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Completed

NCT Number: NCT01056081

Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: IMT

Primary outcomes

  1. Inspiratory muscle strength

    Time frame: 8 weeks

Secondary outcomes

  1. Exercise capacity

    Time frame: 8 weeks

  2. Dyspnea

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Faculdade Evangelica do Parana

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 26, 2010
Registry last updated
Jan 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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