UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050741 |
|---|---|
| Receipt number | R000057762 |
| Scientific Title | Inspection of the multifaceted effect of Electrical Muscle Stimulation (EMS) in patients with type 2 diabetes |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2024/12/24 18:23:18 |
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Basic information
Public title
Inspection of the multifaceted effect of Electrical Muscle Stimulation (EMS) in patients with type 2 diabetes
Acronym
Inspection of the multifaceted effect of Electrical Muscle Stimulation in patients with type 2 diabetes
Scientific Title
Inspection of the multifaceted effect of Electrical Muscle Stimulation (EMS) in patients with type 2 diabetes
Scientific Title:Acronym
Inspection of the multifaceted effect of Electrical Muscle Stimulation (EMS) in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Continuation of exercise therapy may become difficult in elderly people because of the ADL down by decreased skeletal muscle mass. In late years electrical stimulation in Electrical Muscle Stimulation (EMS) attracts attention as a new exercise therapy. The purpose of this study is to clarify the various effects such as glycemic control, body weight, body composition, leg muscular strength, muscle mass, balance function, serum lipid, QOL and ADL by daily EMS in old and sarcopenic diabetic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscular strength and quantity of the lower leg
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients use Foot Fit 2 against lower leg muscles once or twice a day for 3 months.
Interventions/Control_2
Patients perform normal life for 3 month.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients with lower mauscle mass compared to average of the same age.
Key exclusion criteria
1. Patient with severe diabetic neuropathy
2. Patient with sever visual disorder
3. Patient with hemodialysis
4. Patient with severe cardiovascular disorder like myocardial infarction
5. Patient with phlebothrombosis or injury of the foot bottom
6. Patient using pacemaker
7. Patient with malignancy or epilepsy
8. Patient with high HbA1c (>= 11%) or difficulty of sitting more than 30 minutes
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ueno |
Organization
Faculty of Internal Medicine, University of Miyazaki
Division name
Division of Hematology, Diabetes, and Endocrinology, Department of Internal Medicine
Zip code
889-1692
Address
5200, Kihara , Kiyotake, Miyazaki, Japan
TEL
+85-985-85-9121
intron@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ueno |
Organization
Faculty of Internal Medicine, University of Miyazaki
Division name
Division of Hematology, Diabetes, and Endocrinology, Department of Internal Medicine
Zip code
889-1692
Address
5200, Kihara , Kiyotake, Miyazaki, Japan
TEL
+85-985-85-9121
Homepage URL
intron@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Miyazaki University
Institute
Department
Personal name
Funding Source
Organization
Miyazaki University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miyazaki University
Address
5200, Kihara , Kiyotake, Miyazaki, Japan
Tel
+85-985-85-1510
rinken@med.miyazaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
25
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 31 | Day |
Last modified on
| 2024 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057762
