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

NCT ID: NCT02332187

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-03
• Study Completion Date: 2017-05-05

Brief 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.

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.

Conditions

Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Sham electrical stimulation using an All Stim stimulator

Intervention Type: DEVICE

With this intervention the All Stim unit is turned off and no electrical stimulation is provided.

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.

Group Type: ACTIVE_COMPARATOR

Active electrical stimulation using an All Stim stimulator

Intervention Type: DEVICE

This is an FDA approved stimulator that is used for strengthening the quadriceps muscle.

Interventions

Active electrical stimulation using an All Stim stimulator

This is an FDA approved stimulator that is used for strengthening the quadriceps muscle.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gerald Supinski

OTHER

Sponsor Role: lead

Responsible Party

Gerald Supinski

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gerald S Supinski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

Chandler Hospital

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Protocol 12-0807-F6A

Identifier Type: -

Identifier Source: org_study_id