SarcopeniaNCT06182020
Effect of Integrated Care Involving Peripheral Functional Magnetic Stimulation for Sarcopenia
A study testing Peripheral functional magnetic stimulation (ISKRA MEDICAL TESLA Former prestige Magneto therapy), Nutritional supplementation (ENSURE HIGH CALCIUM) and Education in people with Sarcopenia, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Peripheral functional magnetic stimulation (ISKRA MEDICAL TESLA Former prestige Magneto therapy), Nutritional supplementation (ENSURE HIGH CALCIUM) and Education
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2023to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- Cognitive impairment
- History of cerebrovascular disease
- Deep vein thrombosis
- Malignancy under treatment
- Coagulopathy
- Serious orthopedic condition over limbs
Show all 9Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Integrated Care Involving Peripheral Functional Magnetic Stimulation and Nutritional Supplement for Age-related Sarcopenia
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Peripheral functional magnetic stimulation (ISKRA MEDICAL TESLA Former prestige Magneto therapy), Nutritional supplementation (ENSURE HIGH CALCIUM), Education
- Keywords
- Sarcopenia, Functional magnetic stimulation
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Nutritional supplementation (ENSURE HIGH CALCIUM)Dietary supplement
The nutritional supplementation includes 7 cans of "ENSURE HIGH CALCIUM" per week for 8 consecutive weeks.
EducationBehavioural
The education includes a DVD and one session of oral instructions on general care and exercise suggestions for sarcopenia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
We use dual energy x-ray absorptiometry to evaluate the muscle mass (kg/m2) in the subjects.
Measured: Before the intervention, and 1-2 weeks after the 8-week intervention
Handgrip strength
We use a dynamometer to measure the handgrip strength (kg)
Measured: 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.
Measured: 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.
Measured: Before the intervention, and 1-2 weeks after the 8-week intervention
Secondary outcomes (5)
Leg circumference
We measure the largest calf circumference with seated position with knee flexed in 90 degrees.
Measured: Before the intervention, and 1-2 weeks after the 8-week intervention
Cytokines related to sarcopenia
We will check the concentrations of cytokines including the c-reactive protein from our subjects.
Measured: Before the intervention, and 1-2 weeks after the 8-week intervention
Nutritional status
We use the questionnaire Mini Nutritional Assessment to evaluate the subjects' nutritional status.
Measured: Before the intervention, and 1-2 weeks after the 8-week intervention
Activity level
We use the International Physical Activity Questionnaire to evaluate the subjects' activity levels.
Measured: Before the intervention, and 1-2 weeks after the 8-week intervention
Life quality
We use the EuroQol-5 dimensions (EQ-5D) and Taiwan Short Form-36 questionnaires to evaluate the subjects' health life quality.
Measured: Before the intervention, and 1-2 weeks after the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shao-Yu Chi, Principal investigator, National Taiwan University Hospital Beihu Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182020
- Sponsor's protocol ID
- 202309121RIND
- Status last verified
- Nov 2023
- First submitted
- 23 Nov 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Integrated Care Involving Peripheral Functional Magnetic Stimulation and Nutritional Supplement for Age-related Sarcopenia
- ClinicalTrials.gov ID
- NCT06182020
- Acronym / sponsor ID
- 202309121RIND
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Functional magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated care | Experimental | Device: Peripheral functional magnetic stimulation (ISKRA MEDICAL TESLA Former prestige Magneto therapy), Dietary Supplement: Nutritional supplementation (ENSURE HIGH CALCIUM)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. |
| Usual care | Active comparator | Behavioral: EducationParticipants in this group will receive an educational DVD and one session of oral instructions on general care and exercise suggestions for sarcopenia. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- Cognitive impairment
- History of cerebrovascular disease
- Deep vein thrombosis
- Malignancy under treatment
- Coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Integrated care |
| Nutritional supplementation (ENSURE HIGH CALCIUM)The nutritional supplementation includes 7 cans of "ENSURE HIGH CALCIUM" per week for 8 consecutive weeks. | Dietary supplement | Integrated care |
| EducationThe education includes a DVD and one session of oral instructions on general care and exercise suggestions for sarcopenia. | Behavioural | Usual care |
Primary outcome
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.
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.
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.
5 secondary outcomes
Leg circumference
Time frame: Before the intervention, and 1-2 weeks after the 8-week intervention
Cytokines related to sarcopenia
Time frame: Before the intervention, and 1-2 weeks after the 8-week intervention
Nutritional status
Time frame: Before the intervention, and 1-2 weeks after the 8-week intervention
Activity level
Time frame: Before the intervention, and 1-2 weeks after the 8-week intervention
Life quality
Time frame: Before the intervention, and 1-2 weeks after the 8-week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shao-Yu Chi principal investigator
National Taiwan University Hospital Beihu Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral functional magnetic stimulation (ISKRA MEDICAL TESLA Former prestige Magneto therapy), Nutritional supplementation (ENSURE HIGH CALCIUM) and Education in people with Sarcopenia, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shao-Yu Chi (+886972653975, shaoyuchi.tw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: Before the intervention, and 1-2 weeks after the 8-week intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.