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

September 16, 2026 updated by: Xuanwu Hospital, Beijing

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: intervention group
Device: Standard treatment with pulsed magnetic therapy apparatus

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
Device: Fake stimulation therapy with pulse magnetic therapy device

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LYS [2026] No. 217-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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