UMIN-CTR Clinical Trial

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