UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032279
Receipt No. 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 2018/04/17

* 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 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
Middle name
Last name Tomohiro Sugino
Organization Soiken Inc.
Division name R&D Division
Zip code
Address Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL 06-6871-8888
Email sugino@soiken.com

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Sugino
Organization Soiken Inc.
Division name Representative Director
Zip code
Address Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL 06-6871-8888
Homepage URL
Email sugino@soiken.com

Sponsor
Institute Soiken Inc.
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 17 Day
Last follow-up date
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
2018 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036809

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.