UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029366 |
|---|---|
| Receipt number | R000033478 |
| Scientific Title | A study on physical activity, walking maintenance and prognosis by the severity of peripheral artery disease |
| Date of disclosure of the study information | 2017/10/03 |
| Last modified on | 2021/04/08 21:30:23 |
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Basic information
Public title
A study on physical activity, walking maintenance and prognosis by the severity of peripheral artery disease
Acronym
A study on physical activity, walking maintenance and prognosis by the severity of peripheral artery disease
Scientific Title
A study on physical activity, walking maintenance and prognosis by the severity of peripheral artery disease
Scientific Title:Acronym
A study on physical activity, walking maintenance and prognosis by the severity of peripheral artery disease
Region
| Japan |
Condition
Condition
peripheral arterial disease
Classification by specialty
| Cardiology | Vascular surgery | Plastic surgery |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the relation peripheral arterial disease and the amount of activity, prognosis, walking retention rate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoints are difference between the PAD severity (Fontaine 2 and 3-4) of the change in the physical activity amount at the beginning of the study and 21 months after discharge.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
PAD patients
1. Patients who are no less than 20 years old.
2. Ambulatory patients
Key exclusion criteria
1. Patients taken a major amputation or taking a major amputation in this therapy.
2. Patients don't go to hospital for study
3. Women who are pregnant or hope to become pregnant during the study period.
4. Patients judged inappropriate for the study by their physicians.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Terabe |
| Middle name | |
| Last name | Yuta |
Organization
Kasukabe chuo general hospital
Division name
Limb Salvage center
Zip code
344-0063
Address
midori5-9-4, Kasukabe, Saitama
TEL
0487361221
k.sk.tera@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Terabe |
Organization
Kasukabe chuo general hospital
Division name
Limb Salvage center
Zip code
344-0063
Address
midori5-9-4, Kasukabe, Saitama
TEL
0487361221
Homepage URL
k.sk.tera@gmail.com
Sponsor or person
Institute
Kasukabe Chuo General Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Kasukabe Chuo General Hospital
Address
midori5-9-4, Kasukabe, Saitama
Tel
0487361221
k.sk.tera@gmail.com
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
| 2017 | Year | 10 | Month | 03 | 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
| 2017 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
multi-center prospective cohort study
Management information
Registered date
| 2017 | Year | 10 | Month | 01 | Day |
Last modified on
| 2021 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033478
