Rehabilitation of Patients With COPD Using Electrical Muscle Stimulation

NCT ID: NCT01799330

Last Updated: 2020-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2014-05-08

Brief Summary

The two hypotheses to be tested in this study are that:

1. The administration of transcutaneous electrical muscle stimulation (TCEMS) after completion of conventional exercise training in pulmonary rehabilitation (PR) will result in further improvements in exercise tolerance, functional status and symptoms of patients with stable chronic obstructive pulmonary disease (COPD) above those achieved in PR alone.

2. TCEMS can improve exercise tolerance, functional status and symptoms even among COPD patients who fail to make gains in exercise tolerance by participating in conventional PR due to their debilitation and/or marked cardio-respiratory impairment.

Detailed Description

Although a substantial body of evidence supports the existence of skeletal muscle dysfunction in COPD and the benefits of PR for these patients, the role of TCEMS as a routine rehabilitative strategy for patients with COPD has yet to be established. The studies proposed in this research will build on the knowledge gained in our previous study of TCEMS by investigating whether and how TCEMS adds to the beneficial effects of PR on exercise capacity and muscle function among outpatients with stable COPD, and by assessing for the first time whether TCEMS improves exercise tolerance and functional status among COPD patients unable to make gains following conventional outpatient PR. Thus, this proposed study may provide a novel strategy in the rehabilitation of patients with chronic lung disease.

The two specific aims of the proposed study are:

1. Determine whether administration of TCEMS after conventional exercise training in PR leads to added gains in muscle strength, exercise capacity, dyspnea and health status, to determine if TCEMS should be considered as an additional routine method in outpatient PR programs.

2. Determine whether patients who are unable to improve exercise tolerance during conventional exercise training in PR can achieve gains in muscle strength, exercise tolerance, dyspnea, and health status following TCEMS used as an alternate rehabilitative strategy.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1:Active TCEMS

Transcutaneous Electrical Muscle Stimulation (TCEMS): Group 1 will undergo TCEMS using an Omnistim FX-2 with two surface patch electrodes (8 x 6 cm) applied to each quadriceps, hamstring and calf muscles. The knee angle will remain at 90 degrees during simultaneous muscle stimulation to prevent joint movement. Electrical stimulation will be performed for 20 minutes on each limb, 3 days/week for 8 continuous weeks on an outpatient basis. The stimulator will be set to generate brief bursts of electrical impulses at 50Hz lasting 200 ms every 1500 ms. Muscles will be stimulated with an asymmetrical square wave pulse with an initial intensity set to create a visible contraction ranging from 55 mA to 120 mA.

Group Type: EXPERIMENTAL

Transcutaneous Electrical Muscle Stimulation (TCEMS)

Intervention Type: PROCEDURE

Group 2: Sham TCEMS

Patients randomized to Group 2 (Sham TCEMS) will receive the identical set-up for active TCEMS except they will receive a minimal electrical stimulus that does not produce a motor response.

Group Type: PLACEBO_COMPARATOR

Sham TCEMS

Intervention Type: OTHER

Patients randomized to Group 2 (Sham TCEMS) will receive the identical set-up for active TCEMS except they will receive a minimal electrical stimulus that does not produce a motor response

Interventions

Transcutaneous Electrical Muscle Stimulation (TCEMS)

Intervention Type: PROCEDURE

Sham TCEMS

Patients randomized to Group 2 (Sham TCEMS) will receive the identical set-up for active TCEMS except they will receive a minimal electrical stimulus that does not produce a motor response

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Pulmonary function test criteria consistent with a diagnosis of COPD including forced expiratory volume in one second (FEV1) < 65% of predicted, with FEV1/FVC (forced vital capacity) ratio < 70%, lung hyperinflation based on a residual volume to total lung capacity (RV/TLC) ratio > 120% predicted and reduced diffusing capacity for carbon monoxide (DLCO <70% predicted).

Self-reported exercise limitation despite pharmacologic treatment.

Otherwise medically stable.

Women and minorities will also be recruited. Only persons able to give fully informed consent will be enrolled in the study.

Exclusion Criteria

Patients will be excluded from study participation if they have a history of uncontrolled cardiovascular disease (including ventricular arrhythmia, myocardial infarction within 1 year, unstable angina, cardiac pacemaker or other implanted electrical device, other uncontrolled arrhythmias, or unstable blood pressure), neuromuscular disease (including stroke), debilitating joint disease or amputations that precludes exercise or have other contraindications to participating in outpatient PR (including unstable bone fracture, syncope of unclear etiology or cancer undergoing active chemotherapy), or are pregnant. Persons with a history of seizure disorder, intracranial clips or skin problems that would prevent safe or proper placement of the electrodes needed for electrical stimulation of the leg muscles will be excluded, based on prior clinical studies of TCEMS in non-COPD populations. Patients will also be excluded from study participation if they have undergone formal PR within 1 year of the date of study inclusion. No patients will be recruited from a "vulnerable patient population", including economically or educationally disadvantaged or mentally disabled persons, children, or prisoners.

• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Connecticut Healthcare System

FED

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carolyn L Rochester, MD

Role: PRINCIPAL_INVESTIGATOR

VA Connecticut Healthcare System/ Yale University School of Medicine

Locations

VA Connecticut Healthcare System

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

0809004250

Identifier Type: -

Identifier Source: org_study_id