Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Inspiratory Muscle Training for Patients With Chronic Obstructive Pulmonary Disease Undergoing a Pulmonary Rehabilitation Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056081
• Other study ID #: FEPAR 1768
• Status: Completed
• Phase: Phase 3
• First received: January 22, 2010
• Last updated: January 25, 2010
• Start date: April 2006
• Est. completion date: December 2008

Study information

• Verified date: March 2006
• 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

Uncertainty persists regarding the usefulness of incorporating inspiratory muscle training (IMT) in pulmonary rehabilitation programs for patients with chronic obstructive pulmonary disease. In this study the investigators investigate whether IMT associated with exercise training would be better than exercise training alone, with regard to exercise capacity, inspiratory muscle strength and dyspnea.

Description:

Study design: A double-blind parallel controlled trial Setting: outpatient clinic 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).

Outcome measurements: Inspiratory muscle strength (using maximal inspiratory pressure, MIP), exercise capacity (using six-minute walk test) and dyspnea were measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subjects 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)

• Had to be former smokers (> 6 months without smoking)

• subjects referred by a physician to the Pulmonary Rehabilitation Program

Exclusion Criteria:

• Subjects with a known history of asthma, or severe and/or unstable heart disease or any other pathological condition that could impair their physical activities

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Inspiratory muscle training
The training was performed using a threshold inspiratory muscle trainer (Respironics HealthScan, Inc, Cedar Grove, New York, USA). The patients performed the IMT training in a seated position, with the upper limbs supported. The total duration of the respiratory training was 30 minutes, with sequences of three minutes of training followed by pauses of two minutes. The initial load was equivalent to 30% of the individual's MIP. This load was progressively increased over the first four weeks, according to the patients' tolerance, to reach 60% of the MIP. This level was then maintained until the end of the training.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade Evangelica do Parana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory muscle strength		8 weeks	No
Secondary	Exercise capacity		8 weeks	No
Secondary	Dyspnea		8 weeks	No