UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036759 |
|---|---|
| Receipt number | R000041873 |
| Scientific Title | Effects of neuromuscular electrical stimulation on quadriceps muscle strength -Trial for cardiovascular surgery patients- |
| Date of disclosure of the study information | 2019/05/15 |
| Last modified on | 2019/09/12 11:45:05 |
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Basic information
Public title
Effects of neuromuscular electrical stimulation on quadriceps muscle strength
-Trial for cardiovascular surgery patients-
Acronym
Effects of neuromuscular electrical stimulation on quadriceps muscle strength
-Trial for cardiovascular surgery patients-
Scientific Title
Effects of neuromuscular electrical stimulation on quadriceps muscle strength
-Trial for cardiovascular surgery patients-
Scientific Title:Acronym
Effects of neuromuscular electrical stimulation on quadriceps muscle strength
-Trial for cardiovascular surgery patients-
Region
| Japan |
Condition
Condition
Angina, valvular disease
Classification by specialty
| Cardiovascular surgery | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of neuromuscular electrical stimulation on quadriceps femoris muscle strength at discharge are clarified clinically for cases after cardiovascular surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee extension strength
Key secondary outcomes
Grip strength
Quadriceps muscle thickness
Short Physical Performance Battery
6 minute walk test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
Interventions/Control_1
Electromyoelectric stimulation is performed 5 times a week for 30 minutes a day from the first postoperative day to discharge from the hospital.
Interventions/Control_2
Carry out rehabilitation after cardiovascular surgery.
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Person planning coronary artery bypass graft surgery (CABG) or valvular surgery
70 years old or older
Key exclusion criteria
Person who has ever experienced neuromuscular electrical stimulation
Person performing dialysis
Person who is operating implanted electrodes such as pacemakers
Person presenting sense loss in upper and lower limbs
Patients who have open wounds or skin allergic symptoms at the treatment site
Persons who explained the purpose of this research and did not obtain written consent from the patient or the representative
Person who the investigative doctor or research director judged as inappropriate as a subject
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | yuki |
| Middle name | |
| Last name | kakimoto |
Organization
Otemae Hospital
Division name
Division of physical medicine and rehabilitation
Zip code
540-0008
Address
1-5-34 Otemae, Chuo-ku, Osaka City, Osaka Prefecture
TEL
06-6941-0484
y.kakimoto29@outlook.com
Public contact
Name of contact person
| 1st name | yuki |
| Middle name | |
| Last name | kakimoto |
Organization
Otemae Hospital
Division name
Clinical Research Center Clinical Trials Office
Zip code
540-0008
Address
1-5-34 Otemae, Chuo-ku, Osaka City, Osaka Prefecture
TEL
06-6941-0484
Homepage URL
y.kakimoto29@outlook.com
Sponsor or person
Institute
Otemae Hospital
Institute
Department
Personal name
Funding Source
Organization
Kio University
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
Otemae Hospital Clinical Research Center Clinical Trials Office
Address
1-5-34 Otemae, Chuo-ku, Osaka City, Osaka Prefecture
Tel
06-6941-0484
info@otemae.gr.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
| 2019 | Year | 05 | 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
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
| 2018 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 06 | 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
| 2019 | Year | 05 | Month | 15 | Day |
Last modified on
| 2019 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041873
