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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024651
Receipt No. R000028361
Scientific Title Development of exercise prescription program for prevention of sarcopenia
Date of disclosure of the study information 2016/10/31
Last modified on 2021/11/04

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Basic information
Public title Development of exercise prescription program for prevention of sarcopenia
Acronym Development of exercise prescription for sarcopenia
Scientific Title Development of exercise prescription program for prevention of sarcopenia
Scientific Title:Acronym Development of exercise prescription for sarcopenia
Region
Japan

Condition
Condition Sarcopenia
Classification by specialty
Medicine in general Cardiology Orthopedics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To develop the exercise prescription program for prevention and treatment both sarcopenia and metabolic syndrome
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Muscle mass, muscle strength and gait speed
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Non intervention
Interventions/Control_2 Exercise
Interventions/Control_3 Diet,
Interventions/Control_4 Exercise+Diet
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Men SMI<7.0
Women SMI<5.4
Key exclusion criteria Stroke, CHD
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Kiyoshi
Middle name
Last name Sanada
Organization Ritsumeikan University
Division name Sport and Health Science
Zip code 525-8577
Address 1-1-1 Nojihigashi, Kusatsu, 525-8577, Japan
TEL 077-561-2674
Email ksanada@fc.ritsumei.ac.jp

Public contact
Name of contact person
1st name Kiyoshi
Middle name
Last name Sanada
Organization Ritsumeikan University
Division name Sport and Health Science
Zip code 525-8577
Address 1-1-1 Nojihigashi, Kusatsu, 525-8577, Japan
TEL 0775612674
Homepage URL
Email ksanada@fc.ritsumei.ac.jp

Sponsor
Institute Ritsumeikan University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ritsumeikan University IRB
Address 1-1-1 Nojihigashi, Kusatsu
Tel 077-599-4175
Email b-rinri@st.ritsumei.ac.jp

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
2016 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Hamaguchi K, Kurihara T, Fujimoto M, Sato K, Iemitsu M, Hamaoka T, Sanada K. International Journal of Environmental Research and Public Health, 2020 Mar; 17(5): E1620.
Nishimura T, Imai A, Fujimoto M, Kurihara T, Kagawa K, Nagata T, Sanada K. Journal of Physical Therapy Science, 2020 Mar; 32(3): pp227-232.
Results date posted
2021 Year 11 Month 04 Day
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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 03 Day
Date of IRB
2011 Year 11 Month 29 Day
Anticipated trial start date
2016 Year 10 Month 31 Day
Last follow-up date
2030 Year 03 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
2016 Year 10 Month 31 Day
Last modified on
2021 Year 11 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028361

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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