UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016524 |
|---|---|
| Receipt number | R000019189 |
| Scientific Title | Impact of comprehensive cardiac rehabilitation program on a quantitative and qualitative change in a leg skeletal muscle and exercise tolerance with peripheral arterial disease |
| Date of disclosure of the study information | 2015/03/08 |
| Last modified on | 2019/08/18 16:55:03 |
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Basic information
Public title
Impact of comprehensive cardiac rehabilitation program on a quantitative and qualitative change in a leg skeletal muscle and exercise tolerance with peripheral arterial disease
Acronym
Impact of comprehensive cardiac rehabilitation program on a quantitative and qualitative change in a leg skeletal muscle and exercise tolerance with peripheral arterial disease
Scientific Title
Impact of comprehensive cardiac rehabilitation program on a quantitative and qualitative change in a leg skeletal muscle and exercise tolerance with peripheral arterial disease
Scientific Title:Acronym
Impact of comprehensive cardiac rehabilitation program on a quantitative and qualitative change in a leg skeletal muscle and exercise tolerance with peripheral arterial disease
Region
| Japan |
Condition
Condition
Peripheral Arterial Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Present study is to observe impact of comprehensive cardiac rehabilitation program on a quantitative and qualitative change in a leg skeletal muscle and exercise tolerance with peripheral arterial disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of quantitative and qualitative in a leg skeletal muscle after comprehensive cardiac rehabilitation program
Key secondary outcomes
Exercise tolerance
The vascular endothelium function
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
comprehensive cardiac rehabilitation program
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
Peripheral arterial disease with Fontaine II
Key exclusion criteria
Patient who is impossible to exercise
Patient who judged that examination responsibility doctor is improper as object in present study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Yokoyama |
Organization
Juntendo University, Graduate School of medicine
Division name
Department of cardiovascular medicine
Zip code
113-8431
Address
2-1-1, Hongo, Bunkyo-ku Tokyo Japan
TEL
03-3813-3111
mipocch@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Yokoyama |
Organization
Juntendo University, Graduate School of medicine
Division name
Department of cardiovascular medicine
Zip code
113-8431
Address
2-1-1, Hongo, Bunkyo-ku Tokyo Japan
TEL
03-3813-3111
Homepage URL
mipocch@juntendo.ac.jp
Sponsor or person
Institute
Department of cardiology, Juntendo University, Graduate School of medicine
Institute
Department
Personal name
Funding Source
Organization
The Japanese Association of Cardiac Rehabilitation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Juntendo University Ethics Committee
Address
3-1-3, Hongo, Bunkyo-ku Tokyo Japan
Tel
03-3813-3111
chiken@juntendo.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
順天堂大学医学部附属順天堂医院(東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 12 | Day |
Last modified on
| 2019 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019189
