Effect of Integrated Care Involving Peripheral Functional Magnetic Stimulation for Sarcopenia

NCT ID: NCT06182020

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Sarcopenia

Keywords

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Sarcopenia Functional magnetic stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Nutritional supplementation (ENSURE HIGH CALCIUM)

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type ACTIVE_COMPARATOR

Education

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type DEVICE

Nutritional supplementation (ENSURE HIGH CALCIUM)

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

Intervention Type DIETARY_SUPPLEMENT

Education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.)
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shao-Yu Chi

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital Bei-Hu Branch

Locations

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National Taiwan University Hospital Bei-Hu Branch

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Shao-Yu Chi

Role: CONTACT

Phone: +886972653975

Email: [email protected]

Other Identifiers

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202309121RIND

Identifier Type: -

Identifier Source: org_study_id