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Clinical Trials/NCT06182020
NCT06182020
Not Yet Recruiting
N/A

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

National Taiwan University Hospital1 site in 1 country80 target enrollmentDecember 2023
ConditionsSarcopenia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
National Taiwan University Hospital
Enrollment
80
Locations
1
Primary Endpoint
Handgrip strength
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2023
End Date
March 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.)

Outcomes

Primary Outcomes

Handgrip strength

Time Frame: 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

Time Frame: 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.

Body composition

Time Frame: 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.

6-meter walk

Time Frame: 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 Outcomes

  • Leg circumference(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)
  • Cytokines related to sarcopenia(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)
  • Activity level(Before the intervention, and 1-2 weeks after the 8-week intervention)

Study Sites (1)

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