Rehabilitation of Patients With COPD Using Electrical Muscle Stimulation

NCT01799330 | Completed

• 1 other identifier: 0809004250
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 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.

Conditions

COPD

Keywords

COPD; Rehabilitation; Exercise; TCEMS

Outcome Measures

Primary Outcomes (1)

• Incremental Shuttle Walk Test (SWT)

  The incremental Shuttle Walk Test will be used as a measure of exercise capacity. This test measures the maximal distance walked by the patient around two position markers set 10 meters apart, at a pace set by audio signals from a cassette tape. Minute-by-minute walking speed is increased until the patient feels too tired or short of breath to continue, or is unable to walk at least half of the 10 meter distance by the time the next audio signal is heard. Patients who routinely use supplemental oxygen will perform the test while carrying their portable oxygen delivery system during testing. As noted above, a practice run will be performed on the day the patient comes in for familiarization with the protocol and equipment. The investigator conducting the Shuttle Walk Test will be blinded to the groupings of subjects to avoid potential bias of the results.

  Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS

Secondary Outcomes (9)

• Body Composition

  Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS

• Body Mass Index (BMI)

  Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS

• Pulmonary Function

  Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS

• Muscle Strength

  Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS

• Six Minute Walk Test (6MWT) and Borg Dyspnea Rating

  Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS

Study Arms (2)

Group 1:Active TCEMS

EXPERIMENTAL

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.

Procedure: Transcutaneous Electrical Muscle Stimulation (TCEMS)

Group 2: Sham TCEMS

PLACEBO COMPARATOR

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.

Other: Sham TCEMS

Interventions

Transcutaneous Electrical Muscle Stimulation (TCEMS) PROCEDURE

Group 1:Active TCEMS

Sham TCEMS 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

Group 2: Sham TCEMS

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• VA Connecticut Healthcare System: collaborator

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Carolyn L Rochester, MD

  VA Connecticut Healthcare System/ Yale University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: February 26, 2013
• Study Start: December 1, 2008
• Primary Completion: May 8, 2014
• Study Completion: May 8, 2014
• Last Updated: September 28, 2020

Record last verified: 2020-09

Locations

US (1)