UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of electrical muscle stimulation on physical performance, quality of life, and hormone level in patients with chronic kidney disease
Title of the study (Brief title)	Effect of electrical muscle stimulation in patients with chronic kidney disease
Region	Japan

Condition
Condition	Chronic kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assessment of the effect of electrical muscle stimulation in patients with chronic kidney disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Lower-limb muscle strength
Key secondary outcomes	Muscle cross-sectional area Balance ability Quality of life Blood exam

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Electrical muscle stimulation for 8 weeks
Interventions/Control_2	Electrical muscle stimulation (-)
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Stage 5 CKD(chronic kidney disease)
Key exclusion criteria	Metallic insertion Severe heart disease Dementia
Target sample size	40

Research contact person
Name of lead principal investigator	Tadashi Suzuki
Organization	The Jikei University School of Medicine
Division name	Department of Rehabilitation Medicine
Address	3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Email	rehadoc441124@jikei.ac.jp

Public contact
Name of contact person	Tadashi Suzuki
Organization	The Jikei University School of Medicine
Division name	Department of Rehabilitation Medicine
Address	3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Homepage URL
Email	rehadoc441124@jikei.ac.jp

Sponsor
Institute	The Jikei University
Institute
Department

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)

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	2013 Year 10 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 12 Day
Anticipated trial start date	2013 Year 10 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/?term=Beneficial+effect+of+intradialytic+electrical+muscle+stimu
Results
Other related information

Management information
Registered date	2013 Year 10 Month 17 Day
Last modified on	2018 Year 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014101