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

Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02332187
• Other study ID #: Protocol 12-0807-F6A
• Status: Terminated
• Phase: N/A
• Start date: January 3, 2013
• Est. completion date: May 5, 2017

Study information

• Verified date: February 2022
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: May 5, 2017
• Est. primary completion date: May 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Weakness

Intervention

Device:
• Active electrical stimulation using an All Stim stimulator
This is an FDA approved stimulator that is used for strengthening the quadriceps muscle.
• Sham electrical stimulation using an All Stim stimulator
With this intervention the All Stim unit is turned off and no electrical stimulation is provided.

Locations

Country	Name	City	State
United States	Chandler Hospital	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Gerald Supinski

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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