A Clinical Study on the Improvement of Frailty and Sarcopenia in Elderly Community Residents Through Pulsed Electromagnetic Field Therapy

Overview

The entire clinical study will be conducted strictly following the following procedure: 1) Informed Consent If you decide to participate in this trial, we will first ensure that you fully understand the research purpose, procedure, possible benefits, and risks before conducting trial-related activities, and you will voluntarily sign the informed consent form. If a new version of the informed consent form is generated during the trial, you will also need to sign it again. 2\) Screening: After signing this informed consent form, the first step is screening. The purpose of screening is to determine whether you meet the requirements for participating in this clinical trial. We will collect your medical history, fill out general information, conduct a physical examination, measure vital signs, height, and weight, and collect blood routine, liver and kidney function tests (which should at least include the following indicators: alanine aminotransferase, aspartate aminotransferase, γ-glutamyltranspeptidase, creatine kinase, creatinine, urea, uric acid, albumin, glucose, low-density lipoprotein, total cholesterol, triglycerides, potassium, sodium, calcium). We will also complete professional assessments related to sarcopenia and frailty, including the Timed Up and Go (TUG) test, calf circumference measurement, grip strength test, Bioelectrical Impedance Analysis-Skeletal Muscle Index (BIA-SMI), 4-meter daily walking speed test, Sarcopenia Assessment Rating Scale (SARC-F), and Fried frailty phenotype assessment. After the aforementioned procedures are completed, the research doctor will determine whether you can continue participating in the clinical trial. If you are unable to continue participating in the trial, the research doctor will also explain the reasons to you. 3\) Randomization: According to the randomization rules, you will be randomly assigned (similar to flipping a coin) to either the intervention group or the control group, with a 50% probability for each group. Throughout the entire study period, neither you nor the researchers who are conducting the study will be informed of your group assignment, and the blinding will be maintained until the end of the study. 4\) After being enrolled in the study intervention, you are required to attend treatment at the designated location according to the appointment time. Regardless of which group you are assigned to, the treatment site, duration, and procedure are completely identical. If you are assigned to the intervention group, the equipment will output standard pulsed electromagnetic fields for treatment; if you are assigned to the control group, the equipment will only simulate sound, vibration, and the operation process without generating magnetic field output, which is used for comparing the study effects. During each treatment session, you only need to sit quietly and cooperate, without any additional exercise. 5\) Follow-up assessment time and content: You are required to cooperate with the researchers to complete assessments at two time points: before the first treatment (baseline) and 2-5 days after completing 24 treatments. For each assessment, you need to cooperate with the researchers to complete the Timed Up and Go (TUG) test, calf circumference measurement, BIA-SMI, grip strength test, sarcopenia screening scale (SARC-F), 4-meter usual walking speed, Fried frailty phenotype assessment, Berg Balance Scale (BBS), single-leg standing time, five sit-to-stand tests (5STS), pain score (VAS), European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L), Short Physical Performance Battery (SPPB), intrinsic capacity assessment (IC), Activities of Daily Living (ADL) scale, Mini-Nutrient Assessment (MNA), Geriatric Depression Scale-Short Form (GDS-SF), Mini-Mental State Examination (MMSE), and Montreal Cognitive Assessment (MoCA). The tests you have completed during the screening period will not be repeated during the baseline assessment. Additionally, the following laboratory tests are required for each assessment: follistatin, myostatin, IGF-1, interleukin-6 (IL-6), TNF-α, growth differentiation factor-15 (GDF-15), peripheral blood free mitochondrial DNA content, clusterin C-terminal fragment-22 (CAF-22), and metabolomics. These tests require approximately 15ml of venous blood (3-5 tubes of blood). Throughout the study, the researchers will monitor and record any adverse events and safety-related situations. 6\) Upon completion of all 24 treatments and the final assessment, you will have completed your participation in this study, and will then return to your regular health management and clinical diagnosis and treatment.