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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032135
Receipt No. R000036649
Scientific Title The effect of age and exercise on muscle function
Date of disclosure of the study information 2018/04/21
Last modified on 2019/05/31

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Basic information
Public title The effect of age and exercise on muscle function
Acronym The effect of age and exercise on muscle function
Scientific Title The effect of age and exercise on muscle function
Scientific Title:Acronym The effect of age 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 To evaluate the effect of exercise on muscle function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measured value of quadriceps cross-sectional area at 24th week of exercise
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Middle-load exercise for 24 weeks
Interventions/Control_2 Low-load exercise for 24 weeks
Interventions/Control_3 No exercise for 24 weeks
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
50 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria 1) Women and men aged 50 to 79 years at the time of acquisition of agreement in participating in this study
2) Person who does not engage regular exercise.
3) Person who can come to the medical organization for the measurement at the date of visiting
4) 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 of disease in locomotor organs affecting the efficacy assessment of this study.
2) Presence of health problems to perform exercise.
3) Use of product affecting the data of this study, such as medicine, food for specified health use, supplement, diet food.
4) With previous and present serious disease such as cardiac affection, liver disorder, kidney disorder, cardiovascular disorder, lung disorder, diabetes mellitus.
5) Investigator's judgment for other reason.
Target sample size 54

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Izumo
Organization Suntory Wellness Limited
Division name Institute For Health Care Science
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, 619-0284, Japan
TEL 050-3182-0630
Email Takayuki_Izumo@suntory.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuta Otsuka
Organization Suntory Wellness Limited
Division name Institute For Health Care Science
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, 619-0284, Japan
TEL 050-3182-0671
Homepage URL
Email Yuta_Otsuka@suntory.co.jp

Sponsor
Institute Suntory Wellness Limited
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
2018 Year 04 Month 21 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 04 Month 05 Day
Date of IRB
2018 Year 04 Month 04 Day
Anticipated trial start date
2018 Year 04 Month 21 Day
Last follow-up date
2019 Year 05 Month 31 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 06 Day
Last modified on
2019 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036649

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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