Sarcopenia
Conditions
Keywords
Sarcopenia, intervention, idecalcitol, whey protein powder, exercise
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 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.
Interventions
BEHAVIORALexercise
progressive resistance exercise
DIETARY_SUPPLEMENTwhey 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.
DRUGEldecalcitol
Eldecalcitol soft gel capsules are taken at an oral dose of 0.75μg once a day for 12 consecutive weeks.
Sponsors
Zhejiang Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
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; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| muscle mass | up to 24 weeks | The DXA equipment is used to detect the muscle mass. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
Countries
China
Contacts
Primary ContactJianfeng Tu, Doctor
Outcome results
None listed