Electric Muscle Stimulation for Patients With Chronic Respiratory Failure

NCT ID: NCT01930643

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-21
• Study Completion Date: 2015-06-30

Brief Summary

Background: After mechanical ventilation, 5-20% of patients with acute respiratory failure would depend on ventilator support more than 14 days because of critical-illness weakness and their underlying diseases such as heart failure and chronic obstructive pulmonary disease.

Hypothesis: Electric muscle stimulation(EMS) will improve their muscle strength and shorten their ventilator days.

Design: Randomized controlled trial. Adult patients with mechanical ventilation more than 14 days are eligible. EMS would be applied in experimental group 32 minutes/day on their bilateral thigh.

Detailed Description

Randomized controlled trial involves the adult patients with invasive mechanical ventilation more than 14 days. The participants were not eligible for active rehabilitation because of drowisness or weakness(Medical Research Council (MRC) Scale for Muscle Strength≦ Grade 3).

EMS would be applied in experimental group 32 minutes/day on their bilateral thigh(quadriceps muscle).

Conditions

Chronic Respiratory Failure; Critical Illness Myopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Electric muscle stimulation(EMS)

EMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week.

Group Type: EXPERIMENTAL

EMS

Intervention Type: DEVICE

HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day.

Control

Patients with routine passive rehabilitation program.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EMS

HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patient required mechanical ventilation more than 14 days
• No ability for active endurance exercise because of poor consciousness or limb weakness.

Exclusion Criteria

• Pregnant women
• Limb wound/infection interfered with electric pad application
• Recent acute myocardial infarction or life-threatening arrhythmia
• Uncontrolled epilepsy
• Dying patients without attempt of ventilator weaning
• Absence of respiratory drive

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kuang-Hua Cheng, MD

Visiting staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kuang H Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Mackay Memorial Hospital

Locations

Mackay Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

13MMHIS070

Identifier Type: -

Identifier Source: org_study_id