Rehabilitation of Patients With COPD Using Electrical Muscle Stimulation

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

COPD

Clinical Trial Details

NCT number	NCT01799330
Study type	Interventional
Source	Yale University
Contact
Status	Completed
Phase	N/A
Start date	December 2008
Completion date	May 8, 2014

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.