UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052000 |
|---|---|
| Receipt number | R000059355 |
| Scientific Title | Elucidation of the Mechanism of Preconditioning Effects of Neuromuscular Electrical Stimulation on Patients with Peripheral Arterial Disease and Search for Optimal Intensity |
| Date of disclosure of the study information | 2023/09/15 |
| Last modified on | 2024/08/30 01:13:30 |
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Basic information
Public title
Elucidation of the Mechanism of Preconditioning Effects of Neuromuscular Electrical Stimulation on Patients with Peripheral Arterial Disease and Search for Optimal Intensity
Acronym
Elucidation of the Mechanism of Preconditioning Effects of Neuromuscular Electrical Stimulation on Patients with Peripheral Arterial Disease and Search for Optimal Intensity
Scientific Title
Elucidation of the Mechanism of Preconditioning Effects of Neuromuscular Electrical Stimulation on Patients with Peripheral Arterial Disease and Search for Optimal Intensity
Scientific Title:Acronym
Elucidation of the Mechanism of Preconditioning Effects of Neuromuscular Electrical Stimulation on Patients with Peripheral Arterial Disease and Search for Optimal Intensity
Region
| Japan |
Condition
Condition
peripheral arterial disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the mechanism of claudication distance prolongation after electrical stimulation of skeletal muscles and to search for the most effective pre-conditioning method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intermittent claudication distance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
SHAM
Interventions/Control_2
NMES 20Hz high strength
Interventions/Control_3
NMES 20Hz medium strength
Interventions/Control_4
NMES 4Hz high strength
Interventions/Control_5
NMES 4Hz medium strength
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
PAD Fontaine classification II degree
Key exclusion criteria
Patients with intermittent claudication for reasons other than peripheral arterial disease.
Patients with unstable angina or acute myocardial infarction .
Patients with ischemia of the lower extremities who have ulcers and pain at rest.
Patients with pacemakers or other devices inserted.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Yasu |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Cardiology, Vascular and Nephrology
Zip code
3211298
Address
145-1 Moritomo, Nikko-shi, Tochigi
TEL
0288237000
tyasu@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Kyosuke |
| Middle name | |
| Last name | Ehara |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Rehabilitation Department
Zip code
3211298
Address
145-1 Moritomo, Nikko-shi, Tochigi
TEL
0288237000
Homepage URL
the.kyo.pt0430@gmail.com
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Ehara kyosuke
Funding Source
Organization
not
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
Dokkyo Medical University Nikko Medical Center
Address
145-1 Moritomo, Nikko-shi, Tochigi
Tel
0288237000
the.kyo.pt0430@gmail.com
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
| 2023 | Year | 09 | Month | 15 | 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
15
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2023 | Year | 08 | Month | 24 | Day |
Last modified on
| 2024 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059355
