Sarcopenia
Conditions
Interventions
Elderly Sarcopenia Intervention Group with 0.5mg Mecobalamin:Subjects in each group received intramuscular injections of mecobalamin at a dose of 0.5mg, three times a week for six months
Elderly Sarcopenia Intervention Group with 1mg Mecobalamin:Subjects in each group received intramuscular injections of mecobalamin at a dose of 1mg, three times a week for six months
Elderly Sarcopenia Intervention Group with 2.5mg Mecobalamin:Subjects in each group received intramuscular injections of mecobalamin at a dose of 2.5mg, three times a week for six months
Elderly Sarcopenia Control Group:Subjects in each group received intramuscular injections of an equivalent amount of saline solution, three times a week for six months
Sarcopenia Combined with Lumbar Disc Herniation Intervention Group with 0.5mg Mecobalamin:Subjects in each group received intramuscular injections of mecobalamin at a dose of 0.5mg, three times a week
Sarcopenia Combined with Lumbar Disc Herniation Intervention Group with 1mg Mecobalamin:Subjects in each group received intramuscular injections of mecobalamin at a dose of 1mg, three times a week for
Sarcopenia Combined with Lumbar Disc Herniation Intervention Group with 2.5mg Mecobalamin:Subjects in each group received intramuscular injections of mecobalamin at a dose of 2.5mg, three times a week
Sarcopenia Combined with Lumbar Disc Herniation Control Group:Subjects in each group received intramuscular injections of an equivalent amount of saline solution, three times a week for six months
Sponsors
The Second Affiliated Hospital of University of South China
Eligibility
Sex/Gender
Male
Age
30 Years to 90 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria for the Elderly Sarcopenia Group: 1. Age>=60 years old male, with the ability to walk independently; 2. Meet the diagnostic criteria for sarcopenia (according to the 2019 edition of the Asian Consensus on the Diagnosis and Treatment of Sarcopenia): decreased muscle strength (grip strength: male<28kg), decreased skeletal muscle mass of the limbs (male< 7.0 kg/m², dual-energy X-ray absorptiometry) and/or decreased physical function (6 m gait<1.0m/s); 3. Stable health; 4. Agree to participate in this trial and sign the informed consent form. Inclusion Criteria for Lumbar Intervertebral Disc Herniation with Sarcopenia Group: 1. Male aged 30-50 years old; 2. Lumbar CT or MRI shows that it is consistent with the diagnosis of lumbar intervertebral disc herniation or lumbar nerve root compression, lumbar spinal stenosis, and lumbar degeneration; 3. The main symptoms of nerve roots in the lower limbs, accompanied by pain and/or numbness and muscle tension in the waist and lower limbs; 4. During the treatment period, discontinue interventions that affect the efficacy (such as wax therapy, hormone drugs, non-steroidal anti-inflammatory drugs, etc.); 5. The patient has no clear indication for surgery and chooses conservative treatment; 6. Those who voluntarily participate in this study and sign the informed consent form; 7. Meet the diagnostic criteria for sarcopenia (according to the 2019 edition of the Asian Consensus on the Diagnosis and Treatment of Sarcopenia): decreased muscle strength (grip strength: male<28kg), decreased skeletal muscle mass of limbs (male<7.0 kg/m², dual-energy X-ray absorptiometry) and/or decreased physical function (6-meter gait <1.0m/s).
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Elderly Sarcopenia Group: 1. Those who do not meet the above diagnostic criteria and inclusion criteria; 2. History of allergy to methylcobalamin or any excipients in the prescription; 3. Engage in work related to mercury and its compounds; 4. Peripheral neuropathy, anterior horn lesion of the spinal cord, radiculopathy, plexopathy, mononeuropathy, multiple peripheral neuropathy, hereditary motor sensory peripheral neuropathy, diabetic peripheral neuropathy and other nervous system diseases that can affect muscle quality and function; 5. Duchenne muscular dystrophy, polymyositis, myotonic dystrophy and other muscle lesions that can affect muscle mass and function; 6. Vitamin D deficiency, vitamin B12 deficiency and other diseases that can affect muscle mass and function; 7. Resting systolic blood pressure > 200 mmHg or resting diastolic blood pressure > 100 mmHg; 8. Severe heart disease: moderate to severe aortic stenosis, acute pericarditis, acute myocarditis, myocardial infarction, uncontrollable arrhythmia; 9. Acute stroke in the past 2 years; 10. Severe airway obstruction; 11. Lower limb fracture within the last 1 year or upper limb fracture within the last 6 months; 12. Hypercalcemia (corrected albumin serum calcium> 2.60 mmol/L); 13. Active malignant tumor; 14. Chronic kidney disease stage 4-5; 15. Combined with psychosis or moderate-to-severe cognitive impairment; 16. long-term braking; 17. Other diseases that can interfere with the assessment and testing of muscle mass, muscle strength and physical function; 18. Inability to cooperate with treatment due to other reasons. Exclusion Criteria for Lumbar Intervertebral Disc Herniation with Sarcopenia Group: 1. Those who do not meet the above diagnostic criteria and inclusion criteria; 2. Nervous system diseases that can affect muscle quality and function in addition to lumbar intervertebral disc herniation, such as peripheral neuropathy, anterior horn lesion of the spinal cord, radiculopathy, plexopathy, mononeuropathy, multiple peripheral neuropathy, hereditary motor sensory peripheral neuropathy, diabetic peripheral neuropathy, etc.; 3. Subjects with spondylolisthesis or nucleus pulposus herniation that severely compresses the cauda equina nerve, or who have obvious indications for surgery or are not suitable for conservative treatment; 4. Suffering from other diseases with low back pain symptoms, such as ankylosing spondylitis, etc.; 5. History of allergy to methylcobalamin or any excipients in the prescription; 6. Engage in work related to mercury and its compounds; 7. Duchenne muscular dystrophy, polymyositis, myotonic dystrophy and other muscle lesions that can affect muscle mass and function; 8. Vitamin D deficiency, vitamin B12 deficiency and other diseases that can affect muscle mass and function; 9. Resting systolic blood pressure > 200 mmHg or resting diastolic blood pressure > 100 mmHg; 10. Severe heart disease: moderate to severe aortic stenosis, acute pericarditis, acute myocarditis, myocardial infarction, uncontrollable arrhythmia; 11. Acute stroke in the past 2 years; 12. Severe airway obstruction; 13. Lower limb fracture within the last 1 year or upper limb fracture within the last 6 months; 14. Hypercalcemia (corrected albumin serum calcium> 2.60 mmol/L); 15. Active malignant tumor; 16. Chronic kidney disease stage 4-5; 17. Combined with mental illness or moderate-to-severe cognitive impairment; 18. long-term braking; 19. Other diseases that
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| skeletal muscle mass of limbs;Skeletal Muscle Mass Index ;grip;Walking Speed Test;Sit-to-Stand Test;Standing Balance Test; | — |
Secondary
| Measure | Time frame |
|---|---|
| Walking Test;Stair Climbing Test;400-Meter Walking Test;Timed Up and Go Test;Single-Leg Stand Test;Anthropometric Measurements ;Body Composition Measurements;Laboratory Tests ;muscle biopsy;Electromyography (EMG) Results;Muscle-Related Gene Expression;Muscle Immunohistochemistry;Questionnaires; | — |
Countries
China
Contacts
Public ContactXianghang Luo
The Second Affiliated Hospital of University of South China
Outcome results
None listed