UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001372 |
|---|---|
| Receipt number | 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 20:40:16 |
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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
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
shimike@luke.or.jp
Sponsor or person
Institute
St. Lukes International Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001663
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