UMIN-CTR Clinical Trial

Basic information
Public title	Can muscle damage induced by long-time stretches provide protective effect?
Acronym	Can long-time stretches provide muscular protective effect?
Scientific Title	Can muscle damage induced by long-time stretches trigger the repeated bout effect?
Scientific Title:Acronym	Can long-time stretches provide the repeated bout effect?
Region	Japan

Condition
Condition	Exercise-induced muscle damage
Classification by specialty	Surgery in general Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verifying that stretching prevents exercise-induced muscle damage
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intermediary before, after, 24, 48 and 72 h stretching Creatine kinase Titin N-terminal fragment Maximum voluntary isometric contraction Range of motion
Key secondary outcomes	Swelling Muscle soreness

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Equipment: BIODEX Intensity 1: Passive torque 45 Nm Duration: 10 min Subjective muscle: Knee flexor
Interventions/Control_2	Equipment: BIODEX Intensity 1: Passive torque 55 Nm Duration: 10 min Subjective muscle: Knee flexor
Interventions/Control_3	Equipment: BIODEX Intensity 3: Passive torque 65 Nm Duration: 10 min Subjective muscle: Knee flexor
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	18 years-old <=
Age-upper limit	30 years-old >=
Gender	Male and Female
Key inclusion criteria	Persons who do not apply the exclusion criteria
Key exclusion criteria	Person who regularly performs strength training Person with hip joint flexion angle of 120 degrees or more due to long seat forward bending Persons taking supplements.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Junichi Middle name Last name Okada
Organization	Waseda university
Division name	Faculty of sport science
Zip code	3591192
Address	2-579-15 Mikajima, Tokorozawa, Saitama
TEL	08030438030
Email	kato@yahoo.co.jp

Public contact
Name of contact person	1st name Shota Middle name Last name kato
Organization	Waseda university
Division name	Sport science graduate course
Zip code	202-0021
Address	2-7-5 higashifushimi, Nishi tokyo, Tokyo
TEL	08030438030
Homepage URL
Email	kato@yahoo.co.jp

Sponsor
Institute	Waseda university
Institute
Department

Funding Source
Organization	Non available
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	Waseda university
Address	2-579-15 Mikajima, Tokorozawa, Saitama
Tel	04-2947-6848
Email	webmaster19@list.waseda.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	2020 Year 01 Month 12 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	2020 Year 02 Month 15 Day
Date of IRB	2019 Year 12 Month 20 Day
Anticipated trial start date	2020 Year 03 Month 01 Day
Last follow-up date	2021 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 12 Day
Last modified on	2021 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044379