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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06347965
• Other study ID #: IIT20220541B-R1
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: February 20, 2024

Study information

• Verified date: March 2024
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: February 20, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Sarcopenia

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Zhejiang University School of Medicine	HangZhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Xin Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Step speed	Measure the walking speed of 6m	Step speed will be measured at 3, 6, 9, and 12 weeks after intervention
Secondary	Body mass index (BMI)	Measure height and weight using height measuring instruments and scales	BMI will be measured at 3, 6, 9, and 12 weeks after intervention
Secondary	Quality of life for lung cancer patients	Using the QLQ-LC 43 scale to measure the quality of life in lung cancer patients	Quality of life for lung cancer patients will be measured at 3, 6, 9, and 12 weeks after intervention
Secondary	Exercise compliance	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)	Exercise compliance will be measured at12 weeks after intervention
Secondary	Exercise safety	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 safety will be measured at12 weeks after intervention