Clinical Intervention of Idecalcitol Combined With Whey Protein Powder and Exercise for Sarcopenia
- Conditions
- Interventions
- Registration Number
- NCT06537115
- Lead Sponsor
- Zhejiang Provincial People's Hospital
- Brief Summary
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 o...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
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Age 30 or above;
- Meeting the diagnostic criteria for sarcopenia according to the definition of AWGS; ③ Able to walk, willing to accept a comprehensive intervention plan, and guarantee to complete the treatment course; ④ Both patients and their families agree to participate in this study and sign the informed consent form.
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Resting systolic blood pressure > 200 mmHg or resting diastolic blood pressure > 100 mmHg;
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Severe heart disease: moderate to severe aortic valve stenosis, acute pericarditis, acute myocarditis, myocardial infarction, uncontrollable arrhythmia;
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Acute stroke within the past 2 years;
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Severe airway obstruction;
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Lower limb fractures in the past 1 year or upper limb fractures in the past 6 months;
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Hypercalcemia (corrected albumin serum calcium > 2.60 mmol/L);
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Active malignant tumors; ⑧ Chronic kidney disease stages 5;
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Mental illness or severe cognitive impairment;
- Long-term immobilization; ⑪ Other diseases that may interfere with the evaluation of muscle mass, muscle strength, and physical function; ⑫ Unable to cooperate with treatment due to other reasons; ⑬ Life expectancy less than 6 months.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group exercise 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 exercise 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 1 whey protein powder 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 exercise 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.) experimental group 2 whey protein powder 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.) experimental group 2 Eldecalcitol 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.)
- Primary Outcome Measures
Name Time Method muscle mass up to 24 weeks The DXA equipment is used to detect the muscle mass.
- Secondary Outcome Measures
Name Time Method Grip strength up to 24 weeks 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.
6-meter walking speed up to 24 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).
incidence of adverse reactions up to 24 weeks 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%.
Trial Locations
- Locations (5)
The First People's Hospital of Chun'an County
🇨🇳Hangzhou, Zhejiang, China
Dinghai Central Hospital of Zhoushan City
🇨🇳Zhoushan, Zhejiang, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Xianju People's Hospital
🇨🇳Taizhou, Zhejiang, China
Huzhou Nanxun District People's Hospital
🇨🇳Huzhou, Zhejiang, China