UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006481 |
|---|---|
| Receipt number | 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 15:21:28 |
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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
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
saeko@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007678
