Effects of Neuromuscular Electrical Stimulation on Exercise Capacity in Respiratory Critically Ill Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2024-06-01

Brief Summary

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Neuromuscular electrical stimulation (NMES) implemented during the intensive care unit(ICU) stay may improve exercise capacity and prevent muscular weakness in critically ill patients with respiratory disease. Main objective: To evaluate, in respiratory critically ill patients, the effects of a conventional physiotherapy program with or without additional NMES applied only during the ICU stay on exercise capacity. Design: Randomized, controlled, double-blind clinical trial on patients (\>18yo) with diagnosis on admission of acute or acute on chronic respiratory disease, on mechanical ventilation (MV) \> 72h and expected MV \> 24h. Intervention: Conventional physiotherapy with or without 30-minutes (5days/week) on quadriceps femoris and gluteus maximus. Patients in the control group will follow the same protocol but the device will not be activated. Measures: Demographic data, body composition through bioelectrical impedance analysis (BIA), and functional capacity before admission through Barthel scale will be registered upon inclusion. Exercise capacity through test sit-to stand, muscular strength through Medical Research Council (MRC) score and dynamometry, body composition through BIA, and functional capacity through Barthel scale will be obtained at ICU and hospital discharge.

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Detailed Description

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Conditions

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Critical Illness Myopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

Conventional physiotherapy with NMEs device not activated

Group Type SHAM_COMPARATOR

Sham

Intervention Type OTHER

Conventional physiotherapy with NMES device NOT activated

Intervention

Conventional physiotherapy with daily 30-minutes NMEs (5 days/week)

Group Type EXPERIMENTAL

Neuromuscular electrical stimulation

Intervention Type DEVICE

Neuromuscular electrical stimulation (30 minutes per day, 5 days/week) of the quadriceps femoris and gluteus maximus

Interventions

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Neuromuscular electrical stimulation

Neuromuscular electrical stimulation (30 minutes per day, 5 days/week) of the quadriceps femoris and gluteus maximus

Intervention Type DEVICE

Sham

Conventional physiotherapy with NMES device NOT activated

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis at admission: acute or acute on chronic respiratory disease
* Mechanical ventilation \> 72h at inclusion
* Expected mechanical ventilation \> 24h
* Informed consent

Exclusion Criteria

* Patients re-admitted to ICU (no hospital discharge)
* Exitus or transfer to another service/hospital
* Respiratory instability \[Inspired fraction of oxygen (FIO2) \>60% or positive end-expiratory pressure (PEEP) \>10 cmH2O\] and/or hemodynamic instability \[Mean arterial pressure ( MAP)\<60mmHg although vasoactive drugs\] during \> 24h.
* Pregnancy
* Neuromuscular disease before admission
* Skin lesions
* Limitation of therapeutic effort
* Mental and/or physical limitation to understand/realize tests for evaluation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No