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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024554
Receipt No. 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

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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
Email 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
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028255

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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