Effect of Integrated Care Involving Peripheral Functional Magnetic Stimulation for Sarcopenia

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06182020
• Other study ID #: 202309121RIND
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: March 2025

Study information

• Verified date: November 2023
• Source: National Taiwan University Hospital
• Contact: Shao-Yu Chi
• Phone: +886972653975
• Email: shaoyuchi.tw[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Sarcopenia

Intervention

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.

Behavioral:
• Education
The education includes a DVD and one session of oral instructions on general care and exercise suggestions for sarcopenia.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Bei-Hu Branch	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Handgrip strength	We use a dynamometer to measure the handgrip strength (kg)	Before the intervention, and 1-2 weeks after the 8-week intervention
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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