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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016524
Receipt No. 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

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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
Email 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
Email mipocch@juntendo.ac.jp

Sponsor
Institute Department of cardiology, Juntendo University, Graduate School of medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019189

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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