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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name