UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032279 |
|---|---|
| Receipt number | R000036809 |
| Scientific Title | A preliminary to investigate the effect of aging and exercise on muscle function |
| Date of disclosure of the study information | 2019/04/18 |
| Last modified on | 2019/10/18 11:38:44 |
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Basic information
Public title
A preliminary to investigate the effect of aging and exercise on muscle function
Acronym
A preliminary to investigate the effect of aging and exercise on muscle function
Scientific Title
A preliminary to investigate the effect of aging and exercise on muscle function
Scientific Title:Acronym
A preliminary to investigate the effect of aging and exercise on muscle function
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Inspection and confirmation of the procedure for conducting a clinical study to investigate the effects of aging and exercise on muscle function
Basic objectives2
Others
Basic objectives -Others
Confirmation of the procedure
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
None
Key secondary outcomes
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Middle-load exercise for a day
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
| 60 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Healthy women and men aged 60 to 79 years at the time of acquisition of agreement in participating in this study
2)Person who can understand the purpose and content of this study and agree in writing to participate in this study
Key exclusion criteria
1)Presence or having a history of severe liver failure, cardiovascular disturbance, respiration disorder, endocrine disorder or metabolic disturbance
2)Presence of motor system's disease that affects implementation of the exercise
3)Inability to exercise because of the symptom or disease of joint system and muscle system, or having difficulty in daily living activity or walking or inability to exercise because of severe pain of the knee or the back
4)There is a possibility to recrudesce of motor system's anamnesis such as lumbago, due to the exercise
5)3 months before the start of the study, Presence of diseases related to bone or joint or muscle, such as fracture, sprain and muscle strain
6)Presence of circulatory disease that affects implementation of the exercise
7)Drinking alcohol 60 g or over a day
8)Smoking over 20 cigarettes a day
9)In screening, systolic blood pressure is 160 mmHg or over, or diastolic blood pressure is 100 mmHg or over
10)Investigator's judgment for other reason
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Sugino |
Organization
Soiken Inc.
Division name
R&D Division
Zip code
560-0082
Address
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL
0668718888
sugino@soiken.com
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Sugino |
Organization
Soiken Inc.
Division name
Representative Director
Zip code
560-0082
Address
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL
0668718888
Homepage URL
sugino@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
Funding Source
Organization
None
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
IRB of Fukuda Clinic
Address
Shin-Osaka Brick Building 2F, 1-6-1, Miyahara, Yodogawa-ku, Osaka, Osaka
Tel
06-6398-0203
fukudaclinicIRB@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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 18 | 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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 17 | Day |
Last modified on
| 2019 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036809
