Effects of Inspiratory Muscle Training in Patients With Bronchiectasis
Primary Purpose
Bronchiectasis
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Inspiratory muscle training
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiectasis
Eligibility 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
Sites / Locations
- Chang Gung Memorial Hospital-Kaohsiung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Inspiratory muscle training
Arm Description
No intervention.
With intervention.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Six Minutes Walking Distance
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
The 6-minute walk work (6Mwork) value was calculated as body mass distance covered during the 6-minute walking test.
Full Information
NCT ID
NCT00952718
First Posted
August 3, 2009
Last Updated
July 26, 2021
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00952718
Brief Title
Effects of Inspiratory Muscle Training in Patients With Bronchiectasis
Official Title
Effects of Inspiratory Muscle Training in Patients With Bronchiectasis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention.
Arm Title
Inspiratory muscle training
Arm Type
Experimental
Arm Description
With intervention.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training
Other Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks
Description
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.
Time Frame
baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Six Minutes Walking Distance
Description
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.
Time Frame
baseline and 8 weeks
Title
6 Minute Work
Description
The 6-minute walk work (6Mwork) value was calculated as body mass distance covered during the 6-minute walking test.
Time Frame
baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng-Chih Lin, MD
Organizational Affiliation
Chang Gung Memorial Hospital-Kaohsiung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital-Kaohsiung Medical Center
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
12. IPD Sharing Statement
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Effects of Inspiratory Muscle Training in Patients With Bronchiectasis
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