Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease

NCT01056081 | Completed Phase 3 DMC

• 1 other identifier: FEPAR 1768
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; inspiratory muscles; diaphragm

Outcome Measures

Primary Outcomes (1)

• Inspiratory muscle strength

  8 weeks

Secondary Outcomes (2)

• Exercise capacity

  8 weeks

• Dyspnea

  8 weeks

Study Arms (1)

Inspiratory muscle training

EXPERIMENTAL

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.

Other: Inspiratory muscle training

Interventions

Inspiratory muscle training OTHER

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.

Also known as: IMT

Inspiratory muscle training

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculdade Evangelica do Parana: lead

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

Study Officials

• Silvia R Valderramas, PhD

  Evangelical Faculty of Paraná

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 22, 2010
• First Posted: January 26, 2010
• Study Start: April 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 26, 2010

Record last verified: 2006-03