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Effects of Inspiratory Muscle Training in Patients With Bronchiectasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meng-Chih LIn, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00952718
First received: August 3, 2009
Last updated: February 13, 2014
Last verified: February 2014

August 3, 2009
February 13, 2014
January 2008
December 2008   (final data collection date for primary outcome measure)
Evidence of clinically effectiveness with inspiratory muscle training [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00952718 on ClinicalTrials.gov Archive Site
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Not Provided
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Effects of Inspiratory Muscle Training in Patients With Bronchiectasis
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Bronchiectasis
Other: Inspiratory muscle training
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 Name: Pulmonary Rehabilitation
  • No Intervention: Control
    No intervention.
  • Experimental: Inspiratory muscle training
    With intervention.
    Intervention: Other: Inspiratory muscle training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
March 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00952718
CMRP-IRB-97-0458B
No
Meng-Chih LIn, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
Not Provided
Principal Investigator: Meng-Chih Lin, MD Chang Gung Memorial Hospital-Kaohsiung Medical Center
Chang Gung Memorial Hospital
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP