UMIN-CTR Clinical Trial

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
Institute	Graduate School of International University of Health and Welfare
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036084