Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Inspiratory muscle training

• Registration Number: NCT01056081
• Lead Sponsor: Faculdade Evangelica do Parana

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2006-03
• Study Start: 2006-04
• Primary Completion: 2008-04
• Study Completion: 2008-12
• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-01-25
• Last Update Submitted: 2010-01-25
• Study First Posted: 2010-01-26
• Last Update Posted: 2010-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inspiratory muscle training	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.

Primary Outcome Measures

Name	Time	Method
Inspiratory muscle strength	8 weeks

Secondary Outcome Measures

Name	Time	Method
Dyspnea	8 weeks
Exercise capacity	8 weeks