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
  Purpose

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.


Condition Intervention
Bronchiectasis
Other: Inspiratory muscle training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Inspiratory Muscle Training in Patients With Bronchiectasis

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Evidence of clinically effectiveness with inspiratory muscle training [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
No intervention.
Experimental: Inspiratory muscle training
With intervention.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00952718

Locations
Taiwan
Chang Gung Memorial Hospital-Kaohsiung Medical Center
Niaosung Shiang, Kaohsiung, Taiwan, 833
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Meng-Chih Lin, MD Chang Gung Memorial Hospital-Kaohsiung Medical Center
  More Information

No publications provided

Responsible Party: Meng-Chih LIn, Vice Director, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00952718     History of Changes
Other Study ID Numbers: CMRP-IRB-97-0458B
Study First Received: August 3, 2009
Last Updated: February 13, 2014
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Respiratory Aspiration
Bronchiectasis
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases

ClinicalTrials.gov processed this record on August 28, 2014