UMIN-CTR Clinical Trial

Basic information
Public title	The effects of low-load resistance training with slow movement and tonic force generation on muscle size and physical function in low fitness adults
Acronym	The effects of slow resistance training on muscle size and physical function in low physical fitness adults
Scientific Title	The effects of low-load resistance training with slow movement and tonic force generation on muscle size and physical function in low fitness adults
Scientific Title:Acronym	The effects of slow resistance training on muscle size and physical function in low physical fitness adults
Region	Japan

Condition
Condition	locomotive syndrome
Classification by specialty	Orthopedics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of low-load resistance training with slow movement and tonic force generation on muscle size and physical function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skeletal muscle mass, body composition, muscle strength, muscular power, balance, gait ability, locomotive syndrome resk test
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Low-load resistance training with slow movement and tonic force generation 12 weeks Twice a week
Interventions/Control_2	Normal rehabilitation
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Orthopedic patient who meets all the following criteria: 1) Age 50 or older at the time of consent 2) Subject gives consent in writing to participate in the study 3) Locomotive syndrome risk is level 1 or 2
Key exclusion criteria	1) Subject who is evaluated as inadequate subject by principal or co-principal investigators, or medical doctor because of difficulty of exercise conducting. 2) Subject with problem in cognitive function
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yuya Middle name Last name Watanabe
Organization	Doshisha University
Division name	Facalty of Health and Sports Science
Zip code	610-0394
Address	1-3 Miyakodani Tatara, Kyotanabe City, Kyoto
TEL	0774-65-6720
Email	yuwatana@mail.doshisha.ac.jp

Public contact
Name of contact person	1st name Yuya Middle name Last name Watanabe
Organization	Doshisha University
Division name	Facalty of Health and Sports Science
Zip code	610-0394
Address	1-3 Miyakodani Tatara, Kyotanabe City, Kyoto
TEL	0774-65-6720
Homepage URL
Email	yuwatana@mail.doshisha.ac.jp

Sponsor
Institute	Doshisha University
Institute
Department

Funding Source
Organization	Japanese Society for Musculoskeletal Medicine
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Doshisha University
Address	Karasuma-higashi-iru, Imadegawa-dori, Kamigyo-ku, Kyoto
Tel	075-251-3158
Email	ji-rinri@mail.doshisha.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	2019 Year 03 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	Terminated
Date of protocol fixation	2019 Year 03 Month 19 Day
Date of IRB	2019 Year 06 Month 11 Day
Anticipated trial start date	2019 Year 05 Month 07 Day
Last follow-up date	2022 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	2019 Year 03 Month 19 Day
Last modified on	2021 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041297