Effects of Inspiratory Muscle Training in Patients With Bronchiectasis
1 other identifier
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 3, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedResults Posted
Study results publicly available
October 21, 2019
CompletedJuly 28, 2021
July 1, 2021
11 months
August 3, 2009
August 12, 2019
July 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 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.
baseline and 8 weeks
Secondary Outcomes (2)
Six Minutes Walking Distance
baseline and 8 weeks
6 Minute Work
baseline and 8 weeks
Study Arms (2)
Control
NO INTERVENTIONNo intervention.
Inspiratory muscle training
EXPERIMENTALWith intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Bronchiectasis confirmed by clinical history, pulmonary function test, and high resolution computed tomography
You may not qualify if:
- Had recent exacerbation within six weeks
- Use of corticosteroid
- With poor consciousness level
- Have cerebro-vascular or neuro-muscular disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital-Kaohsiung Medical Center
Kaohsiung City, 833, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Liaw MY
- Organization
- ChangGungMH
Study Officials
- PRINCIPAL INVESTIGATOR
Meng-Chih Lin, MD
Chang Gung Memorial Hospital-Kaohsiung Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Director
Study Record Dates
First Submitted
August 3, 2009
First Posted
August 6, 2009
Study Start
January 1, 2008
Primary Completion
December 1, 2008
Study Completion
March 1, 2009
Last Updated
July 28, 2021
Results First Posted
October 21, 2019
Record last verified: 2021-07