A Clinical Study on the Improvement of Frailty and Sarcopenia in Elderly Community Residents Through Pulsed Electromagnetic Field Therapy
A Multi-center, Randomized, Double-blind, Sham Stimulation-controlled Clinical Study on the Improvement of Frailty and Sarcopenia in Elderly Community Residents Through Pulsed Electromagnetic Field Therapy
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria (1) Voluntarily sign the informed consent form; (2) Aged 60 to 80 years, male or female, residing in the community and having stable living conditions for the past 6 months; (3) Meet the AWGS 2025 diagnostic criteria for sarcopenia in Asia or have a Fried frailty phenotype score of ≥3; (4) Baseline TUG test time >10 seconds; (5) Have basic walking ability, able to complete a 10-meter walk independently or with the assistance of an aid; (6) Able to understand and comply with the study procedures.
Exclusion Criteria (1) Subjects with implanted electromagnetic-sensitive active devices, such as cardiac pacemakers, implantable defibrillators, vascular stents, vena cava filters, nerve stimulators, insulin pumps, etc.; (2) Subjects with edema in the lower extremities caused by various reasons; (3) Subjects with skin lesions, infections, ulcers at the intervention site, or conditions such as lower extremity trauma, unhealed fractures, severe joint lesions, diabetic foot, limb defects, etc., which prevent safe walking or intervention; (4) Subjects with metal implants such as metal prostheses, steel plates, bone screws, etc. in the lower extremity region, which may affect the safety of intervention; (5) Subjects with severe mental illness, cognitive impairment, dementia, or abnormal consciousness, who are unable to cooperate with the study; (6) Subjects with severe heart, lung, liver, kidney, or other organ failure or advanced malignant tumors, with limited expected survival, who are unable to complete the study process; (7) Subjects who have participated in other clinical trials within the past 3 months; （8）or who, in the comprehensive judgment of the researcher, have other conditions that make them unsuitable to participate in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention group
|
Using a pulse magnetic therapy device (model: KN-MME), the standard treatment mode was implemented: magnetic field strength of 1mT, frequency of 3.3kHz, pulse repetition rate of 50Hz; the treatment area was both lower limbs, with 10 minutes of treatment on each side, and a total of 20 minutes per session; the treatment frequency was twice a week, with a total of 24 treatments completed. |
|
Sham Comparator: control group
|
Using the same model of pulse magnetic therapy device (model: KN-MME) as the intervention group, a blank treatment mode was implemented: only simulating the intervention procedure (with appearance, operating sound, and vibration completely consistent with the intervention group), with no magnetic field output from the coil, ensuring the blinding effect for the subjects; the treatment site, duration, frequency, and total number of treatments were all completely consistent with the intervention group. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The change value of the Timed Up and Go (TUG) test after 24 treatments compared to the baseline
Time Frame: The treatment area is the bilateral lower limbs, with 10 minutes of treatment for each limb, and a total single treatment duration of 20 minutes; the treatment frequency is twice a week, with a total of 24 treatments completed.
|
The treatment area is the bilateral lower limbs, with 10 minutes of treatment for each limb, and a total single treatment duration of 20 minutes; the treatment frequency is twice a week, with a total of 24 treatments completed.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LYS [2026] No. 217-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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