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Trial registered on ANZCTR


Registration number
ACTRN12614001059651
Ethics application status
Approved
Date submitted
22/02/2014
Date registered
3/10/2014
Date last updated
13/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of combined electrical muscle stimulation and resistance exercises on duration of mechanical ventilation in critically ill patients: a randomized controlled trial
Scientific title
Effects of combined electrical muscle stimulation and resistance exercises in duration of mechanical ventilation in critically ill patients
Secondary ID [1] 284117 0
nil
Universal Trial Number (UTN)
U1111-1153-3132
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mechanical ventilation 291193 0
muscle dysfunction 291194 0
critical illness 291232 0
Condition category
Condition code
Musculoskeletal 291529 291529 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 291530 291530 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients eligible were randomized to a 55 minutes session of resistance exercise (RE), electrical muscle stimulation (EMS), combined exercise (EMS + RE) or usual care (control group, CG). We used sequentially numbered, opaque, sealed envelopes to maintain randomization allocation.
RE group started with passive mobilization; as patient was regaining consciousness, resistance was applied through active exercises (biceps, triceps and lower extremities) and resistance exercises with elastic band (Theraband, Mercury, Brazil). EMS group received daily EMS sessions of both lower extremities. EMS was implemented simultaneously on the vastus lateralis and vastus medialis. After shaving and skin cleaning, rectangular electrodes (90 x 50 mm) were placed on the motor points of vastus lateralis and vastus medialis of both legs. The stimulator (Industrial Electronic Technology Ltda, Brazil) delivered biphasic, symmetric impulses of 45 Hz, 400 micro seconds pulse duration, 12 seconds on (including 0,8 second rise time and 0,8 second fall time) and 6 seconds off, at intensities able to cause visible contractions. In case of doubt, contraction was confirmed by palpation of the muscles involved. The duration of the session was 55 minutes including 5 minutes for warm up and 5 minutes for recovery. Combined exercise group used both techniques, RE plus EMS at the same time. All patients received respiratory physiotherapy (positioning, mucus clearance techniques) during 30 minutes, twice a day, seven days per week . Interventions were continued until ICU discharge. RE will be applied once daily until ICU discharge.
Intervention code [1] 288841 0
Rehabilitation
Comparator / control treatment
Usual care group was characterized as a control group, with no exercise interventions, only respiratory physiotherapy.
Control group
Active

Outcomes
Primary outcome [1] 291528 0
duration of mechanical ventilation (discontinuation of mechanical ventilation support with no need of return for mechanical ventilation until intensive care unit discharge)
Timepoint [1] 291528 0
at discharge from intensive care unit
Secondary outcome [1] 306977 0
length of stay in intensive care unit
Timepoint [1] 306977 0
the moment when the patient was discharged from intensive care unit
Secondary outcome [2] 310678 0
Biomarker analysis
Timepoint [2] 310678 0
Participants who consent to participation will also be
approached for consent to biomarker assessment involving
blood samples. Venous blood (15 ml) will be collected at each time point and processed to obtain plasma and serum for
subsequent analyses. Stored plasma and serum will be
analysed using ELISA methods for IGF-1, IL-1 beta, IL-6,
IL-10, IL-18 and TNF-alpha. Biomarker assessment will be performed at baseline, and at ICU discharge (where possible
the ‘ICU discharge’ measure will occur 24 h post final
intervention exercise session).

Eligibility
Key inclusion criteria
All patients consecutively admitted to the multidisciplinary ICU of San Jose Hospital during the study period were considered for inclusion in the study. All patients who had been on mechanical ventilation for less than 72 hours, and were expected to continue for at least 24 hours, were included.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
preexisting neuromuscular disease (e.g. Myasthenia Gravis, Guillain-Barre disease), cardiopulmonary arrest, end-stage malignancy, raised intracranial pressure, or technical obstacles that did not allow the implementation of EMS such as bone fractures or skin lesions

