Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)

NCT00677690 | Completed Phase 3 Results

• 1 other identifier: 05/2008
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (2)

• Exercise Capacity

  6 minute walk test(6MWT)

  5 weeks

• 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.

  5 weeks

Secondary Outcomes (3)

• Dyspnoea

  5 weeks

• Quality of Life

  5 weeks

• Respiratory Function

  5 weeks

Study Arms (2)

NM+PR

ACTIVE COMPARATOR

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

Other: neuromuscular electrical stimulation (NMES)

SS+PR

PLACEBO COMPARATOR

Patients undergone to pulmonary rehabilitation

Other: Sham electrical stimulation

Interventions

neuromuscular electrical stimulation (NMES) OTHER

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.

Also known as: pulmonary rehabilitation

NM+PR

Sham electrical stimulation OTHER

Sham stimulation was performed with the same modality and time, but the stimulus was set up at 5 Hz.

Also known as: pulmonary rehabilitation

SS+PR

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of COPD
• Must be able to walk

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Salvatore Maugeri: lead

Study Sites (1)

Fondazione Salvatore Maugeri

Montescano, Pavia, 27040, Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ercole Zanotti
• Organization: Fondazione Salvatore Maugeri, IRCCS, Pavia, Italy

ercole.zanotti@fsm.it

39 385 247

Study Officials

• ercole zanotti, MD

  Fondazione Maugeri

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 14, 2008
• Study Start: January 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: January 1, 2009
• Last Updated: November 16, 2011
• Results First Posted: April 20, 2009

Record last verified: 2011-11

Locations

IT (1)