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This clinical trial is a multicenter, single-blind, prospective, randomized controlled clinical application study. Subjects who met the trial criteria and signed the informed consent form were randomly divided into a control group, an experimental group 1, and an experimental group 2. After enrollment, the control group underwent a comprehensive assessment of their underlying conditions by professional physicians and received routine interventions, including basic nutritional intervention program guidance, progressive resistance exercise intervention program guidance, safety precautions, and symptomatic treatment for different complications, for a total intervention period of 24 weeks. The experimental group 1, in addition to the interventions provided to the control group, received whey protein powder supplementation for 12 weeks. The experimental group 2, on the other hand, received both whey protein powder and eldecalcitol supplementation on top of the interventions given to the control group, also for 12 weeks. The entire intervention period lasted for 24 weeks. Through regular general assessments, blood tests, measurements of muscle mass, muscle strength, and physical function, as well as analyses of negative adverse events, statistical methods were employed to evaluate the safety and efficacy of the comprehensive intervention methods for sarcopenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | After enrollment, professional doctors will conduct a comprehensive assessment of their basic conditions and provide routine interventions, mainly including basic nutrition intervention program guidance, progressive resistance exercise intervention program guidance, safety protection advice, and symptomatic treatment for different complications, with a total intervention period of 24 weeks. |
|
| experimental group 1 | Other | On the basis of the control group, whey protein powder was given to supplement for 12 weeks.60 grams of protein per day is taken in three divided doses for 12 consecutive weeks. Attention should be paid to monitoring liver and kidney function, and the dosage of protein powder should be adjusted according to the condition of the patient. |
|
| experimental group 2 | Other | On the basis of the control group, whey protein powder and eldecalcitol were given for supplementation for 12 weeks. (Supplementing whey protein powder: The protein intake is 60 grams per day, taken in three divided doses for 12 consecutive weeks. Attention should be paid to monitoring liver and kidney function, and the dosage of protein powder should be adjusted according to the condition of the patient. Supplementing eldecalcitol: eldecalcitol soft gel capsules are taken at an oral dose of 0.75μg once a day for 12 consecutive weeks.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise | Behavioral | progressive resistance exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| muscle mass | The DXA equipment is used to detect the muscle mass. | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Grip strength | Using a spring dynamometer, stand upright with the elbow joint fully extended, and use the muscle strength of the dominant hand to record the maximum reading (in kg) from three trials. | up to 24 weeks |
| 6-meter walking speed |
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Inclusion Criteria:
Age 30 or above;
Exclusion Criteria:
Resting systolic blood pressure > 200 mmHg or resting diastolic blood pressure > 100 mmHg;
Severe heart disease: moderate to severe aortic valve stenosis, acute pericarditis, acute myocarditis, myocardial infarction, uncontrollable arrhythmia;
Acute stroke within the past 2 years;
Severe airway obstruction;
Lower limb fractures in the past 1 year or upper limb fractures in the past 6 months;
Hypercalcemia (corrected albumin serum calcium > 2.60 mmol/L);
Active malignant tumors; ⑧ Chronic kidney disease stages 5;
Mental illness or severe cognitive impairment;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianfeng Tu, Doctor | Contact | +86 15925669920 | tutu5800@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianfang Ni, bachelor | Zhejiang Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First People's Hospital of Chun'an County | Recruiting | Hangzhou | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32033882 | Background | Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4. | |
| 31171417 |
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The raw data will be uploaded to the ResMan platform for raw data sharing, whose website is: http://www.medresman.org.cn/.
After the completion of the study,for 3 years
username and password
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| C547512 | eldecalcitol |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| whey protein powder | Dietary Supplement | The protein intake is 60 grams per day, taken in three divided doses for 12 consecutive weeks. Attention should be paid to monitoring liver and kidney function, and the dosage of protein powder should be adjusted according to the condition of the patient. |
|
| Eldecalcitol | Drug | Eldecalcitol soft gel capsules are taken at an oral dose of 0.75μg once a day for 12 consecutive weeks. |
|
Record the time required to walk 6 meters from the starting point at a normal speed without decelerating, and use the average result of 3 trials as the recorded walking speed (in m/s).
| up to 24 weeks |
| incidence of adverse reactions | The number of patients with adverse events within a unit time / the total number of patients in the experimental or control group during the same period * 100%. | up to 24 weeks |
| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | China |
|
| Huzhou Nanxun District People's Hospital | Recruiting | Huzhou | Zhejiang | China |
|
| Xianju People's Hospital | Recruiting | Taizhou | Zhejiang | China |
|
| Dinghai Central Hospital of Zhoushan City | Recruiting | Zhoushan | Zhejiang | China |
|
| Background |
| Cruz-Jentoft AJ, Sayer AA. Sarcopenia. Lancet. 2019 Jun 29;393(10191):2636-2646. doi: 10.1016/S0140-6736(19)31138-9. Epub 2019 Jun 3. |
| 33349543 | Background | Maeda K, Imatani J, Moritani S, Kondo H. Effects of eldecalcitol alone or a bone resorption inhibitor with eldecalcitol on bone mineral density, muscle mass, and exercise capacity for postmenopausal women with distal radius fractures. J Orthop Sci. 2022 Jan;27(1):139-145. doi: 10.1016/j.jos.2020.11.009. Epub 2020 Dec 19. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |