UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect verification of skeletal muscle electrical stimulation to the physical function and decreased activity in the perioperative of cardiovascular surgery
Title of the study (Brief title)	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	hiroki satou
Organization	kawasaki medical school hospital
Division name	rehabilitation center
Address	577,matushima,kurashiki-shi,okayama,japan
TEL	086-462-1111
Email	h0306@hp.kawasaki-m.ac.jp

Public contact
Name of contact person	hiroki satou
Organization	kawasaki medical school hospital
Division name	rehabilitation center
Address	577,matushima,kurashiki-shi,okayama,japan
TEL	086-462-1111
Homepage URL
Email	h0306@hp.kawasaki-m.ac.jp

Sponsor
Institute	kawasaki medical school
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028255