UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021270 |
|---|---|
| Receipt number | R000024535 |
| Scientific Title | The effect of medical checkup and physical conditioning training for runners and walkers on running and walking performance |
| Date of disclosure of the study information | 2016/03/02 |
| Last modified on | 2019/09/04 10:04:07 |
* 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
The effect of medical checkup and physical conditioning training for runners and walkers on running and walking performance
Acronym
The effect of physical conditioning training on running performance
Scientific Title
The effect of medical checkup and physical conditioning training for runners and walkers on running and walking performance
Scientific Title:Acronym
The effect of physical conditioning training on running performance
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of medical checkup and physical conditioning training by medical doctors and athletic trainers on running and walking performance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of running or walking performance 6-12 months after instruction. Running or walking performance will be evaluated by running or walking economy calculated from oxygen uptake, speed, and distance that will be measured using cardiopulmonary exercise testing.
Key secondary outcomes
maximum oxygen uptake, muscle strength, body composition, pain due running or walking injuries, balance function
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The subject are going to receive medical checkup by doctors and instruction of physical conditioning training by athletic trainers for 6 to 12 months.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Male or female runner or walker of more than 20 years.
Key exclusion criteria
Subject who can not participate in the instruction of physical conditioning training safely due to known illness, injuries, or mental disorders will be excluded.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Matsumoto |
Organization
Keio University School of Medicine
Division name
nstitute for Integrated Sports Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
m-hideo@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Tabata |
Organization
Keio University School of Medicine
Division name
nstitute for Integrated Sports Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
sky_walker_590718@yahoo.co.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Institute for Integrated Sports Medicine, School of Medicine, Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 03 | Month | 02 | 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
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 01 | Day |
Last modified on
| 2019 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024535
