Effect of All-Stim 2 Quadriceps Treatments on Limb Muscle Strength In Mechanically Ventilated Patients

Effect of All-Stim 2 Quadriceps Treatments on Limb Muscle Strength In Mechanically Ventilated Patients.

Patients that are on mechanical ventilators in medical intensive care units (MICU) have extremely weak leg muscles. Currently there is no treatment to prevent or reverse this weakness. Treatments with a thigh muscle stimulator, called an All Stim 2, can improve leg muscle strength and help patients regain leg function after knee surgery. The purpose of the present study is to determine if treatments with the All Stim 2 device can also improve leg muscle strength in patients on mechanical ventilation.

Study Overview

• Status: Terminated
• Conditions: Weakness
• Intervention / Treatment: Device: Sham electrical stimulation using an All Stim stimulator; Device: Active electrical stimulation using an All Stim stimulator

Detailed Description

The objective for this study is to determine if daily exercise using All-Stim 2 stimulation of quadriceps muscles will increase leg strength and improve outcomes (duration of hospitalization, long term mobility, long term disability) for mechanically ventilated MICU patients. The investigators plan to randomize patients accepted into this protocol to administration of either sham exercise (i.e. placement of All-Stim 2 units on the legs for 30 minutes a day without activation of the electrical stimulation program) or active exercise (placement of All-Stim 2 electrodes on both legs and stimulating quadriceps muscles to rhythmically contract for 30 minutes a day). The two groups (sham and active exercise) will be treated for 30 minutes a day for seven days. The effects of exercise on quadriceps strength will be assessed by measuring quadriceps force generation (QuadTw) in response to magnetic stimulation of the femoral nerves. The QuadTw assessment will be made immediately before institution of sham or active exercise and will repeated one day after the conclusion of the seven day training regimen. Chart review and patient follow-up will be used to determine if this treatment regimen also has an impact on clinical outcome measures, i.e. duration of hospitalization.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Chandler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients requiring mechanical ventilation for more than 48 hours
• Respiratory failure present

Exclusion Criteria:

• The physician caring for the patient determines that the patient is too unstable
• Use of high dose pressors (more than 15 mcg/min of norepinephrine or more than 15 mg/kg/min of dopamine)
• Use of more than 80% FiO2 (fractional concentration of oxygen) or more than 15 cm H2O (water) of PEEP (positive end expiratory pressure)
• Presence of a cardiac pacemaker or implanted defibrillator
• Use of neuromuscular blocking agents within the 48 hours preceding testing
• History of a preexisting neuromuscular disease
• Presence of profound and uncorrectable hypokalemia (less than 2.5) or hypophosphatemia (less than 1.0)
• Pregnancy
• If the patient is a prisoner
• If the patient is institutionalized
• If it is thought that the patient will have care withdrawn within 7 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham electrical stimulation; The intervention will consist of sham electrical stimulation using an All Stim stimulator of each quadriceps leg muscle for 30 minutes per day for a total of 7 days.	Device: Sham electrical stimulation using an All Stim stimulator; With this intervention the All Stim unit is turned off and no electrical stimulation is provided.
Active Comparator: Active electrical stimulation; The intervention will consist of active electrical stimulation using an All Stim stimulator of each quadriceps leg muscle for 30 minutes per day for a total of 7 days.	Device: Active electrical stimulation using an All Stim stimulator; This is an FDA approved stimulator that is used for strengthening the quadriceps muscle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quadriceps Muscle Strength	The investigators will measure quadriceps leg strength before and after one week of either sham or active electrical stimulation of the quadriceps muscle.	Baseline and One week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Hospitilization	The investigators will record the total time patients remain hospitilized after entry into the study.	Baseline to discharge in weeks, up to five weeks

Collaborators and Investigators

• Sponsor: Gerald Supinski
• Investigators: Principal Investigator: Gerald S Supinski, MD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2013
• Primary Completion (Actual): May 5, 2017
• Study Completion (Actual): May 5, 2017

Study Registration Dates

• First Submitted: December 30, 2014
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Protocol 12-0807-F6A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will provide de-identified data to other researchers on request. We cannot, however, under the terms of our IRB approval, provide primary data which contains information that may identify participants. Data will be released once the paper is accepted for publication.
• IPD Sharing Time Frame: January 2019
• IPD Sharing Access Criteria: Any researcher associated with a University or Pharmaceutical company
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes