Effects of Inspiratory Muscle Training in Patients With Bronchiectasis

Not Applicable

Completed

• Conditions: Bronchiectasis
• Interventions: Other: Inspiratory muscle training

• Registration Number: NCT00952718
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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.

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-12
• Study Completion: 2009-03
• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-04
• Study First Posted: 2009-08-06
• Results First Submitted: 2019-08-12
• Results First Submitted QC: 2019-09-26
• Results First Posted: 2019-10-21
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inspiratory muscle training	Inspiratory muscle training	With intervention.

Primary Outcome Measures

Name	Time	Method
Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks	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 Outcome Measures

Name	Time	Method
Six Minutes Walking Distance	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.
6 Minute Work	baseline and 8 weeks	The 6-minute walk work (6Mwork) value was calculated as body mass distance covered during the 6-minute walking test.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital-Kaohsiung Medical Center; 🇨🇳 Kaohsiung, Taiwan