UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036728 |
|---|---|
| Receipt number | R000041845 |
| Scientific Title | Investigation into about the injury prevention method by the technique of the sports medicine for athletes, performing artists: open-label, non-randomized, single group assignment, time series designed trial. |
| Date of disclosure of the study information | 2019/05/13 |
| Last modified on | 2023/06/08 14:17:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation into about the injury prevention method by the technique of the sports medicine for athletes, performing artists
Acronym
Injury prevention research by the technique of the sports medicine
Scientific Title
Investigation into about the injury prevention method by the technique of the sports medicine for athletes, performing artists: open-label, non-randomized, single group assignment, time series designed trial.
Scientific Title:Acronym
Injury prevention research by the technique of the sports medicine:open-label, single group assignment, time series designed trial.
Region
| Japan |
Condition
Condition
Healthy general population in physical activity and sport.
Classification by specialty
| Orthopedics | Rehabilitation medicine | Not applicable |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We set questionnaires necessary for stress, fatigue evaluations and the questionnaire which are necessary for an evaluation about performance. And we analyze mental and physical abnormality from saliva tests and clarify mechanism under the stress situation. In addition, we perform biochemical tests under the special environment and a simple evaluation judging method, and the evaluation of the exercise function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Physiologic evaluation
2) Extracting question items, inspection items. An original index, evaluation.
3) Physical exercise usability tests.
4) Stress, and Fatigue evaluation (biochemical evaluation).
Key secondary outcomes
Mind and body health care evaluation, the medical approach to sports players, the establishment of the general evaluation method about the treatment.
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
We research psychological and physical questionnaires and injuries tests of participants at the normal exercise day and the stressful events under pressure day, with psychology, physiology and biochemical investigations.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy population in physical activity and sport.
Key exclusion criteria
1)The Participant who came to have difficulty with continuation by themselves.
2)In addition, the participant whom it was a judged a researcher to be inappropriate.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Fujiya |
Organization
St. Marianna University School of Medicine
Division name
Department of Sports Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyame-ku, Kawasaki city
TEL
044-977-8111
fujiya-1487@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Kanaka |
| Middle name | |
| Last name | Yatabe |
Organization
St. Marianna University School of Medicine
Division name
Dept. of Sports Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyame-ku, Kawasaki city
TEL
+81-44-977-8111
Homepage URL
fujiya-1487@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
MEXT in Japan
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyame-ku, Kawasaki city
Tel
044-977-8111
k-sienbu.mail@marianna-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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 13 | 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
100
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
Suspended
Date of protocol fixation
| 2009 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2009 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2030 | 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 | 05 | Month | 13 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041845
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
