UMIN-CTR Clinical Trial

Basic information
Public title	Effect of stretch exercise on muscle morphology and quality in knee extensors
Acronym	Effect of stretch on muscle morphology and quality
Scientific Title	Effect of stretch exercise on muscle morphology and quality in knee extensors
Scientific Title:Acronym	Effect of stretch on muscle morphology and quality
Region	Japan

Condition
Condition	Healthy people
Classification by specialty	Orthopedics Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To demonstrate an effect of stretching exercise on muscle morphology and quality
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of muscle morphology and quality
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Passively stretching the one side of anterior thigh muscle for 15 seconds three times with 5 seconds interval
Interventions/Control_2	The stretch was not performed on the other side.
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	22 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy people without an exercise habit and who go to work by car
Key exclusion criteria	People who suffered with acute lower extremity injury
Target sample size	28

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koun Yamauchi
Organization	Akita hospital
Division name	Department of orthopedic surgery
Zip code
Address	2-6-12 Takara, Chiryu City, Aichi, Japan
TEL	0566-81-2763
Email	koun_mail_world@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Daisuke Yamada
Organization	Akita hospital
Division name	Research support division
Zip code
Address	2-6-12 Takara, Chiryu City, Aichi, Japan
TEL	0566-81-2763
Homepage URL
Email	sougo@akitahospital.or.jp

Sponsor
Institute	Akita hospital
Institute
Department

Funding Source
Organization	Koun Yamauchi
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	秋田病院（愛知県）/Akita hospital(Aichi)

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 09 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
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 05 Day
Date of IRB
Anticipated trial start date	2018 Year 03 Month 07 Day
Last follow-up date	2018 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date	2018 Year 03 Month 09 Day
Last modified on	2018 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036083

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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