Effects of Neuromuscular Electrical Stimulation on Muscle Mass and Strength in Critically Ill Patients After Cardiothoracic Surgery (Catastim 2)

July 6, 2015 updated by: Arabella Fischer, MD, Medical University of Vienna

Effects of Neuromuscular Electrical Stimulation on Muscle Mass and Strength in Critically Ill Patients After Cardiothoracic Surgery. An Ultrasound-Based Randomized Controlled Trial

The purposes of this study are 1) to determine whether neuromuscular electrical stimulation (NMES) is effective in preventing loss of muscle mass and strength and 2) to observe the time variation of MLT and strength from preoperative day to hospital discharge.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the amendment of June 2011, a twofold study setting was defined in order to recruit patients not only before, but also after cardiothoracic surgery. In sample A, patients were recruited before surgery. In sample B, patients were recruited after surgery. On postoperative day 1, randomization was performed for sample A and B separately. To ensure balance of the NMES and control groups with respect to disease severity, randomization was stratified by the SAPS II score on the first postoperative day. In the intervention group, the anterior muscles of both thighs were electrically stimulated from the first postoperative day until ICU discharge for a maximum of 14 days. In the control group, the electrodes were applied, but no electricity was delivered.The primary outcomes muscle layer thickness (MLT) and muscle strength were assessed from the first postoperative day to ICU discharge and at hospital discharge. All patients in sample A had an additional assessment of MLT and strength before surgery.

All data are analyzed according to the intention-to-treat principle with no imputation for any missing data. Linear mixed models are used to account for the repeated measurements per patient and to determine any fixed effects on MLT and MRC score.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients before/after cardiothoracic surgery
  • ICU stay > 48 hours

Exclusion Criteria:

  • body mass index > 40 kg/m2
  • severe leg swelling
  • implanted ventricular assist device (RVAD, LVAD, BiVAD)
  • implanted intra-aortic balloon pump (IABP)
  • neuromuscular diseases
  • skin lesions in stimulation area
  • leg excluded if implant (hip or knee replacement) in stimulation area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NMES group
Anterior muscles of both thighs were electrically stimulated twice a day (2×30 minutes of NMES with a break of at least 30 minutes between both sessions) 7 days a week during the entire ICU stay but no longer than 14 days, starting on postoperative day 1. Highest tolerable intensity was applied.
Device: Compex 3 Professional (CefarCompex Medical AB) stimulator
NMES
Sham Comparator: Control group
In the control group, the electrodes were applied, connected to the stimulator, but no electricity was delivered.
Device: sham-stimulation
no electricity applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle layer thickness (MLT)
Time Frame: on preoperative day, from postoperative day 1 onwards every other ICU day for the duration of the ICU stay (expected average of ICU stay: 7 days) and at day of hospital discharge (expected average of hospital stay: 20 days)
Muscle layer thickness of the anterior muscles of the thigh using two-dimensional B-mode ultrasound
on preoperative day, from postoperative day 1 onwards every other ICU day for the duration of the ICU stay (expected average of ICU stay: 7 days) and at day of hospital discharge (expected average of hospital stay: 20 days)
Muscle strength
Time Frame: on preoperative day, from postoperative day 1 onwards every day for the duration of the ICU stay (expected average of ICU stay: 7 days), at day of hospital discharge (expected average of hospital stay: 20 days)
Muscle strength using Medical Research Council (MRC) score and hand dynamometry
on preoperative day, from postoperative day 1 onwards every day for the duration of the ICU stay (expected average of ICU stay: 7 days), at day of hospital discharge (expected average of hospital stay: 20 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
JAGS score
Time Frame: on preoperative day, on day of ICU discharge (expected average of ICU stay: 7 days), on day of hospital discharge (expected average of hospital stay: 20 days)
JAGS score
on preoperative day, on day of ICU discharge (expected average of ICU stay: 7 days), on day of hospital discharge (expected average of hospital stay: 20 days)
Timed Up and Go test
Time Frame: on preoperative day, on day of hospital discharge (expected average of hospital stay: 20 days)
Timed Get Up and Go test
on preoperative day, on day of hospital discharge (expected average of hospital stay: 20 days)
FIM score
Time Frame: on preoperative day, on day of hospital discharge (expected average of hospital stay: 20 days)
Functional Independance Measure (FIM) score
on preoperative day, on day of hospital discharge (expected average of hospital stay: 20 days)
SF-12 score
Time Frame: on preoperative day, on day of hospital discharge (expected average of hospital stay: 20 days)
12-item Short Form Health Survey (SF-12)
on preoperative day, on day of hospital discharge (expected average of hospital stay: 20 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Study Director: Michael Hiesmayr, MD, Prof., Medical University of Vienna
  • Principal Investigator: Arabella Fischer, MD, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 7, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 18, 2015

Study Record Updates

Last Update Posted (Estimate)

July 8, 2015

Last Update Submitted That Met QC Criteria

July 6, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1072/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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