UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055351 |
|---|---|
| Receipt number | R000063256 |
| Scientific Title | Analysis of NMES Effects Using Urinary Exosome Protein Analysis |
| Date of disclosure of the study information | 2024/08/28 |
| Last modified on | 2024/08/28 00:13:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Analysis of NMES Effects Using Urinary Exosome Protein Analysis
Acronym
Analysis of NMES Effects Using Urinary Exosome Protein Analysis
Scientific Title
Analysis of NMES Effects Using Urinary Exosome Protein Analysis
Scientific Title:Acronym
Analysis of NMES Effects Using Urinary Exosome Protein Analysis
Region
| Japan |
Condition
Condition
Osteoarthritis of the Knee and Osteoarthritis of the Hip
Classification by specialty
| Medicine in general | Geriatrics | Orthopedics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The decline in muscle strength is closely related to the onset of sarcopenia in the elderly, where restricted activity leads to a significant reduction in muscle strength and mass, resulting in a high prevalence of sarcopenia. Therefore, preventing muscle strength decline and treating sarcopenia are crucial challenges that contribute to improving the quality of life and prognosis in the elderly. Resistance exercise effectively maintains and increases muscle strength, but starting and continuing exercise can be challenging for older adults. As a solution, non-invasive neuromuscular electrical stimulation (NMES) has proven effective in promoting muscle hypertrophy and the secretion of myokines. However, the specific physiological and biological mechanisms of NMES and how changes in urinary exosome proteins reflect the effects of exercise intervention remain unclear. This study aims to investigate the effects of an exercise program incorporating NMES on patients undergoing outpatient exercise rehabilitation for knee or hip osteoarthritis, through the analysis of urinary exosomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of Urinary Exosomes: The analysis of proteins within the isolated exosomes will focus on the expression levels of Parkin, a key regulator of mitophagy; GDF-8, which functions as a negative regulator of muscle growth; and Activin II receptor, expected to be expressed on the outer membrane of exosomes and reflect the condition of skeletal muscle, both before and after NMES.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Neuromuscular electrical stimulation
Interventions/Control_2
control
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women aged 50 and above attending outpatient rehabilitation at the Owl Clinic Jiyugaoka
Patients undergoing outpatient musculoskeletal rehabilitation as a treatment for their underlying condition
Undergoing musculoskeletal rehabilitation for osteoarthritis of the knee and osteoarthritis of the hip
Started outpatient rehabilitation within the last six months
Key exclusion criteria
Patients currently undergoing treatment for malignant tumors (a history of malignancy is not an issue).
Patients with severe diabetes (complications such as retinopathy, fundus hemorrhage, dialysis, or peripheral neuropathy).
Patients with severe heart disease (e.g., in the ultra-acute phase of acute myocardial infarction, those with a pacemaker, unstable angina, poorly controlled heart failure, advanced obstructive hypertrophic cardiomyopathy, acute embolism, or acute infections such as pericarditis or myocarditis).
Patients with severe dementia who cannot follow instructions.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | mitsuo |
| Middle name | |
| Last name | hashimoto |
Organization
Nippon Sport Science University
Division name
Faculty of Sport Science, Department of Health Science
Zip code
1580081
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
TEL
03-5706-0862
mitsuo-hashimoto@nittai.ac.jp
Public contact
Name of contact person
| 1st name | mitsuo |
| Middle name | |
| Last name | Hashimoto |
Organization
Nippon Sport Science University
Division name
Faculty of Sport Science, Department of Health Science
Zip code
1580081
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
TEL
03-5706-0862
Homepage URL
mitsuo-hashimoto@nittai.ac.jp
Sponsor or person
Institute
Nippon Sport Science University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
Nippon Sport Science University
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
Tel
03-5706-0900
mitsuo-hashimoto@nittai.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
| 2024 | Year | 08 | Month | 28 | 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
| 2024 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 08 | 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 | 08 | Month | 28 | Day |
Last modified on
| 2024 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063256