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We used sequentially numbered, opaque, sealed envelopes to maintain randomization allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All patients eligible were randomized to a 55 minutes session of resistance exercise (RE), electrical muscle stimulation (EMS), combined exercise (EMS + RE) or usual care (control group, CG). We used simple randomisation using a randomisation table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data were analyzed by an intention to treat approach. Patients who died during the study received scores of 0 for all endpoints. We used the chi-squared test or Fisher Exact test (as appropriate) to compare categorical variables between the four study groups, including the endpoint, and the Wilcoxon-Mann-Whitney two-sample rank-sum test or t tests to compare continuous variables. The differences between groups were analyzed by the one-factor mixed model ANOVA, corrected by change (post – pre) fasting blood glucose and Glasgow score. All significant main effects and interactions were subsequently analyzed using Bonferroni honestly significant difference post hoc test. To compare the effect of the treatment protocol on the duration of mechanical ventilation and changes blood glucose, we used linear regression analysis. Statistical significance was established as P<0.05. For biomarker analyses the sample size calculation is based on prior trials detecting changes in muscle protein synthesis and associated signalling following exercise, (increase in signalling >20% with SD in signalling of 2%).Using a=0.05 and power=0.80 the required sample size is 18 cases. To account for dropouts and mortality we have increased this sample size to 40 cases.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2014
Actual
1/08/2014
Date of last participant enrolment
Anticipated
31/12/2014
Actual
24/09/2015
Date of last data collection
Anticipated
Actual
15/10/2015
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 5846 0
Brazil
State/province [1] 5846 0
Distrito Federal

Funding & Sponsors
Funding source category [1] 288746 0
University
Name [1] 288746 0
University of Brasilia Brazil
Country [1] 288746 0
Brazil
Primary sponsor type
University
Name
University of Brasilia Brazil
Address
Centro Metropolitano
Conjunto A
Lote 01
Ceilandia
Brasilia - DF
ZIP: 72220-900
Country
Brazil
Secondary sponsor category [1] 287441 0
None
Name [1] 287441 0
Address [1] 287441 0
Country [1] 287441 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290616 0
University of Brasilia Brazil
Ethics committee address [1] 290616 0
Centro Metropolitano Conjunto A Lote 01 Ceilandia
Brasilia - DF ZIP: 72220-900
Ethics committee country [1] 290616 0
Brazil
Date submitted for ethics approval [1] 290616 0
15/12/2009
Approval date [1] 290616 0
15/02/2010
Ethics approval number [1] 290616 0

Summary
Brief summary
Millions of patients are admitted to an intensive care unit (ICU) worldwide each year. Due to medical advances, more patients are surviving critical illness. Critical care survival comes at important costs to patient in terms of impaired physical function and quality of life and to society in terms of ongoing health care utilization and lost productivity, especially those who received prolonged mechanical ventilation.
Critical illness polyneuromyopathy (CIPNM) is an acquired neuromuscular disorder observed in survivors of acute critical illness. This syndrome delays weaning from mechanical ventilation, increases the length of stay at the ICU, compromises rehabilitation and may result in a lifelong loss of function and in a reduction in quality of life.
Emerging evidence is demonstrating that early rehabilitation may benefit ICU patients. Early mobilization is feasible and well tolerated, decreases both ICU and hospital length of stay and improves functional outcomes at hospital discharge. However, not all patients in the ICU can participate in physical activity because of sedation, impaired cognition, or insufficient physiological reserve.
Electrical muscle stimulation (EMS) has been used as an alternative for disabled patients in chronic heart failure and chronic obstructive lung disease. Recent studies have showed that EMS may be well tolerated in ICU patients, preserving muscle mass and improving clinical outcomes.
To our knowledge, there are no previous studies comparing the effect of combined EMS plus resistance exercise (RE) in ICU patients. We hypothesized that EMS plus RE, as an alternative form of exercise, could improve clinical outcomes of critically ill patients receiving mechanical ventilation. The scope of the present study is to assess the effect of EMS, RE, and EMS plus RE on the duration of mechanical ventilation in critically ill patients hospitalized in a multidisciplinary ICU.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46278 0
Dr Luciana Vieira
Address 46278 0
Condominio Estancia Quintas da Alvorada quadra 2 conjunto 13 casa 17
Lago Sul
Brasilia
Distrito Federal
ZIP 71680389
Country 46278 0
Brazil
Phone 46278 0
+556181511027
Fax 46278 0
Email 46278 0
[email protected]
Contact person for public queries
Name 46279 0
Gerson Cirpiano Jr
Address 46279 0
Centro Metropolitano Conjunto A Lote 01
Ceilandia
ZIP 72220-900
Country 46279 0
Brazil
Phone 46279 0
+ 55 61 81907111
Fax 46279 0
Email 46279 0
[email protected]
Contact person for scientific queries
Name 46280 0
Vinicius Maldaner
Address 46280 0
Centro Metropolitano Conjunto A Lote 01
Ceilandia
ZIP 72220-900
Country 46280 0
Brazil
Phone 46280 0
+ 55 61 96522517
Fax 46280 0
Email 46280 0
[email protected]

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