UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031938
Receipt number R000036084
Scientific Title Examination of factors constituting fatigue of patients with maintenance dialysis patients and verification of effects of aerobic exercise to improve fatigue
Date of disclosure of the study information 2018/03/29
Last modified on 2020/10/19 19:51:08

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Basic information

Public title

Examination of factors constituting fatigue of patients with maintenance
dialysis patients and verification of effects of aerobic exercise to improve
fatigue

Acronym

study on fatigue in patients with maintenance dialysis

Scientific Title

Examination of factors constituting fatigue of patients with maintenance
dialysis patients and verification of effects of aerobic exercise to improve
fatigue

Scientific Title:Acronym

study on fatigue in patients with maintenance dialysis

Region

Japan


Condition

Condition

maintenance dialysis patients

Classification by specialty

Nephrology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

exercise establishes as one of the evidence approaches to fatigue of dialysis patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

fatigability

Key secondary outcomes

Physical activity, Lower limb muscle, Fatigue, Depression


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

aerobic exercise during hemodialysis for two months

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Able to ambulate
2) Capable of giving informed consent

Key exclusion criteria

1) Hospitalization within 3 months prior to study enrollment
2)Duration of maintenance hemodialysis less
than 3 months
3)Evidence of active malignancy
4)Those who are told refrain from exercising
5)Leg amputation
6)Those who have difficulty understanding instruction

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Nishida
Middle name
Last name yuusuke

Organization

International University of Health and Welfare

Division name

Health Science at Narita Department of Physical Therapy

Zip code

286-8686

Address

4-3 Kozunomori, Narita city, Chiba 286-8686 Japan

TEL

0476-20-7701

Email

yuusuken@iuhw.ac.jp


Public contact

Name of contact person

1st name Takeki
Middle name
Last name Ishida

Organization

Graduate School of International University of Health and Welfare

Division name

Department of Health and Science, Health and Welfare Science Course

Zip code

286-8686

Address

4-3 Kozunomori, Narita city, Chiba 286-8686 Japan

TEL

0476-20-7701

Homepage URL


Email

17S3008@g.iuhw.ac.jp


Sponsor or person

Institute

Graduate School of International University of Health and Welfare

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

Graduate School of International University of Health and Welfare

Address

4-3 Kozunomori, Narita city, Chiba 286-8686 Japan

Tel

0476-20-7701

Email

s-rinri@iuhw.ac.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

2018 Year 03 Month 29 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

Enrolling by invitation

Date of protocol fixation

2018 Year 03 Month 01 Day

Date of IRB

2018 Year 07 Month 27 Day

Anticipated trial start date

2019 Year 12 Month 01 Day

Last follow-up date

2021 Year 03 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

2018 Year 03 Month 28 Day

Last modified on

2020 Year 10 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036084


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name