UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019023
Receipt number R000022002
Scientific Title Effect of exercise rehabilitation for elderly patients on chronic hemodialysis
Date of disclosure of the study information 2015/09/28
Last modified on 2016/03/31 11:57:34

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Basic information

Public title

Effect of exercise rehabilitation for elderly patients on chronic hemodialysis

Acronym

Effect of exercise rehabilitation on chronic hemodialysis

Scientific Title

Effect of exercise rehabilitation for elderly patients on chronic hemodialysis

Scientific Title:Acronym

Effect of exercise rehabilitation on chronic hemodialysis

Region

Japan


Condition

Condition

kidney failure

Classification by specialty

Cardiology Nephrology Geriatrics
Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effect of physical exercise in patients with Kidney Disease on hemodialysis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Lower limb muscle strength
Standing Sitting
CS-30(30-sec Chair stand)
WHO/QOL26
Kt/V

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

3-months of physical exercise in hemodialysis patients.

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

65 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

60 years old or older.
It has a treatment of chronic hemodialysis.
It has shown understanding to exercise therapy in chronic hemodialysis.

Key exclusion criteria

It has orthopedic disease.
It has internal dysfunctions.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yusuke CHIGIRA

Organization

Takasaki University of Health and Welfare

Division name

Faculty of Health Science

Zip code


Address

501 Nakaoorui, Takasakisi, Gunma

TEL

027-352-1291

Email

chigira@takasaki-u.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tukasa yoshimura

Organization

Kan-etsu Central Hospital

Division name

Dialysis room

Zip code


Address

71 Kitahara, Takasakisi, Gunma

TEL

027-373-5115

Homepage URL


Email

chigira@takasaki-u.co.jp


Sponsor or person

Institute

Kan-etsu Central 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


Address


Tel


Email



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

2015 Year 09 Month 28 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

The exercise therapy of between three months for elderly patients of maintenance dialysis, motor function and lower limb muscle strength, QOL was improved.

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

Completed

Date of protocol fixation

2015 Year 05 Month 15 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 01 Day

Last follow-up date

2015 Year 09 Month 30 Day

Date of closure to data entry

2015 Year 10 Month 30 Day

Date trial data considered complete

2015 Year 10 Month 30 Day

Date analysis concluded

2015 Year 12 Month 30 Day


Other

Other related information



Management information

Registered date

2015 Year 09 Month 15 Day

Last modified on

2016 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022002


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name