Clinical trial NCT06182020: Effect of Integrated Care Involving Peripheral Functional Magnetic Stimulation for Sarcopenia
Official title: The Effect of Integrated Care Involving Peripheral Functional Magnetic Stimulation and Nutritional Supplement for Age-related Sarcopenia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sarcopenia
Keywords: Sarcopenia
Functional magnetic stimulation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: Body composition
timeFrame: Before the intervention, and 1-2 weeks after the 8-week intervention
measure: Handgrip strength
timeFrame: Before the intervention, and 1-2 weeks after the 8-week intervention
measure: 5-time chair stand test
timeFrame: Before the intervention, and 1-2 weeks after the 8-week intervention
measure: 6-meter walk
timeFrame: Before the intervention, and 1-2 weeks after the 8-week intervention
Secondary outcomes:
measure: Leg circumference
timeFrame: Before the intervention, and 1-2 weeks after the 8-week intervention
measure: Cytokines related to sarcopenia
timeFrame: Before the intervention, and 1-2 weeks after the 8-week intervention
measure: Nutritional status
timeFrame: Before the intervention, and 1-2 weeks after the 8-week intervention
measure: Activity level
timeFrame: Before the intervention, and 1-2 weeks after the 8-week intervention
measure: Life quality
timeFrame: Before the intervention, and 1-2 weeks after the 8-week intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital Bei-Hu Branch
Study officials:
affiliation: National Taiwan University Hospital Bei-Hu Branch
name: Shao-Yu Chi
role: PRINCIPAL_INVESTIGATOR
References: