Effect of Integrated Care Involving Peripheral Functional Magnetic Stimulation for Sarcopenia

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Device: Peripheral functional magnetic stimulation (ISKRA MEDICAL TESLA Former prestige Magneto therapy); Dietary supplement: Nutritional supplementation (ENSURE HIGH CALCIUM); Behavioral: Education

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shao-Yu Chi; Phone Number: +886972653975; Email: shaoyuchi.tw@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital Bei-Hu Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrated care; 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); 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.; Dietary supplement: Nutritional supplementation (ENSURE HIGH CALCIUM); The nutritional supplementation includes 7 cans of "ENSURE HIGH CALCIUM" per week for 8 consecutive weeks.
Active Comparator: Usual care; 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; The education includes a DVD and one session of oral instructions on general care and exercise suggestions for sarcopenia.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Shao-Yu Chi, National Taiwan University Hospital Bei-Hu Branch

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Sarcopenia; Functional magnetic stimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: 202309121RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No