UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019755 |
|---|---|
| Receipt number | R000022814 |
| Scientific Title | The examination of the effect for the short time acceleration training on lifestyle-related disease |
| Date of disclosure of the study information | 2015/11/11 |
| Last modified on | 2019/12/02 16:44:57 |
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Basic information
Public title
The examination of the effect for the short time acceleration training on lifestyle-related disease
Acronym
The examination of the effect for the short time acceleration training on lifestyle-related disease
Scientific Title
The examination of the effect for the short time acceleration training on lifestyle-related disease
Scientific Title:Acronym
The examination of the effect for the short time acceleration training on lifestyle-related disease
Region
| Japan |
Condition
Condition
lifestyle-related diseases
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of an effect on lifestyle-related disease of the short acceleration training and body function and the improvement effect
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After six months,
We evaluate a lipid-related item, body function.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The training using the acceleration training machine of 5 min/time, 4 times a week (any day)
Interventions/Control_2
Control
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
The persons with lifestyle-related disease. One of the following standards was reported by a clinical survey and a medical examination
BMI above 25 kg/m2
HDL-cho under 40 mg/dl
LDL-cho above 120 mg/dl
TG above 150 mg/dl
FPG above 100 mg/dl
HbA1c above 5.6 persent
Key exclusion criteria
The patient who has retinal, PDR/PPDR, and the person during the pregnancy and pregnancy applicants
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akihisa |
| Middle name | |
| Last name | Imagawa |
Organization
Osaka Medical College
Division name
Internal medicine I
Zip code
569-8686
Address
2-7, Dagaku-chou, Takatsuki city, Osaka
TEL
072-683-1221
in1337@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Fujisawa |
Organization
Osaka Medical College
Division name
Internal medicine
Zip code
569-8686
Address
2-7, Dagaku-chou, Takatsuki city, Osaka
TEL
072-683-1221
Homepage URL
in1337@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Internal medicine
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
Osaka Medical college
Address
2-7, Dagaku-chou, Takatsuki city, Osaka
Tel
072-683-1221
rinri@art.osaka-med.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
| 2015 | Year | 11 | Month | 11 | 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
23
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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 11 | Day |
Last modified on
| 2019 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022814
