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Recruitment status Terminated
Unique ID issued by UMIN UMIN000036759
Receipt No. 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

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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
Email 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
Email y.kakimoto29@outlook.com

Sponsor
Institute Otemae Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041873

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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