks after intervention

• Appendicular Skeletal Muscle Index (ASMI)

  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

  ASMI will be measured at 3, 6, 9, and 12 weeks after intervention

• Step speed

  Measure the walking speed of 6m

  Step speed will be measured at 3, 6, 9, and 12 weeks after intervention

Secondary Outcomes (4)

• 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

• Exercise compliance

  Exercise compliance will be measured at12 weeks after intervention

• Exercise safety

  Exercise safety will be measured at12 weeks after intervention

Study Arms (3)

Routine care group (Control group, CON)

NO INTERVENTION

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

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

EXPERIMENTAL

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.

Behavioral: Low load blood flow restriction training

Progressive resistance training group (PRE)

ACTIVE COMPARATOR

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.

Behavioral: Progressive resistance training group

Interventions

Low load blood flow restriction training 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.

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

Progressive resistance training group 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.

Progressive resistance training group (PRE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xin Wang: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310020, China

Location

MeSH Terms

Conditions

Sarcopenia; Lung Neoplasms

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xin Wang

  graduate student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Graduate student

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 4, 2024
• Study Start: February 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: February 20, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)