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Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
neuromuscular electrical stimulation (NMES)
Sham electrical stimulation
Sponsored by
Fondazione Salvatore Maugeri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of COPD
  • Must be able to walk

Exclusion Criteria:

  • Previous or current diagnosis of chronic respiratory failure
  • A history of diseases other than COPD, in particular neurological disease
  • Need for treatment with systemic steroids during the rehabilitation period

Sites / Locations

  • Fondazione Salvatore Maugeri

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

NM+PR

SS+PR

Arm Description

Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation (NM+PR)

Patients undergone to pulmonary rehabilitation

Outcomes

Primary Outcome Measures

Exercise Capacity
6 minute walk test(6MWT)
Quadriceps Strength
Quadriceps strength was assessed by means of Sit to Stand Test (STST). The subjects held their arms stationary by putting their hands on their hips. The subjects were asked to complete the sitting and standing positions without using the arms for support while rising and sitting. Once instructed, subjects stand upright and without delay sit down again, repeating the procedure as many times as possible in a 1 min period. The number of completed repetitions was recorded. The subjects were permitted to use rest periods to complete 1 min.

Secondary Outcome Measures

Dyspnoea
The modified Medical Research Council (MMRC) scale was used for rating dyspnoea. MMRC is a five-point scale based on degrees of various physical activities that precipitate breathlessness. Scores on the MMRC dyspnoea scale can range from 0 (normal) to 4.
Quality of Life
St. George's respiratory questionnaire is a standardized self-administered airways disease-specific questionnaire divided into three subscales: symptoms (eight items), activity (16 items), and impacts (26 items). For each subscale and for the overall questionnaire, scores range from zero (no impairment) to 100 (maximum impairment).
Respiratory Function
forced expiratory volume in 1 second (FEV1)

Full Information

First Posted
May 8, 2008
Last Updated
November 4, 2011
Sponsor
Fondazione Salvatore Maugeri
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1. Study Identification

Unique Protocol Identification Number
NCT00677690
Brief Title
Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Combination of Pulmonary Rehabilitation and Neuromuscular Electrical Stimulation and in COPD Patients: a Randomized Clinical Trial of Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Salvatore Maugeri

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to elucidate whether combination of usual pulmonary rehabilitation and neuromuscular electrical stimulation of quadriceps may improve exercise capacity in patients affected by chronic obstructive pulmonary disease (COPD).
Detailed Description
Neuromuscular electrical stimulation (NMES) has been extensively used as technique to improve muscle function in different areas of rehabilitation, however it seems to be more appropriate in critical care situation, while its use in more able patients is of uncertain benefit. In other words, NMES seems to be particularly effective in severely deconditioned and bed ridden patients. We therefore carried out a randomised trial to compare the efficacy of combination of NMES and PR (NM+PR) with combination of sham stimulation and PR (SS+PR) in a large population of moderately impaired COPD patients. Primary outcome was evaluation of effect of NMES on quadriceps strength and on exercise capacity. Secondary outcome was evaluation of effect of NMES on symptoms (dyspnoea) and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NM+PR
Arm Type
Active Comparator
Arm Description
Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation (NM+PR)
Arm Title
SS+PR
Arm Type
Placebo Comparator
Arm Description
Patients undergone to pulmonary rehabilitation
Intervention Type
Other
Intervention Name(s)
neuromuscular electrical stimulation (NMES)
Other Intervention Name(s)
pulmonary rehabilitation
Intervention Description
NMES was applied by means of a commercially available four channel electrostimulator which generated a symmetrical biphasic pulsed current. Each session lasted 30 minutes and was performed 5 days/week for 5 weeks.
Intervention Type
Other
Intervention Name(s)
Sham electrical stimulation
Other Intervention Name(s)
pulmonary rehabilitation
Intervention Description
Sham stimulation was performed with the same modality and time, but the stimulus was set up at 5 Hz.
Primary Outcome Measure Information:
Title
Exercise Capacity
Description
6 minute walk test(6MWT)
Time Frame
5 weeks
Title
Quadriceps Strength
Description
Quadriceps strength was assessed by means of Sit to Stand Test (STST). The subjects held their arms stationary by putting their hands on their hips. The subjects were asked to complete the sitting and standing positions without using the arms for support while rising and sitting. Once instructed, subjects stand upright and without delay sit down again, repeating the procedure as many times as possible in a 1 min period. The number of completed repetitions was recorded. The subjects were permitted to use rest periods to complete 1 min.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Dyspnoea
Description
The modified Medical Research Council (MMRC) scale was used for rating dyspnoea. MMRC is a five-point scale based on degrees of various physical activities that precipitate breathlessness. Scores on the MMRC dyspnoea scale can range from 0 (normal) to 4.
Time Frame
5 weeks
Title
Quality of Life
Description
St. George's respiratory questionnaire is a standardized self-administered airways disease-specific questionnaire divided into three subscales: symptoms (eight items), activity (16 items), and impacts (26 items). For each subscale and for the overall questionnaire, scores range from zero (no impairment) to 100 (maximum impairment).
Time Frame
5 weeks
Title
Respiratory Function
Description
forced expiratory volume in 1 second (FEV1)
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of COPD Must be able to walk Exclusion Criteria: Previous or current diagnosis of chronic respiratory failure A history of diseases other than COPD, in particular neurological disease Need for treatment with systemic steroids during the rehabilitation period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ercole zanotti, MD
Organizational Affiliation
Fondazione Maugeri
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Salvatore Maugeri
City
Montescano
State/Province
Pavia
ZIP/Postal Code
27040
Country
Italy

12. IPD Sharing Statement

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Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)

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