Rehabilitation of Patients With COPD Using Electrical Muscle Stimulation

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.

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.