UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013110 |
|---|---|
| Receipt number | R000015295 |
| Scientific Title | Effects of home-based neuromuscular electrical stimulation for patients with arteriosclerosis obliterans -Randomized Controlled Trial- |
| Date of disclosure of the study information | 2014/02/09 |
| Last modified on | 2016/06/19 23:18:26 |
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Basic information
Public title
Effects of home-based neuromuscular electrical stimulation for patients with arteriosclerosis obliterans -Randomized Controlled Trial-
Acronym
Effects of home-based neuromuscular electrical stimulation for patients with arteriosclerosis obliterans -Randomized Controlled Trial-
Scientific Title
Effects of home-based neuromuscular electrical stimulation for patients with arteriosclerosis obliterans -Randomized Controlled Trial-
Scientific Title:Acronym
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)
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
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
| 1st name | |
| Middle name | |
| Last name | TANAKA SHINYA |
Organization
Kitasato University
Division name
Graduate School of Medical Sciences
Zip code
Address
1-15-1, kitasato, minami-ku, sagamiharashi, kanagawa
TEL
042-778-9081
tanashin.pt@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TANAKA SHINYA |
Organization
Kitasato University
Division name
Graduate School of Medical Sciences
Zip code
Address
1-15-1, kitasato, minami-ku, sagamiharashi, kanagawa
TEL
042-778-9081
Homepage URL
tanashin.pt@gmail.com
Sponsor or person
Institute
Graduate School of Medical Sciences, Kitasato University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Terminated
Date of protocol fixation
| 2013 | Year | 09 | Month | 30 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015295
