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Muscle WeaknessNCT04613908

Efficacy of Different Treatments for the Intensive Care Unit Acquired Weakness

A study testing neuro muscular electro stimulation and Early Mobilization protocol in people with Muscle Weakness and Rehabilitation, run by Hospital Nacional Profesor Alejandro Posadas.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Experimental study that has how to compare the efficacy between conventional rehabilitation, transcutaneous electrostimulation or early mobilization to reduce the time needed to reverse the muscle weakness evaluated by the muscle strength scale of the MRC in patients with a clinical diagnosis of intensive care unit… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Muscle Weakness, Rehabilitation
What is being tested?
neuro muscular electro stimulation and Early Mobilization protocol
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
No sites listed yet
Study dates
1 Aug 2015to 31 Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • subjects over 18 years of age,
  • admitted to the ICU who have received invasive mechanical ventilation for a period longer than 24 hours
  • clinical diagnosis of ICUAW (MRC-mss <48 measured over two consecutive days).

Who cannot join

  • subjects who presented a body mass index> 35 (kg/height x height)
  • presence of edema that prevents the realization of NMES at the time of diagnosis of ICUAW (assessed by the absence of visible contraction
  • pregnant women
  • subjects with pacemakers
  • subjects with injury of the central and / or peripheral nervous system (with motor sequelae)
  • previous neuromuscular disease
Show all 10Show fewer
  • limitation of the movement of any extremity due to orthopedic or traumatological causes
  • presence of a previous cognitive disorder that impedes the understanding of rehabilitation interventions
  • a value of the index of Barthel less than 35 points at admission
  • subjets who refused to give informed consent.

About this study

Official title: Efficacy of Conventional Rehabilitation, Transcutaneous Electro Nerve Stimulation or Early Mobilization to Reverse the Acquired Weakness of the Intensive Care Unit: Single Blind Controlled Clinical Trial

Experimental study that has how to compare the efficacy between conventional rehabilitation, transcutaneous electrostimulation or early mobilization to reduce the time needed to reverse the muscle weakness evaluated by the muscle strength scale of the MRC in patients with a clinical diagnosis of intensive care unit acquired weakness in the (ICUAW).The ambit of realization is a medical-surgical ICU of a general acute hospital (26 beds). A randomized controlled, uni-centric design was used. The interventions are divided into three groups namely; group 1 (control group) receiving standard or usual rehabilitation (GR-STD); group 2 receives transcutaneous electrostimulation (GR-TEE) and group 3 that consists of an early mobilization protocol (GR-EM). The main outcome variable of the study is the time, in days and sessions of treatment, to reverse the ICUAW.

Read the detailed description

Study hypothesis: the time to revert the intensive care unit acquired weakness is less when applying an early mobilization protocol or transcutaneous electro-nervous stimulation compared with the usual or standard rehabilitative treatment.

Ethical considerations: The research protocol was presented and approved by both the Ethics Committee and the Teaching and Research Committee of our institution. The informed consent of each subject included in the study was obtained.

Sample size and study power: a sample size was defined in 18 subjects (6 subjects per intervention group). The estimation of the sample was calculated for a one-way ANOVA where a minimum difference of 2 sessions was established between the treatments, assuming a standard deviation of 1.8 sessions, an alpha error of 5% and a power of 80%.

Statistical methods: the numerical variables will be presented as mean and standard deviation or median and interquartile range according to the presented distribution. The categorical variables will be presented by frequency and percentage.

For the comparison of continuous variables, Student's t test for independent samples or the Mann-Whitney U test will be used according to the presented distribution and for the categorical variables the Chi² test or the Fisher exact test will be used according to the conformation of the crossed table. The Shapiro-Wilk test will be used to evaluate whether the distribution presented by the numerical variables fits a normal distribution. Equality of variances was assessed by the Levene´s test.

The comparison of the time to reach an smuscle strength scale of the MRC ≥ 48 between the groups with different interventions will be used the one-way ANOVA test or the Kruskal-Wallis test as appropriate. For post hoc analysis, the pairs-comparison test of Games-Hollew or Dunn's-Bonferroni will be used for ANOVA or Kruskal-Wallis, respectively, when they reach statistical significance.

Being tested
neuro muscular electro stimulation, Early Mobilization protocol, standard care or usual rehabilitation
Keywords
Intensive Care Unit Acquired Weakness, Electric Stimulation Therapy, Early Mobility, Standard Rehabilitation Treatment
Medical subject headings
Muscle Weakness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • neuro muscular electro stimulationDevice

    Also called DEMAX® model Quatrum Duo

    We used a commercial equipment of electro stimulation with a pulse width of 300 micro seconds, a frequency of 50 Hz, with symmetrical balanced biphasic rectangular wave and with an intensity of up to 80 milliampere.

  • Early Mobilization protocolOther

    The protocol consisted in applying a specific treatment based on different levels of treatment to each subject. Admission to them was carried out according to the maximum capacity of each subject, the conditions of each level being the following:

    • Level 1: MRC (shoulder) <3 + MRC <3 (hip).
    • Level 2: MRC (shoulder) ≥ 3 + MRC (hip) <3.
    • Level 3: MRC (shoulder) ≥ 3 + MRC (hip) ≥ 3 + sitting on the edge of the bed without assistance (minimum 15 minutes).
    • Level 4: Standing without assistance and walking with or without assistance.

  • standard care or usual rehabilitationOther

    routine, non-protocolized rehabilitation treatment performed by the physiotherapist assigned to intensive care

Study groups in NCT04613908
Study groupRoleWhat they receive
standard care or usual rehabilitationActive comparatorIt will consist of the usual treatment performed by the intensive care physiotherapist, it will be applied every day that the study lasts.
Receives: Other: standard care or usual rehabilitation
neuro muscular electro stimulationExperimentalThey received 5 sessions per week (except weekends) of neuromuscular electrostimulation of 30 minutes duration. Also, every day that the study is carried out in the morning and in the afternoon, the subjects will receive the usual treatment performed by the intensive care physiotherapist.
Receives: Device: neuro muscular electro stimulation
early mobilization protocolExperimentalThroughout the duration of the study, an early mobilization protocol will be applied to apply a specific treatment based on different levels of treatment for each subject of the group; It differs from the usual procedure in protocolized progression according to the objectives reached by the patient, unlike the usual treatment, where the progression is in accordance with the clinical criteria of the treatment professional.
Receives: Other: Early Mobilization protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. days needs to revert ICUAW

    Number of days until reaching a value of the MRC-mss ≥ 48 points.

    Measured: 3 months

  2. Sessions needs to revert ICUAW

    Number of sessions until reaching a value of the MRC-mss ≥ 48 points.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2020
  2. Study start1 Aug 2015
  3. Primary completion31 Aug 2016
  4. Study completion31 Aug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
3 Groups Group 1 (GR-STD) received the standard or usual rehabilitation treatment used in our ICU as intervention. Group 2 (GR-NMES) received neuro muscular electro stimulation sessions in addition to the standard treatment. Group 3 (GR-EM) received an early mobilization protocol as intervention.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04613908
Sponsor's protocol ID
02-2018
Status last verified
Oct 2020
First submitted
21 Jun 2018
Last updated
3 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing neuro muscular electro stimulation and Early Mobilization protocol in people with Muscle Weakness and Rehabilitation, run by Hospital Nacional Profesor Alejandro Posadas.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

days needs to revert ICUAW (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04613908.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.

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