Electrical Stimulation to Strengthen Muscles in the Lower Legs in Patients Requiring Prolonged Mechanical Ventilation

Not Applicable

Completed

• Conditions: Muscle Weakness
• Interventions: Device: Neuromuscular electrical stimulation; Device: sham stimulation

• Registration Number: NCT01825135
• Lead Sponsor: RML Specialty Hospital

Brief Summary

The primary aim of this proposal is to test the effectiveness of NMES in improving functional status and muscle function in patients requirng prolonged mechanical ventilation

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2013-03-28
• Study First Submitted QC: 2013-04-02
• Study First Posted: 2013-04-05
• Primary Completion: 2014-10
• Study Completion: 2016-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• duration of mechanical ventilation for 14 days or more
• sufficiently awake
• able to speak and comprehend English

Exclusion Criteria

• known primary neuromuscular disease
• lower extremities paresis or amputee
• patients with left-ventricular assist device (LVAD)
• cardiopulmonary instability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neuromuscular electrical stimulation	Neuromuscular electrical stimulation	Neuromuscular electrical stimulation (NMES) will be applied to the quadriceps muscles for 30 minutes
Sham stimulation	sham stimulation	Sham stimulation will be applied to the quadriceps for 30 minutes

Primary Outcome Measures

Name	Time	Method
modified Functional Independence Measurement (FIM) score	Hospital discharge, an expected average stay of 5 weeks	Functional status as measured by modified Functional Independence Measurement (FIM) score

Trial Locations

Locations (1)

RML Specialty Hospital; 🇺🇸 Hinsdale, Illinois, United States