SarcopeniaNCT06347965
Construction and Effect Evaluation of the Low Load Blood Flow Restriction Training Program for Lung Cancer Patients Complicated With Sarcopenia During Chemotherapy
A study testing Low load blood flow restriction training and Progressive resistance training group in people with Sarcopenia and Lung Neoplasms, run by Xin Wang at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Lung Neoplasms
- What is being tested?
- Low load blood flow restriction training and Progressive resistance training group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 20 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310020
About this study
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:
Read more
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：
- Routine care group (Control group, CON): The researchers will provide participants with regular exercise and dietary guidance.
- 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.
- Progressive resistance training group (PRE): The researchers will provide participants with progressive resistance training.
- Conditions
- Sarcopenia, Lung Neoplasms
- Being tested
- Low load blood flow restriction training, Progressive resistance training group
- Keywords
- lung cancer, sarcopenia, the low-load blood flow restriction training, progressive resistance training
- Medical subject headings
- Sarcopenia, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low load blood flow restriction trainingBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Progressive resistance training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength
The grip strength of the participant's preferred hand
Measured: 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
Measured: ASMI will be measured at 3, 6, 9, and 12 weeks after intervention
Step speed
Measure the walking speed of 6m
Measured: Step speed will be measured at 3, 6, 9, and 12 weeks after intervention
Secondary outcomes (4)
Body mass index (BMI)
Measure height and weight using height measuring instruments and scales
Measured: BMI will be measured at 3, 6, 9, and 12 weeks after intervention
Quality of life for lung cancer patients
Using the QLQ-LC 43 scale to measure the quality of life in lung cancer patients
Measured: Quality of life for lung cancer patients will be measured at 3, 6, 9, and 12 weeks after intervention
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)
Measured: Exercise compliance will be measured at12 weeks after intervention
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
Measured: Exercise safety will be measured at12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Feb 2023
- Primary completion30 Nov 2023
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xin Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xin Wang, Zhejiang University
- Investigators
- Xin Wang, Principal investigator, graduate student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347965
- Sponsor's protocol ID
- IIT20220541B-R1
- Status last verified
- Mar 2024
- First submitted
- 28 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Effect Evaluation of the Low Load Blood Flow Restriction Training Program for Lung Cancer Patients Complicated With Sarcopenia During Chemotherapy
- ClinicalTrials.gov ID
- NCT06347965
- Acronym / sponsor ID
- IIT20220541B-R1
- Conditions
- Sarcopenia, Lung Neoplasms
- Keywords
- lung cancer, sarcopenia, the low-load blood flow restriction training, progressive resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Xin WangUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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：
- Routine care group (Control group, CON): The researchers will provide participants with regular exercise and dietary guidance.
- 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.
- Progressive resistance training group (PRE): The researchers will provide participants with progressive resistance training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Low load blood flow restriction trainingOn 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. |
| Progressive resistance training group (PRE) | Active comparator | Behavioral: Progressive resistance training groupOn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low load blood flow restriction trainingLow 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. | Behavioural | Low load blood flow restriction training group (LL-BFRT) |
| Progressive resistance training groupThe 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. | Behavioural | Progressive resistance training group (PRE) |
Primary outcome
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
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
Step speed
Time frame: Step speed will be measured at 3, 6, 9, and 12 weeks after intervention
Measure the walking speed of 6m
4 secondary outcomes
Body mass index (BMI)
Time frame: BMI will be measured at 3, 6, 9, and 12 weeks after intervention
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
Exercise compliance
Time frame: Exercise compliance will be measured at12 weeks after intervention
Exercise safety
Time frame: Exercise safety will be measured at12 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin Wang principal investigator
graduate student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low load blood flow restriction training and Progressive resistance training group in people with Sarcopenia and Lung Neoplasms, run by Xin Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip strength (time frame: Grip strength will be measured at 3, 6, 9, and 12 weeks after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.