UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024554 |
|---|---|
| Receipt number | R000028255 |
| Scientific Title | Effect verification of skeletal muscle electrical stimulation to the physical function and decreased activity in the perioperative of cardiovascular surgery |
| Date of disclosure of the study information | 2016/11/14 |
| Last modified on | 2019/01/11 06:20:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect verification of skeletal muscle electrical stimulation to the physical function and decreased activity in the perioperative of cardiovascular surgery
Acronym
Effect verification of skeletal muscle electrical stimulation to the physical function and decreased activity in the perioperative of cardiovascular surgery
Scientific Title
Effect verification of skeletal muscle electrical stimulation to the physical function and decreased activity in the perioperative of cardiovascular surgery
Scientific Title:Acronym
Effect verification of skeletal muscle electrical stimulation to the physical function and decreased activity in the perioperative of cardiovascular surgery
Region
| Japan |
Condition
Condition
cardiovascular surgery patients
Classification by specialty
| Cardiovascular surgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For muscle weakness perioperative targeting cardiac cardiovascular surgery patient, the usual physical therapy in combination skeletal muscle electrical stimulation was designed to verify the effects on skeletal muscle function and physical function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Knee extension strength,Evaluation period is pre-operative, post-operative day 14,1 month,3 months
Key secondary outcomes
muscle cross-sectional area and echogenicity of rectus femoris
six minutes walk test,Short Physical Performance Battery,MOS 36-Item Short-Form Health Survey
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention group, once a day until postoperative day 14, to implement the low-frequency electrical stimulation.
Interventions/Control_2
The control group is carried out only normal physical 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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Target surgery valve replacement, valvuloplasty, coronary artery bypass surgery, and thoracic aortic surgery.
Key exclusion criteria
Cases preoperatively have a mental disorder and severe cognitive impairment, disability, patients who have a sensory impairment in the lower limbs, a typical low-frequency treatment contraindications
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | hiroki satou |
Organization
kawasaki medical school hospital
Division name
rehabilitation center
Zip code
Address
577,matushima,kurashiki-shi,okayama,japan
TEL
086-462-1111
h0306@hp.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | hiroki satou |
Organization
kawasaki medical school hospital
Division name
rehabilitation center
Zip code
Address
577,matushima,kurashiki-shi,okayama,japan
TEL
086-462-1111
Homepage URL
h0306@hp.kawasaki-m.ac.jp
Sponsor or person
Institute
kawasaki medical school
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 11 | Month | 14 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 14 | 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
| 2016 | Year | 10 | Month | 25 | Day |
Last modified on
| 2019 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028255
