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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006481
Receipt No. R000007678
Scientific Title Effects of supervised exercise therapy and non-supervised exercise therapy for patients with arteriosclerosis obliterans after intravascular intervention.
Date of disclosure of the study information 2011/10/13
Last modified on 2014/04/19

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Basic information
Public title Effects of supervised exercise therapy and non-supervised exercise therapy for patients with arteriosclerosis obliterans after intravascular intervention.
Acronym Effects of exercise therapy for patients with arteriosclerosis obliterans.
Scientific Title Effects of supervised exercise therapy and non-supervised exercise therapy for patients with arteriosclerosis obliterans after intravascular intervention.
Scientific Title:Acronym Effects of exercise therapy for patients with arteriosclerosis obliterans.
Region
Japan

Condition
Condition arteriosclerosis obliterans
Classification by specialty
Medicine in general Cardiology Vascular surgery
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate effects of exercise therapy along with intravascular intervention for arteriosclerosis obliterans.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1, Evaluation of intermittent claudication (treadmill exercise test, six-minutes walk distance)
2, subjective symptoms (SF36, WIQ score)
3, Ankle brachial index
4, Intima media thickness of the carotid artery
5, flow mediated vasodilatation
6, Labo data (coronary risk factors, oxidative stress, and other biomarkers)
7, Whether unfortunate events occured; all death, acute myocardiac infarction, coronary intervention, peripheral intervention, cerebrovascular disease, bleeding complications and other adverse events.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Supervised exercise therapy
Interventions/Control_2 Non-supervised exercise therapy
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 Patients with arteriosclerosis obliterans who have intermittent claudication with the indication of intravascular intervention.
Key exclusion criteria Patients were excluded if they were:
on chronic hemodialysis.
with severe coronary artery stenosis.
Breast-feeding women or with a chance of pregnancy.
with side effects of antiplatelets.
with severe liver and/or renal dysfunction.
with malignant disease in the past five years.
with reflactory ulcer.
not able to walk because of orthopedic disease or others.
with diabetic proliferative retinopathy.
not recommended for exercise therapy according to based on the Japanese guideline of cardiac rehabilitation.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Saeko Yamasaki
Organization Shinshu University Hospital
Division name Department of cardiology
Zip code
Address 3-1-1, Asahi, Matsumoto, Nagano
TEL 0263-37-3486
Email saeko@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Saeko Yamasaki
Organization Shinshu University Hospital
Division name Department of cardiology
Zip code
Address 3-1-1, Asahi, Matsumoto, Nagano
TEL 0263-37-3486
Homepage URL
Email saeko@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Shinshu University
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
Address
Tel
Email

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 信州大学医学部附属病院(長野県)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 13 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
2011 Year 10 Month 13 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 04 Month 19 Day
Date trial data considered complete
2014 Year 04 Month 19 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 05 Day
Last modified on
2014 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007678

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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