Effect of Integrated Care Involving Peripheral Functional Magnetic Stimulation for Sarcopenia

Study Overview
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Brief Summary
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The goal of this clinical randomized trial is to test whether an integrated care involving peripheral functional magnetic stimulation and nutritional supplement is beneficial in population with age-related sarcopenia, as compared to usual care.

Detailed Description
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We will recruit participants with sarcopenia or possible sarcopenia. The participants will be divided into 2 groups. One group, the integrated care group, will receive both the peripheral functional magnetic stimulation to both the upper and lower limbs and nutritional supplement for consecutive 8 weeks. The other group, the usual care group, will receive an educational digital versatile disc (DVD) and a handbook for exercise suggestions on sarcopenia. We will compare before and after the intervention about the body composition, handgrip strength, 5-time chair stand test, 6-meter walk, and blood test for C-reactive protein and other cytokines related to sarcopenia. The participant's nutritional condition, activity level, life quality will also be analyzed via questionnaires before and after the intervention.

Official Title
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The Effect of Integrated Care Involving Peripheral Functional Magnetic Stimulation and Nutritional Supplement for Age-related Sarcopenia

Conditions
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Sarcopenia

Intervention / Treatment
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* Device: Peripheral functional magnetic stimulation (ISKRA MEDICAL TESLA Former prestige Magneto therapy)
* Dietary Supplement: Nutritional supplementation (ENSURE HIGH CALCIUM)
* Behavioral: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 65 to 90 Can walk independently for over 15 minutes Diagnosed with possible sarcopenia or sarcopenia (by Asian Working Group for Sarcopenia: 2019 Consensus Update onSarcopenia Diagnosis and Treatment) Exclusion Criteria: Cognitive impairment History of cerebrovascular disease Deep vein thrombosis Malignancy under treatment Coagulopathy Serious orthopedic condition over limbs Inability to walk independently without assistive device Any other conditions not suggested to performance exercise Medical implants (e.g. pacemaker, defibrillator, deep brain nerve stimulation, infusion pump, etc.)

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated care<br>Participants in this group will receive both the peripheral functional magnetic stimulation to both the upper and lower limbs and nutritional supplement for consecutive 8 weeks. | Device: Peripheral functional magnetic stimulation (ISKRA MEDICAL TESLA Former prestige Magneto therapy)<br>* The peripheral functional magnetic stimulation will be conducted 30 minutes a session, 2 sessions per week, for consecutive 8 weeks. The stimulation will be placed over bilateral forearm flexor muscles and bilateral thighs over rectus femoris muscles.<br>Dietary Supplement: Nutritional supplementation (ENSURE HIGH CALCIUM)<br>* The nutritional supplementation includes 7 cans of ENSURE HIGH CALCIUM per week for 8 consecutive weeks.<br>|
| Active Comparator: Usual care<br>Participants in this group will receive an educational DVD and one session of oral instructions on general care and exercise suggestions for sarcopenia. | Behavioral: Education<br>* The education includes a DVD and one session of oral instructions on general care and exercise suggestions for sarcopenia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | We use dual energy x-ray absorptiometry to evaluate the muscle mass (kg/m2) in the subjects. | Before the intervention, and 1-2 weeks after the 8-week intervention | 
| Handgrip strength | We use a dynamometer to measure the handgrip strength (kg) | Before the intervention, and 1-2 weeks after the 8-week intervention | 
| 5-time chair stand test | We measure the time of a subject to transfer from a seated to a standing position and back to sitting five times. | Before the intervention, and 1-2 weeks after the 8-week intervention | 
| 6-meter walk | We measure the time of a subject to walk with the usual speed straightly for 6 meters. | Before the intervention, and 1-2 weeks after the 8-week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg circumference | We measure the largest calf circumference with seated position with knee flexed in 90 degrees. | Before the intervention, and 1-2 weeks after the 8-week intervention | 
| Cytokines related to sarcopenia | We will check the concentrations of cytokines including the c-reactive protein from our subjects. | Before the intervention, and 1-2 weeks after the 8-week intervention | 
| Nutritional status | We use the questionnaire Mini Nutritional Assessment to evaluate the subjects' nutritional status. | Before the intervention, and 1-2 weeks after the 8-week intervention | 
| Activity level | We use the International Physical Activity Questionnaire to evaluate the subjects' activity levels. | Before the intervention, and 1-2 weeks after the 8-week intervention | 
| Life quality | We use the EuroQol-5 dimensions (EQ-5D) and Taiwan Short Form-36 questionnaires to evaluate the subjects' health life quality. | Before the intervention, and 1-2 weeks after the 8-week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcopenia, Functional magnetic stimulation