Respiratory Muscle Stretching in Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Respiratory Muscle Stretching in Patients With Chronic Obstructive Pulmonary Disease Submitted a Pulmonary Rehabilitation Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935181
• Other study ID #: 3145/06
• Status: Completed
• Phase: Phase 4
• First received: June 29, 2009
• Last updated: July 7, 2009
• Start date: January 2006
• Est. completion date: December 2008

Study information

• Verified date: July 2009
• Source: Faculdade Evangelica do Parana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Objective: The investigators studied the effects of respiratory muscle stretching in an 8-week pulmonary rehabilitation program. Methods: This was a simple-blind parallel controlled trial, conducted an out-patient clinic. Twenty six patients with COPD (mean age 68 ± 6 y, percent of predicted FEV1 47 ± 16) were randomized to either respiratory muscle stretching group plus exercise training (RMS), and exercise training group (Sham), in an 8-week exercise program that had 3 sessions per week. The investigators measured inspiratory and expiratory muscle strength (by maximal inspiratory and expiratory pressure - PIM and PEM), exercise capacity (by 6-minute walk distance), dyspnea and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2008
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subjects between 40 and 75 years of age referred by a physician to the Pulmonary Rehabilitation Program

• With a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD), in a stable condition (without exacerbations or infections for at least a month)

• Former smokers

Exclusion Criteria:

• Patients with a known history of asthma, or severe and/or unstable heart disease

• Any other pathological condition that could impair their physical activities

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• respiratory muscle stretching
stretching exercises for respiratory muscles like diaphragm, pectoral, dorsalis etc

Locations

Country	Name	City	State
Brazil	Faculdade Evangelica do Paraná	Curitiba	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade Evangelica do Parana

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory muscle strength		2 hours	No
Secondary	Exercise capacity		2 hours	No