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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03083652

Enrollment

Registered

2017-03-20

Start date

2017-02-01

Completion date

2024-06-01

Last updated

2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness Myopathy

Keywords

physiotherapy, neuromuscular electrical stimulation, exercise capacity

Brief summary

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.

Interventions

DEVICENeuromuscular electrical stimulation

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

OTHERSham

Conventional physiotherapy with NMES device NOT activated

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Exercise capacity	<48h from ICU discharge	Test sit-to-stand

Secondary

Measure	Time frame	Description
Muscle strength	1st day in which collaboration of the patient is ensured (through standardized 5 questions)	MRC score
Body composition (fat free mass)	<48h from inclusion	Bioelectrical impedance
Functional Capacity	<24h from inclusion	Barthel scale

Countries

Spain

Contacts

Primary ContactJoan-Daniel Martí, PT,PhD

jd.martibcn@gmail.com0034932275400

Backup ContactJavi Martinez, PT

javimagu8@gmail.com0034687219761

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026