Effect of Integrated Care Involving Peripheral Functional Magnetic Stimulation for Sarcopenia

NCT06182020 | Unknown

• 1 other identifier: 202309121RIND
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

Sarcopenia; Functional magnetic stimulation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Leg circumference

  Before the intervention, and 1-2 weeks after the 8-week intervention

• Cytokines related to sarcopenia

  Before the intervention, and 1-2 weeks after the 8-week intervention

• Nutritional status

  Before the intervention, and 1-2 weeks after the 8-week intervention

• Activity level

  Before the intervention, and 1-2 weeks after the 8-week intervention

• Life quality

  Before the intervention, and 1-2 weeks after the 8-week intervention

Study Arms (2)

Integrated care

EXPERIMENTAL

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); Dietary Supplement: Nutritional supplementation (ENSURE HIGH CALCIUM)

Usual care

ACTIVE COMPARATOR

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

Interventions

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

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.

Integrated care

Nutritional supplementation (ENSURE HIGH CALCIUM) DIETARY_SUPPLEMENT

The nutritional supplementation includes 7 cans of "ENSURE HIGH CALCIUM" per week for 8 consecutive weeks.

Integrated care

Education BEHAVIORAL

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

Usual care

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Bei-Hu Branch

Taipei, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Dietary Supplements; Educational Status

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Socioeconomic Factors; Population Characteristics

Study Officials

• Shao-Yu Chi

  National Taiwan University Hospital Bei-Hu Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shao-Yu Chi

CONTACT

+886972653975; shaoyuchi.tw@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 26, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: December 26, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)