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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018542
Receipt No. R000015958
Scientific Title Effects of perioperative electrical muscle stimulation on muscle proteolysis in patients after cardiovascular surgery. -single facility preliminary study-
Date of disclosure of the study information 2015/08/04
Last modified on 2020/02/06

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Basic information
Public title Effects of perioperative electrical muscle stimulation on muscle proteolysis in patients after cardiovascular surgery.
-single facility preliminary study-
Acronym Effects of perioperative electrical muscle stimulation on muscle proteolysis in patients after cardiovascular surgery.
-single facility preliminary study-
Scientific Title Effects of perioperative electrical muscle stimulation on muscle proteolysis in patients after cardiovascular surgery.
-single facility preliminary study-
Scientific Title:Acronym Effects of perioperative electrical muscle stimulation on muscle proteolysis in patients after cardiovascular surgery.
-single facility preliminary study-
Region
Japan

Condition
Condition Adult patients who are intending for elective cardiovascular surgery
Classification by specialty
Cardiovascular surgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of perioperative electrical muscle stimulation on muscle proteolysis after cardiovascular surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 3 - methylhistidine

Key secondary outcomes IL6
Isometric Knee extensor muscle strength
Grip strength
Respiratory muscle strength
10m normal walking time
Mid arm, thigh and calf cirecumference
Self-efficacy of physical activity
Hospital Anxiety and Depression scale
Performance Measure for Activities of Daily Living -8
Participation-6
Nutritional questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Pre- and post- operative electrical muscle stimulation and ambulation program.
Electrical muscle stimulation: implemented on the bilateral quadriceps and triceps surae muscle for 30-60 minutes per day. More than 3 times before surgery, 5 times after surgery.
Interventions/Control_2 Ambulation program
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Over 20 years-old
2. Patients who are intended for elective cardiovascular surgery.
Key exclusion criteria 1. Patients with hemodialysis.
2. Patients with chronic renal failure (GFR<30)
3. Patients who are not allowed to receive electrical muscle stimulation by primary doctor.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Kitamura
Organization Nagoya Heart Center
Division name Cardiovascular Surgery
Zip code 461-0045
Address Sunadabashi 1-1-14, Higashi-ku, Nagoya, Aichi
TEL 052-719-0810
Email kitamura@heart-center.or.jp

Public contact
Name of contact person
1st name Hideki
Middle name
Last name Kitamura
Organization Nagoya Heart Center
Division name Cardiovascular Surgery
Zip code 461-0045
Address Sunadabashi 1-1-14, Higashi-ku, Nagoya, Aichi
TEL 052-719-0810
Homepage URL
Email kitamura@heart-center.or.jp

Sponsor
Institute Nagoya Heart Center
Institute
Department

Funding Source
Organization Suzuken Memorial Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya Heart Center
Address 1-1-14 Sunadabashi, Higashiku, Nagoya 461-0045, Japan
Tel 052-719-0810
Email kitamura@heart-center.or.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
2015 Year 08 Month 04 Day

Related information
URL releasing protocol https://www.semthorcardiovascsurg.com/article/S1043-0679(18)30322-8/fulltext
Publication of results Published

Result
URL related to results and publications https://www.semthorcardiovascsurg.com/article/S1043-0679(18)30322-8/fulltext
Number of participants that the trial has enrolled 119
Results
Of 498 consecutive patients screened for eligibility, 119 participants (intervention group, n=60; control group, n=59) were enrolled. In the overall subjects, there were no differences in any outcomes between the intervention and control groups. 
Results date posted
2020 Year 02 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
After cardiovascular surgery, muscle wasting is induced by systemic inflammation.1 This acute inflammatory response accelerates protein catabolism and decreases protein synthesis, resulting in increased muscle proteolysis.2, 3 In addition, perioperative immobilization or physical inactivity also promotes muscle wasting.4 Since this postoperative muscle wasting results in muscle weakness and functional decline, postoperative rehabilitation mainly aims to prevent muscle loss and weakness as well as postoperative complications. To avoid this, early mobilization has been introduced, but muscle proteolysis markedly accelerates within 48 hours after cardiovascular surgery,5 and it is often difficult for postoperative patients to initiate sufficient muscle activities due to hemodynamic instability. Supplemental interventions to prevent muscle wasting immediately after surgery thus need to be developed.
Neuromuscular electrical stimulation (NMES) is an intervention modality that can induce sufficient muscle contraction without the patient's volitional efforts. Iwatsu et al previously reported that NMES could be safely applied to patients even immediately after cardiovascular surgery.6 In addition, a subsequent trial demonstrated favorable effects of NMES on skeletal muscle proteolysis and muscle weakness.7 However, a cause-effect relationship has yet to be established because of the lack of randomization and blinded assessment of muscle strength.
Participant flow
The present study was conducted as a single-center, randomized study. Consecutive patients who underwent cardiovascular surgery at Nagoya Heart Center from May 2014 to September 2016 were approached. Exclusion criteria for this study included (1) emergency cases; (2) renal dysfunction, defined as estimated glomerular filtrating rate <30 ml/min/1.73 m2 before surgery; (3) chronic hemodialysis before surgery or patients who require new hemodialysis after surgery; (4) neurologic dysfunction before or after surgery including postoperative delirium; or (5) disagreement with participation in the study.
Adverse events
arrhythmia, leg pain
Outcome measures
Primary outcomes in this study were the mean concentration of 3-methylhistidine concentration corrected for urinary creatinine (Cre) content (3-MH/Cre) from POD1 to POD6, and KEIS on POD7.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 04 Month 07 Day
Date of IRB
2014 Year 02 Month 18 Day
Anticipated trial start date
2014 Year 04 Month 25 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 04 Day
Last modified on
2020 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015958

Research Plan
Registered date File name
2020/02/06 研究計画概要書 北村用.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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