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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001372
Receipt No. R000001663
Scientific Title Effects of exercise rihabilitation for patients with PAD(Peripheral arterial disease).
Date of disclosure of the study information 2008/09/12
Last modified on 2008/09/12

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Basic information
Public title Effects of exercise rihabilitation for patients with PAD(Peripheral arterial disease).
Acronym Effects of exercise rihabilitation for patients with PAD(Peripheral arterial disease).
Scientific Title Effects of exercise rihabilitation for patients with PAD(Peripheral arterial disease).
Scientific Title:Acronym Effects of exercise rihabilitation for patients with PAD(Peripheral arterial disease).
Region
Japan

Condition
Condition Peripheral arterial disesase
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the effectiveness of the exercise rihabilitation for patients with peripheral arterial disease.
Patients are randomely enrolled to either the treadmill or the elgomater exercise group. The exercise are planned to be carried out one a week for 30 minutes for 3 months.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)Evaluation of the severity of intermittend claudication
2)ICD(initial claudication distance),ACD(absolute claudication distance)
3)ABI,TBI,PWV
4)QOL(SF36,WIQ score)
5)SPP(skin perfusion pressure)
6)IMT
7)Labo data(WBC,Alb,BUN,Cre,LDL-chol,HDL-chol,TG,UA,High sense CRP,AST,ALT,LDH,T-Bil,CK,HbA1c,BNP,homocysteine,fibrinogen,D-dimer,U-pro,U-micro alb,U-UN,U-Cre)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 treadmill group
Interventions/Control_2 ergometer group
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with peripheral arterial disease which was established by angiography, MDCT or vascular echo and have intermittend claudication.
We don't consider whether patients have a history of revasulization therapy or not.
Patients received the education of life style modification.
Key exclusion criteria Patients cannot do treadmill exersize test, for exanmple of CLI(critical limb ischemia).
Patients who have severe heart diseases (LV dysfunction (EF less than 35%, severe ischemic heart disease and valvelar heart disease)).
Patients who have severe comorbidities.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kuwabara Masanari
Organization St. Lukes International Hospital
Division name division of residency
Zip code
Address 9-1 Akashi-cho, Tyuuou-ku, Tokyo
TEL 03-3541-5151
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization St. Lukes International Hospital
Division name division of reseach administration
Zip code
Address
TEL 03-3541-5151
Homepage URL
Email shimike@luke.or.jp

Sponsor
Institute St. Lukes International Hospital
Institute
Department

Funding Source
Organization St. Lukes International Hospital
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

Other administrative information
Date of disclosure of the study information
2008 Year 09 Month 12 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
Date of protocol fixation
2008 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2008 Year 12 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
2008 Year 09 Month 12 Day
Last modified on
2008 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001663

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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