Efficacy of Different Treatments for the Intensive Care Unit Acquired Weakness

NCT04613908 | Completed

• 1 other identifier: 02-2018
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Muscle Weakness; Rehabilitation

Keywords

Intensive Care Unit Acquired Weakness; Electric Stimulation Therapy; Early Mobility; Standard Rehabilitation Treatment

Outcome Measures

Primary Outcomes (2)

• days needs to revert ICUAW

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

  3 months

• Sessions needs to revert ICUAW

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

  3 months

Study Arms (3)

standard care or usual rehabilitation

ACTIVE COMPARATOR

It will consist of the usual treatment performed by the intensive care physiotherapist, it will be applied every day that the study lasts.

Other: standard care or usual rehabilitation

neuro muscular electro stimulation

EXPERIMENTAL

They 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.

Device: neuro muscular electro stimulation

early mobilization protocol

EXPERIMENTAL

Throughout 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.

Other: Early Mobilization protocol

Interventions

neuro muscular electro stimulation DEVICE

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.

Also known as: DEMAX® model Quatrum Duo

neuro muscular electro stimulation

Early Mobilization protocol OTHER

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.

early mobilization protocol

standard care or usual rehabilitation OTHER

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

standard care or usual rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Hospital Nacional Profesor Alejandro Posadas: lead

MeSH Terms

Conditions

Muscle Weakness

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ladislao P Diaz Ballve

  Hospital Nacional Posadas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the person in charge of performing the statistical analysis was blind, by coding the interventions in the database.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: November 3, 2020
• Study Start: August 1, 2015
• Primary Completion: August 31, 2016
• Study Completion: August 31, 2016
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share