Unique ID issued by UMIN | UMIN000018542 |
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Receipt number | 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 20:17:47 |
Effects of perioperative electrical muscle stimulation on muscle proteolysis in patients after cardiovascular surgery.
-single facility preliminary study-
Effects of perioperative electrical muscle stimulation on muscle proteolysis in patients after cardiovascular surgery.
-single facility preliminary study-
Effects of perioperative electrical muscle stimulation on muscle proteolysis in patients after cardiovascular surgery.
-single facility preliminary study-
Effects of perioperative electrical muscle stimulation on muscle proteolysis in patients after cardiovascular surgery.
-single facility preliminary study-
Japan |
Adult patients who are intending for elective cardiovascular surgery
Cardiovascular surgery | Rehabilitation medicine |
Others
NO
To investigate the effect of perioperative electrical muscle stimulation on muscle proteolysis after cardiovascular surgery.
Efficacy
Not applicable
3 - methylhistidine
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
YES
Central registration
2
Treatment
Device,equipment |
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.
Ambulation program
20 | years-old | <= |
Not applicable |
Male and Female
1. Over 20 years-old
2. Patients who are intended for elective cardiovascular surgery.
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.
120
1st name | Hideki |
Middle name | |
Last name | Kitamura |
Nagoya Heart Center
Cardiovascular Surgery
461-0045
Sunadabashi 1-1-14, Higashi-ku, Nagoya, Aichi
052-719-0810
kitamura@heart-center.or.jp
1st name | Hideki |
Middle name | |
Last name | Kitamura |
Nagoya Heart Center
Cardiovascular Surgery
461-0045
Sunadabashi 1-1-14, Higashi-ku, Nagoya, Aichi
052-719-0810
kitamura@heart-center.or.jp
Nagoya Heart Center
Suzuken Memorial Foundation
Non profit foundation
Nagoya Heart Center
1-1-14 Sunadabashi, Higashiku, Nagoya 461-0045, Japan
052-719-0810
kitamura@heart-center.or.jp
NO
2015 | Year | 08 | Month | 04 | Day |
https://www.semthorcardiovascsurg.com/article/S1043-0679(18)30322-8/fulltext
Published
https://www.semthorcardiovascsurg.com/article/S1043-0679(18)30322-8/fulltext
119
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.
2020 | Year | 02 | Month | 06 | Day |
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.
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.
arrhythmia, leg pain
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.
Completed
2014 | Year | 04 | Month | 07 | Day |
2014 | Year | 02 | Month | 18 | Day |
2014 | Year | 04 | Month | 25 | Day |
2017 | Year | 03 | Month | 31 | Day |
2015 | Year | 08 | Month | 04 | Day |
2020 | Year | 02 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015958
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2020/02/06 | 研究計画概要書 北村用.doc |
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