UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028237 |
|---|---|
| Receipt number | R000032321 |
| Scientific Title | The study of the profitability and protective effect of cardiac rehabilitation on abdominal aortic aneurysm. |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2019/09/18 09:51:17 |
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Basic information
Public title
The study of the profitability and protective effect of cardiac rehabilitation on abdominal aortic aneurysm.
Acronym
The effects of exercise on AAA
Scientific Title
The study of the profitability and protective effect of cardiac rehabilitation on abdominal aortic aneurysm.
Scientific Title:Acronym
The effects of exercise on AAA
Region
| Japan |
Condition
Condition
abdominal aortic aneurysm
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effects of exercise on AAA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The AAA size 6 months after starting exercise program.
Surgery for AAA.
death
cardiovascular events.
Key secondary outcomes
The biomarker hsCRP, IL-6 and TGF 6 months after starting exercise program.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
cardiac rehabilitation
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
small AAA.
Key exclusion criteria
Marfan symdrome.
infectious aneurysm.
traumatic aneurysm.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Nakayama |
Organization
The university of Tokyo
Division name
Department of cardilology
Zip code
1838655
Address
7-3-1, Hongou, Bunkyou-Ku, Tokyo
TEL
03-3815-5411
st7089-fki@umin.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Nakayama |
Organization
The university of Tokyo
Division name
Department of cardilology
Zip code
1838655
Address
7-3-1, Hongou, Bunkyou-Ku, Tokyo
TEL
03-3815-5411
Homepage URL
st7089-fki@umin.ac.jp
Sponsor or person
Institute
The university of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Grants in aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Commitee of the university of Tokyo hospital
Address
7-3-1 Hongo
Tel
0338155411
st7089-fki@umin.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
| 2017 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
Results
A carefully modified cardiac rehabilitation program that was safely performed with patients with small AAAs protected against AAA expansion and postponed the timing of AAA repair.
Results date posted
| 2019 | Year | 07 | Month | 16 | Day |
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
Main results already published
Date of protocol fixation
| 2004 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2004 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2004 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | 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
| 2017 | Year | 07 | Month | 14 | Day |
Last modified on
| 2019 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032321
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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