UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036920
Receipt number R000041749
Scientific Title Examination for the effects after renal rehabilitation intervention
Date of disclosure of the study information 2019/06/01
Last modified on 2019/06/01 17:12:10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Examination for the effects after renal rehabilitation intervention

Acronym

effects after renal rehabilitation intervention

Scientific Title

Examination for the effects after renal rehabilitation intervention

Scientific Title:Acronym

effects after renal rehabilitation intervention

Region

Japan


Condition

Condition

Chronic renal failure

Classification by specialty

Cardiology Nephrology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We examine how the patients are affected by the exercise therapy during the dialysis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

3m timed up-and-go
At eye opening single leg rising
SF-36
Kt/V
ankle brachial index

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Exercise therapy during the dialysis for 2 years

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

60 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

60 years old and/or older.
It receives maintenance dialysis.
It shows understanding for the exercise therapy during the dialysis.

Key exclusion criteria

It has the orthopedics disease with the trouble for exercise.
It has the internal disorder with the trouble for exercise.
It has the heart disorder with the trouble for exercise.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Tsukasa
Middle name
Last name Yoshimura

Organization

Saiseikai Maebashi Hospital

Division name

Department of Clinical Engineering

Zip code

371-0821

Address

564-1 Kamishinden, Maebashi, Gunma

TEL

0272526011

Email

tsu-yoshimura@maebashi.saiseikai.or.jp


Public contact

Name of contact person

1st name Tsukasa
Middle name
Last name Yoshimura

Organization

Saiseikai Maebashi Hospital

Division name

Department of Clinical Engineering

Zip code

371-0821

Address

564-1 Kamishinden, Maebashi, Gunma

TEL

0272526011

Homepage URL


Email

tsu-yoshimura@maebashi.saiseikai.or.jp


Sponsor or person

Institute

Saiseikai Maebashi Hospital

Institute

Department

Personal name



Funding Source

Organization

none

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

Saiseikai Maebashi Hospital

Address

564-1 Kamishinden, Maebashi, Gunma

Tel

0272526011

Email

tsu-yoshimura@maebashi.saiseikai.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

群馬県済生会前橋病院(群馬県)


Other administrative information

Date of disclosure of the study information

2019 Year 06 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

Preinitiation

Date of protocol fixation

2017 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2019 Year 06 Month 01 Day

Last follow-up date

2024 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 06 Month 01 Day

Last modified on

2019 Year 06 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041749


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name