Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02847988

Enrollment

200

Registered

2016-07-28

Start date

2016-07-31

Completion date

2022-04-30

Last updated

2021-03-11

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

Conditions

Muscle Weakness

Keywords

muscle strength, muscle function, functional status

Brief summary

The primary aim of this proposal is to test the effectiveness of neuromuscular electrical stimulation (NMES) in improving functional status and muscle function in patients receiving prolonged mechanical ventilation.

Interventions

DEVICENeuromuscular electrical Stimulation (NMES)

Electrical stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo). The intensity of stimulation will be titrated based on maximal tolerable muscle contraction

DEVICESham Stimulation

Sham stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Duration of mechanical ventilation \>14 days * Sufficiently awake * Able to speak and comprehend English * Willingness to participate

Exclusion criteria

* Cardiopulmonary Instability * Acute-onset neuromuscular disease * Lower-extremity amputee or paresis * Open wound at electrode application points * Pitting edema grade ≥3 * Presence of pacemaker, implanted defibrillator, or ventricular-assist device * inability to transfer from sitting to standing before critical illness

Design outcomes

Primary

Measure	Time frame	Description
Time to reach independence in performing functional activity	Hospital discharge, an expected average stay of 5 weeks	Functional activity as measured by functional activity measurement for the ICU (FSS-ICU)

Secondary

Measure	Time frame	Description
The percentage of patients who can perform functional activities independently	Hospital discharge, an expected average stay of 5 weeks	Percentage of patients with an FSS-ICU score ≥ 25 at discharge from LTACH

Countries

United States

Contacts

Primary ContactLisa A Duffner, B.A.,B.S.

lmikolajewski@rmlspecialtyhospital.org630-286-4149

Backup ContactAmal Jubran, MD

ajubran@lumc.edu708-202-2705

Outcome results

None listed

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