UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053443 |
|---|---|
| Receipt number | R000060991 |
| Scientific Title | Effect validation of skeletal muscle electrical stimulation for older patients with sarcopenia; Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/01/25 17:36:07 |
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Basic information
Public title
Effect validation of skeletal muscle electrical stimulation for elderly patients with sarcopenia
Acronym
Effect validation of skeletal muscle electrical stimulation for elderly patients with lower physical function
Scientific Title
Effect validation of skeletal muscle electrical stimulation for older patients with sarcopenia; Randomized Controlled Trial
Scientific Title:Acronym
Effect validation of skeletal muscle electrical stimulation for older patients with sarcopenia
Region
| Japan |
Condition
Condition
Older patients with sarcopenia hospitalized in convalescent rehabilitation ward
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of electrical stimulation of skeletal muscle on body composition and physical function in older patients with sarcopenia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skeletal muscle mass index
Key secondary outcomes
Functional Independence Measure
Knee extension strength
Hand grip strength
Short Physical Performance Battery
Walking speed
6 minute walking distance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Electrical muscular stimulation condition for lower extremity (7 times a week, 20 minutes each session, for 4 continuous weeks)
Interventions/Control_2
Normal exercise therapy such as joint range of motion exercises, muscle strength exercises, aerobic exercises, activities of daily living exercises, walking exercises, etc.
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
Patients aged 65 years and more with sarcopenia and admitted to Nishi-Kinen Port Island Rehabilitation Hospital for rehabilitation purposes.
Key exclusion criteria
1) Patients with non-independent ambulation before the onset
2) Patients with inability to measure body composition (e.g., pacemakers, loss of limbs)
3) Patients with difficulty in holding a standing position on their-self due to disease-specific symptoms and diseases with myositis
4) Patients who are unable to cooperate in the evaluation (cognitive dysfunction, higher brain dysfunction, consciousness disorder)
5) Patients with inability to give consent for this study
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Takuro |
| Middle name | |
| Last name | Ohtsubo |
Organization
Nishi-Kinen Port Island Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
650-0046
Address
8-5-2, Minatojima-nakamachi, Chuo-ku, Kobe, Hyogo
TEL
078-303-2424
takuro.otsubo@gmail.com
Public contact
Name of contact person
| 1st name | Takuro |
| Middle name | |
| Last name | Ohtsubo |
Organization
Nishi-Kinen Port Island Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
650-0046
Address
8-5-2, Minatojima-nakamachi, Chuo-ku, Kobe, Hyogo
TEL
078-303-2424
Homepage URL
takuro.otsubo@gmail.com
Sponsor or person
Institute
Nishi-Kinen Port Island Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kobe Gakuin University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nishi-Kinen Port Island Rehabilitation Hospital
Address
8-5-2, Minatojima-nakamachi, Chuo-ku, Kobe, Hyogo
Tel
078-303-2424
takuro.otsubo@gmail.com
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
西記念ポートアイランドリハビリテーション病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | 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
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
Preinitiation
Date of protocol fixation
| 2003 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2024 | Year | 01 | Month | 25 | Day |
Last modified on
| 2024 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060991
| Research Plan | |
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| Registered date | File name |
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