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

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 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

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

Value
https://center6.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