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NCT Number: NCT06347965

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310020, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Grip strength

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

    The grip strength of the participant's preferred hand

  2. Appendicular Skeletal Muscle Index (ASMI)

    Time frame: 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

  3. Step speed

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

    Measure the walking speed of 6m

Secondary outcomes

  1. Body mass index (BMI)

    Time frame: BMI will be measured at 3, 6, 9, and 12 weeks after intervention

    Measure height and weight using height measuring instruments and scales

  2. Quality of life for lung cancer patients

    Time frame: 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

  3. Exercise compliance

    Time frame: 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)

  4. Exercise safety

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Xin Wang

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 4, 2024
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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