UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054133 |
|---|---|
| Receipt number | R000061463 |
| Scientific Title | Examination of the novel system of Training Device for Elderly People. |
| Date of disclosure of the study information | 2024/05/31 |
| Last modified on | 2025/08/05 09:19:11 |
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Basic information
Public title
Examination of the novel system of Training Device for Elderly People.
Acronym
Examination of the novel system of Training Device for Elderly People.
Scientific Title
Examination of the novel system of Training Device for Elderly People.
Scientific Title:Acronym
Examination of the novel system of Training Device for Elderly People.
Region
| Japan |
Condition
Condition
Healthy elderly people
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the safety of Exercise Coach Muscle Training Device for elderly people.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events
Key secondary outcomes
Muscle strength
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Muscle Strength training using the Exercise Coach muscle training device
Interventions/Control_2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Individuals aged 65 or older but younger than 80 at the time of consent.
(2) Individuals who, within the past 3 months, have consistently demonstrated systolic blood pressure below 150mmHg and diastolic blood pressure below 100mmHg through regular measurements at medical facilities or self-monitoring at home (including those taking antihypertensive medication).
(3) Individuals currently free from symptoms such as joint pain, muscle pain, or bone pain that could affect their ability to exercise.
(4) Individuals who have provided written informed consent for participation in this study of their own free will.
Key exclusion criteria
(1) Individuals currently experiencing musculoskeletal disorders or pain in the musculoskeletal system.
(2) Individuals with a history of myocardial infarction, angina pectoris, heart failure, aortic aneurysm, aortic dissection, or valvular heart disease.
(3) Individuals diagnosed with severe mental disorders requiring treatment (e.g., schizophrenia, severe depression, bipolar disorder) or dementia.
(4) Individuals with significantly impaired basic visual or auditory functions necessary for communication or understanding research instructions.
(5) Individuals with active liver disease or progressive kidney disease (e.g., cirrhosis, chronic renal failure).
(6) Individuals diagnosed with malignant tumors within the past 5 years or currently undergoing treatment, excluding adequately treated non-invasive skin cancers (such as basal cell carcinoma or squamous cell carcinoma).
(7) Individuals diagnosed with substance abuse or alcohol dependence within the past year or currently undergoing treatment.
(8) Other individuals deemed unsuitable for this study by the study personnel.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshitada |
| Middle name | |
| Last name | Sakai |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Rehabilitation Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
0783826826
yossie@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Sakai |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Rehabilitation Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japa
TEL
0783826826
Homepage URL
yossie@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Medicine
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
Tel
0783826826
yossie@med.kobe-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
| 2024 | Year | 05 | Month | 31 | 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
18
Results
No serious adverse events were observed.
Results date posted
| 2025 | Year | 08 | Month | 05 | Day |
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
| 2024 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 07 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 12 | Day |
Last modified on
| 2025 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061463
