Neuromuscular Stimulation in Chronic Obstructive Pulmonary Disease (COPD): A Pilot Study - Full Text View

Sponsored by:	Fondazione Salvatore Maugeri
Information provided by:	Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier:	NCT00677690

Purpose

To elucidate whether combination of usual pulmonary rehabilitation and neuromuscular electrical stimulation of quadriceps may improve exercise capacity in COPD patients.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Behavioral: Neuromuscular stimulation plus pulmonary rehabilitation Behavioral: Pulmonary rehabilitation	Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Exercise and Physical Fitness Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Combination of Neuromuscular Electrical Stimulation and Pulmonary Rehabilitation in COPD Patients: A Pilot Study

Further study details as provided by Fondazione Salvatore Maugeri:

Primary Outcome Measures:

to investigate whether combination of neuromuscular stimulation and pulmonary rehabilitation significantly improve exercise capacity in COPD patients [ Time Frame: after the training ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To investigate whether combination of neuromuscular stimulation and pulmonary rehabilitation significantly improve BODE index in COPD patients [ Time Frame: after the training ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	April 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation	Behavioral: Neuromuscular stimulation plus pulmonary rehabilitation Training of lower extremities combined with neuromuscular electrical stimulation (25 minutes twice daily 5 days/week for 5 weeks).
2: Placebo Comparator patients undergone to pulmonary rehabilitation	Behavioral: Pulmonary rehabilitation Training of lower extremities, i.e. two daily walks on treadmill 5 days/week for 5 weeks.

Detailed Description:

Stable COPD patients will be randomly assign to receive usual pulmonary rehabilitation alone (PR) or in combination with quadriceps neuromuscular electrical stimulation (NM+PR). The distance walked and rating of dyspnoea as primary outcomes, and BODE index as a secondary outcome will be record at the beginning and at the end of training.

Eligibility

Ages Eligible for Study:	60 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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; and need for treatment with systemic steroids during the rehabilitation period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677690

Contacts

Contact: claudio fracchia, MD

39-385-247 ext 244

cfracchia@fsm.it

Locations

Italy, Pavia
Fondazione Salvatore Maugeri	Recruiting
Montescano, Pavia, Italy, 27040
Contact: claudio fracchia, MD 39-385-247 ext 244 cfracchia@fsm.it
Principal Investigator: ercole zanotti, MD

Sponsors and Collaborators

Fondazione Salvatore Maugeri

Investigators

Principal Investigator:

ercole zanotti, MD

Fondazione Maugeri

More Information

Responsible Party:	Fondazione S. Maugeri ( ercole zanotti, MD )
Study ID Numbers:	05/2008
Study First Received:	May 8, 2008
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00677690
Health Authority:	Italy: Ethics Committee

Keywords provided by Fondazione Salvatore Maugeri:

COPD

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 14, 2009