UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018542
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

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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 or person

Institute

Nagoya Heart Center

Institute

Department

Personal name



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

Value
https://center6.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