UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044011
Receipt number R000050223
Scientific Title Large-scale multicenter study to build evidence for physical therapy of diabetes mellitus
Date of disclosure of the study information 2021/05/01
Last modified on 2021/09/22 16:16:03

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Basic information

Public title

Large-scale multicenter study to build evidence for physical therapy of diabetes mellitus

Acronym

Large-scale multicenter study to build evidence for physical therapy of diabetes mellitus

Scientific Title

Large-scale multicenter study to build evidence for physical therapy of diabetes mellitus

Scientific Title:Acronym

Large-scale multicenter study to build evidence for physical therapy of diabetes mellitus

Region

Japan


Condition

Condition

Diabetes mellitus

Classification by specialty

Endocrinology and Metabolism Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to establish a foundation for large-scale clinical research and to obtain evidence in physical therapy for diabetes.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in diabetes-related indices due to physiotherapy

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

30 years-old <=

Age-upper limit

89 years-old >

Gender

Male and Female

Key inclusion criteria

Type 1 and 2 diabetic patients

Key exclusion criteria

1. Gestational diabetic patients
2. Dimentia patients
3. Patients whose daily activities are highly restricted.
4. Patients who seem inappropriate for this study by investigations.

Target sample size

10000


Research contact person

Name of lead principal investigator

1st name Hiroaki
Middle name
Last name Kataoka

Organization

Okayama Healthcare Professional University

Division name

Department of Physical Therapy, Faculty of Health Sciences

Zip code

700-0913

Address

3-2-18, Daiku, Kitaku, Okayama 700-0913, Japan

TEL

086-233-8020

Email

h.kataoka59@gmail.com


Public contact

Name of contact person

1st name Hiroaki
Middle name
Last name Kataoka

Organization

Okayama Healthcare Professional University

Division name

Department of Physical Therapy, Faculty of Health Sciences

Zip code

700-0913

Address

3-2-18, Daiku, Kitaku, Okayama 700-0913, Japan

TEL

086-233-8020

Homepage URL


Email

h.kataoka59@gmail.com


Sponsor or person

Institute

Japanese Society of Physical Therapy for Diabetes Mellitus

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Research Ethics Review Committee of the Japanese Society of Physical Therapy

Address

7-11-10 Roppongi, Minato-ku, Tokyo

Tel

03-5843-1747

Email

ethics@japanpt.or.jp


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

2021 Year 05 Month 01 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

2021 Year 03 Month 09 Day

Date of IRB

2021 Year 03 Month 09 Day

Anticipated trial start date

2021 Year 04 Month 15 Day

Last follow-up date

2030 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Exploratory research


Management information

Registered date

2021 Year 04 Month 22 Day

Last modified on

2021 Year 09 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050223


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name