UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028361