Clinical trial NCT06347965: Construction and Effect Evaluation of the Low Load Blood Flow Restriction Training Program for Lung Cancer Patients Complicated With Sarcopenia During Chemotherapy
Official title: Construction and Effect Evaluation of the Low Load Blood Flow Restriction Training Program for Lung Cancer Patients Complicated With Sarcopenia During Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lung Neoplasms
Keywords: lung cancer
sarcopenia
the low-load blood flow restriction training
progressive resistance training
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Grip strength
timeFrame: Grip strength will be measured at 3, 6, 9, and 12 weeks after intervention
measure: Appendicular Skeletal Muscle Index (ASMI)
timeFrame: ASMI will be measured at 3, 6, 9, and 12 weeks after intervention
measure: Step speed
timeFrame: Step speed will be measured at 3, 6, 9, and 12 weeks after intervention
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: BMI will be measured at 3, 6, 9, and 12 weeks after intervention
measure: Quality of life for lung cancer patients
timeFrame: Quality of life for lung cancer patients will be measured at 3, 6, 9, and 12 weeks after intervention
measure: Exercise compliance
timeFrame: Exercise compliance will be measured at12 weeks after intervention
measure: Exercise safety
timeFrame: Exercise safety will be measured at12 weeks after intervention
Other outcomes:
Locations:
city: HangZhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: graduate student
name: Xin Wang
role: PRINCIPAL_INVESTIGATOR
References: