UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of home-based neuromuscular electrical stimulation for patients with arteriosclerosis obliterans -Randomized Controlled Trial-
Title of the study (Brief title)	Effects of home-based neuromuscular electrical stimulation for patients with arteriosclerosis obliterans -Randomized Controlled Trial-
Region	Japan

Condition
Condition	arteriosclerosis obliterans
Classification by specialty	Medicine in general Cardiology Vascular surgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate effects of home-based neuromuscular electrical stimulation for patients with arteriosclerosis obliterans
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of intermittent claudication (treadmill exercise test, six-minute walk distance)
Key secondary outcomes	1. QOL 2. Ankle brachial index 3. Vascular endothelial function 4. Transcutaneous oxygen pressure 5. Autonomic nervous activity 6. Motor functions (muscle strength, balance function, walking speed) 7. Laboratory data (coronary risk factors, oxidative stress, and other biomarkers)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Behavior,custom
Interventions/Control_1	Supervised exercise therapy and home-based neuromuscular electrical stimulation
Interventions/Control_2	Supervised exercise therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with arteriosclerosis obliterans who have intermittent claudication
Key exclusion criteria	1. Patients with severe coronary artery stenosis 2. Patients with received hemodialysis 3. Patients with malignant disease in the past five years 4. Patients who used pacemaker 5. Patients who needed assistance for walking 6. Patients who are not allowed to receive neuromuscular electrical stimulation
Target sample size	60

Research contact person
Name of lead principal investigator	TANAKA SHINYA
Organization	Kitasato University
Division name	Graduate School of Medical Sciences
Address	1-15-1, kitasato, minami-ku, sagamiharashi, kanagawa
TEL	042-778-9081
Email	tanashin.pt@gmail.com

Public contact
Name of contact person	TANAKA SHINYA
Organization	Kitasato University
Division name	Graduate School of Medical Sciences
Address	1-15-1, kitasato, minami-ku, sagamiharashi, kanagawa
TEL	042-778-9081
Homepage URL
Email	tanashin.pt@gmail.com

Sponsor
Institute	Graduate School of Medical Sciences, Kitasato University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Japanese Physical Therapy Association
Organization
Division
Category of Funding Organization	Other
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	2014 Year 02 Month 09 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 09 Month 30 Day
Anticipated trial start date	2013 Year 10 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 02 Month 09 Day
Last modified on	2016 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015295