UMIN-CTR Clinical Trial

Basic information
Public title	Influence of the exercise habit and aging on the morphological and functional properties of the fascia
Acronym	Influence of the exercise habit and aging on fascia characteristics
Scientific Title	Influence of the exercise habit and aging on the morphological and functional properties of the fascia
Scientific Title:Acronym	Influence of the exercise habit and aging on fascia characteristics
Region	Japan

Condition
Condition	healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of exercise and aging on the human fascia characteristics
Basic objectives2	Others
Basic objectives -Others	To examine the effects of exercise intervention on the human fascia characteristics
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	fascia thickness (2, 4, 6, 8, 10 weeks after starting exercise)
Key secondary outcomes	muscle thickness, subcutaneous adipose tissue thickness, strength (2, 4, 6, 8, 10 weeks after starting exercise)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
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	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	10 weeks of the eccentric knee extension training (twice/week)
Interventions/Control_2
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	20 years-old <=
Age-upper limit	35 years-old >=
Gender	Male and Female
Key inclusion criteria	healthy males and females who have no serious disease, medical history of lower leg and excessive exercise habit
Key exclusion criteria	males and females who have a serious disease, medical history of lower leg and excessive exercise habit
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Shun Middle name Last name Otsuka
Organization	Aichi Medical University School of Medicine
Division name	Department of Anatomy
Zip code	480-1195
Address	1-1 Yazakokarimata, Nagakute, Aichi 480-1195
TEL	0561-62-3311
Email	ootsuka.shun.889@mail.aichi-med-u.ac.jp

Public contact
Name of contact person	1st name Shun Middle name Last name Otsuka
Organization	Aichi Medical University School of Medicine
Division name	Department of Anatomy
Zip code	480-1195
Address	1-1 Yazakokarimata, Nagakute, Aichi 480-1195
TEL	0561-62-3311
Homepage URL
Email	ootsuka.shun.889@mail.aichi-med-u.ac.jp

Sponsor
Institute	Aichi medical university
Institute
Department

Funding Source
Organization	Ministry of education
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)	Tobe maki scholarship foundation

IRB Contact (For public release)
Organization	Aichi Medical University School of Medicine
Address	1-1 Yazakokarimata, Nagakute, Aichi 480-1195
Tel	0561-62-3311
Email	syomu@aichi-med-u.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	愛知医科大学

Other administrative information
Date of disclosure of the study information	2021 Year 08 Month 01 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	Preinitiation
Date of protocol fixation	2021 Year 06 Month 15 Day
Date of IRB	2021 Year 06 Month 21 Day
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2022 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 07 Month 02 Day
Last modified on	2021 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049335