Effect of Integrated Care Involving Peripheral Functional Magnetic Stimulation for Sarcopenia

National Taiwan University

Status: Not yet enrolling

Conditions: Sarcopenia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06182020

202309121RIND

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Integrated care

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Nutritional supplementation (ENSURE HIGH CALCIUM)

Device: Peripheral functional magnetic stimulation (ISKRA MEDICAL TESLA Former prestige Magneto therapy)

Usual care

Active Comparator group

Description:

Participants in this group will receive an educational DVD and one session of oral instructions on general care and exercise suggestions for sarcopenia.

Treatment:

Behavioral: Education