UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044739 |
|---|---|
| Receipt number | R000049335 |
| Scientific Title | Influence of the exercise habit and aging on the morphological and functional properties of the fascia |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2021/07/02 14:23:43 |
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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
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
ootsuka.shun.889@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi medical university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049335
