UMIN-CTR Clinical Trial

Basic information
Public title	Effects of neuromuscular electrical stimulation on bone mineral density in patients undergoing hemodialysis: a randomized controlled trial
Acronym	Neuromuscular electrical stimulation in patients undergoing hemodialysis
Scientific Title	Effects of neuromuscular electrical stimulation on bone mineral density in patients undergoing hemodialysis: a randomized controlled trial
Scientific Title:Acronym	Neuromuscular electrical stimulation in patients undergoing hemodialysis
Region	Japan

Condition
Condition	Patients undergoing hemodialysis
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of neuromuscular electrical stimulation on bone mineral density in patients undergoing hemodialysis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bone strength
Key secondary outcomes

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	The treatment group will be received neuromuscular electrical stimulation in the lower extremities for 6-month, 3 times/week (30 min) during hemodialysis sessions.
Interventions/Control_2	The control group will be received usual care.
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients undergoing hemodialysis therapy for at least 3-month 2. Patients aged 50 years and older 3. Patients who agree in writing to participate in the study
Key exclusion criteria	1. Patients who underwent leg amputation 2. Patients with a pacemaker or ICD 3. Patients with severe sensory impairments 4. Patients with hemiplegia 5. Patients with untreated bleeding 6. Patients with unstable angina pectoris 7. Patients with an uncontrolled arrhythmia 8. Patients who suffering from hemodynamic instability 9. Patients who started drug therapy for osteoporosis within 1-year prior to participation of the present study 10. Patients who are identified as inadequacy participating into the study for a reason other than above 1.-9. by physician and/or study investigators.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Ryota Middle name Last name Matsuzawa
Organization	Hyogo Medical University
Division name	Department of Physical Therapy School of Rehabilitation
Zip code	650-8530
Address	1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo
TEL	078-304-3181
Email	ri-matsuzawa@hyo-med.ac.jp

Public contact
Name of contact person	1st name Ryota Middle name Last name Matsuzawa
Organization	Hyogo Medical University
Division name	Department of Physical Therapy School of Rehabilitation
Zip code	650-8530
Address	1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo
TEL	078-304-3181
Homepage URL
Email	ri-matsuzawa@hyo-med.ac.jp

Sponsor
Institute	Department of Physical Therapy School of Rehabilitation, Hyogo Medical University, Kobe, Hyogo, Japan
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science, the Grant-in-Aid for Young Scientists
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Ethics Review Board of Hyogo Medical University
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501
Tel	0798-45-6066
Email	rinri@hyo-med.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	2022 Year 07 Month 31 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	Preinitiation
Date of protocol fixation	2022 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date	2022 Year 10 Month 01 Day
Last follow-up date	2024 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 07 Month 14 Day
Last modified on	2022 Year 07 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055138