UMIN-CTR Clinical Trial

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
Email	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
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	IRB of Fukuda Clinic
Address	Shin-Osaka Brick Building 2F, 1-6-1, Miyahara, Yodogawa-ku, Osaka, Osaka
Tel	06-6398-0203
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036809