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Completed

NCT Number: NCT00952718

Effects of Inspiratory Muscle Training in Patients With Bronchiectasis

The purpose of this study is to determine whether inspiratory muscle training could improve and/or prevent the deterioration of inspiratory muscle strength, clinical cardiopulmonary outcome, systemic immunologic responses and quality of life in patients with bronchiectasis.

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital-Kaohsiung Medical Center

Kaohsiung City, 833, Taiwan

About this study

Inspiratory muscle training is reportedly beneficial in patients with diverse chronic cardio-pulmonary diseases. It can increase inspiratory muscle strength and endurance, improves exercise capacity and quality of life (QOL), and decreases the perception of dyspnea (POD) for adults with stable chronic obstructive pulmonary disease (COPD). Though the pathophysiology in COPD and bronchiectasis are different, there are some similarities in clinical presentation. In COPD patients, lung hyperinflation induces functional weakness of the inspiratory muscle and increases elastic load to breathing and intrinsic positive end expiratory pressure. Patients with bronchiectasis shows reduced ratio of FEV1/FVC, reduced FEV1, and normal or slightly reduced FVC, which indicate that airways are blocked by mucus. However, there has been no study that used IMT as a training modality to determine its effect in bronchiectasis. The clinical relevance of increased respiratory muscle strength per se by IMT alone is unknown. This study tried to evaluate the feasibility and effectiveness of home-based threshold training and examined if the effects of IMT extends to clinical outcomes such as activities of daily living and QOL in bronchiectasis patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Bronchiectasis confirmed by clinical history, pulmonary function test, and high resolution computed tomography

Exclusion criteria

  • Had recent exacerbation within six weeks
  • Use of corticosteroid
  • With poor consciousness level
  • Have cerebro-vascular or neuro-muscular disorders

Treatment and study plan

Inspiratory Muscle Training

Other

A pressure threshold device (Threshold® IMT HS730, RESPIRONICS Inc, Cedar Grove, NJ, USA) was used for the inspiratory muscle training program. The individualized training program was started at an intensity of 30% MIP, which was increased by 2 cmH2O each week, but the maximal intensity did not exceed 50% of MIP. Patients were encouraged to perform IMT for 30 minutes per day, at least 5 days a week for 8 weeks.

Other names: Pulmonary Rehabilitation

Primary outcomes

  1. Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks

    Time frame: baseline and 8 weeks

    MEP was measured after maximal inspiration,while MIP was measured after maximal expiration with each subject seated and wearing a nose-clip. An experienced respiratory therapist strongly urged the subjects to make maximum inspiratory and expiratory efforts at or near residual and total lung capacity, respectively. Determinations were repeated until two technically satisfactory measurements were recorded, with the highest value used for calculations.

Secondary outcomes

  1. Six Minutes Walking Distance

    Time frame: baseline and 8 weeks

    The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

  2. 6 Minute Work

    Time frame: baseline and 8 weeks

    The 6-minute walk work (6Mwork) value was calculated as body mass distance covered during the 6-minute walking test.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Aug 6, 2009
Registry last updated
Jul 28, 2021

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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