Effect of Integrated Care Involving Peripheral Functional Magnetic Stimulation for Sarcopenia

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06182020
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-23
• Study Start: 2023-12
• Study First Submitted QC: 2023-12-13
• Last Update Submitted: 2023-12-13
• Study First Posted: 2023-12-26
• Last Update Posted: 2023-12-26
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Education	Participants in this group will receive an educational DVD and one session of oral instructions on general care and exercise suggestions for sarcopenia.
Integrated care	Peripheral functional magnetic stimulation (ISKRA MEDICAL TESLA Former prestige Magneto therapy)	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.
Integrated care	Nutritional supplementation (ENSURE HIGH CALCIUM)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital Bei-Hu Branch; 🇨🇳 Taipei, Taiwan