UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052299 |
|---|---|
| Receipt number | R000059700 |
| Scientific Title | The effectiveness of early neuromuscular electrical stimulation in patients after Stanford type A acute aortic dissection surgery |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2024/03/26 09:04:42 |
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Basic information
Public title
The effectiveness of early neuromuscular electrical stimulation in patients after acute aortic dissection surgery
Acronym
The effectiveness of early neuromuscular electrical stimulation in patients after acute aortic dissection surgery
Scientific Title
The effectiveness of early neuromuscular electrical stimulation in patients after Stanford type A acute aortic dissection surgery
Scientific Title:Acronym
The effectiveness of early neuromuscular electrical stimulation in patients after Stanford type A acute aortic dissection surgery
Region
| Japan |
Condition
Condition
Adult patient with Stanford type A acute aortic dissection undergoing emergency surgery
Classification by specialty
| Cardiovascular surgery | Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the use of neuromuscular electrical stimulation in addition to early mobilization and exercise in the early postoperative period preserves and improves muscle mass and strength.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change ratio of muscle thickness of rectus femoris, vastus intermedius, and quadriceps femoris at postoperative day 7 and 14.
Key secondary outcomes
Handgrip strength
Usual gait speed
Days until 100 m walking
Home discharge
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Postoperative mobilization and exercise program and neuromuscular electrical stimulation. Neuromuscular electrical stimulation: implemented on the bilateral quadriceps, hamstrings, triceps surae, tibial anterior muscles using belt electrode for 20 minutes per day from postoperative day 1 to 7.
Interventions/Control_2
Postoperative mobilization and exercise program and neuromuscular electrical stimulation. Neuromuscular electrical stimulation: implemented on the bilateral quadriceps muscle but intensity is not cause muscle contraction for 20 minutes per day from postoperative day 1 to 7.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Over 18 years old
2. Patients undergoing emergency surgery for Stanford type A acute aortic dissection
Key exclusion criteria
1. Patients after pacemaker implantation
2. Pregnant woman
3. Patients with skin disorder
4. Patients after stroke with severe functional limitation
5. Patients who cannot walk independently before surgery
6. Patients with deep vein thrombus
7. Patients with cognitive impairment
8. Patients with severe complications
9. Patients considered unsuitable by the physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Kiryu |
Organization
Akita University Graduate School of Medicine
Division name
Department of cardiovascular surgery
Zip code
010-8543
Address
44-2 Hasunuma Hiroomote, Akita City
TEL
0188841111
k.kiryu83@gmail.com
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Kiryu |
Organization
Akita University Graduate School of Medicine
Division name
Department of cardiovascular surgery
Zip code
010-8543
Address
44-2 Hasunuma Hiroomote, Akita City
TEL
0188841111
Homepage URL
k.kiryu83@gmail.com
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Institutional Review Board of the Akita University Graduate School of Medicine
Address
1-1-1 Hondo, Akita City
Tel
018-884-6028
soken@hos.akita-u.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
| 2023 | Year | 10 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | 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 | 09 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059700
