UMIN-CTR Clinical Trial

Basic information
Public title	Effects of renal rehabilitation exercise program in patients with end stage renal disease
Acronym	Effects of renal rehabilitation for end stage renal disease
Scientific Title	Effects of renal rehabilitation exercise program in patients with end stage renal disease
Scientific Title:Acronym	Effects of renal rehabilitation for end stage renal disease
Region	Japan

Condition
Condition	CKD stage5
Classification by specialty	Medicine in general Nephrology Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to evaluate and compare the effects of electrical stimulation for lower limbs on muscle strength, dialysis efficiency, and serum inflammatory markers, including cytokine factors.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	muscle power
Key secondary outcomes	dialysis efficiency, serum phosphorus, biochemical tests in cluding inflammatory markers

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver Other
Interventions/Control_1	Subjects underwent electrical stimulation for 1 hour or less during the first half of the HD session twice a week of 12 consecutive weeks.
Interventions/Control_2	They exercised for 1 hour or less during the first half of the HD session twice a week of 12 consecutive weeks on an ergometer load.
Interventions/Control_3	A group that underwent standard hemodialysis treatment without exercise programs
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	95 years-old >
Gender	Male and Female
Key inclusion criteria	The subjects were stable,maintenance hemodialysis patients who underwent outpatient hemodialysis treatment of three times a week
Key exclusion criteria	Acute coronary syndrome, particularly unstable angina and acute myocardial infarction; systolic blood pressure overed 180 mmHg or diastolic blood pressure overed 110 mmHg; and patients who were determined as inappropriate for the study by the attending physician.
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Middle name Last name Misa Miura
Organization	Tsukuba University of Technology
Division name	Faculty of Health Science
Zip code
Address	4-12-7,Kasuga,TsukubaCity,Ibaraki,Japan
TEL	029-858-9552
Email	m.miura@k.tsukuba-tech.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Misa Miura
Organization	Tsukuba University of Technology
Division name	Faculty of Health Science
Zip code
Address	4-12-7,Kasuga,TsukubaCity,Ibaraki,Japan
TEL	029-858-9552
Homepage URL
Email	m.miura@k.tsukuba-tech.ac.jp

Sponsor
Institute	Tsukuba University of Technology
Institute
Department

Funding Source
Organization	Tsukuba University of Technology
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Tohoku University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	2011-120-1
Org. issuing International ID_1	Tohoku University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	北柏リハビリテーション病院，平山病院

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 11 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	Completed
Date of protocol fixation	2011 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date	2014 Year 02 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 12 Month 31 Day
Date trial data considered complete	2016 Year 12 Month 31 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 04 Month 11 Day
Last modified on	2018 Year 04 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036726

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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