Bronchiectasis
Conditions
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.
Interventions
OTHERInspiratory 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.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Inspiratory Muscle Training With intervention.
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. | 13 |
| Control No intervention. | 13 |
| Total | 26 |
Baseline characteristics
| Characteristic | Inspiratory Muscle Training | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 13 Participants | 26 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 10 | 56 years STANDARD_DEVIATION 9 | 60 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 13 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 13 Participants | 26 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 13 participants | 13 participants | 26 participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
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.
Time frame: baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inspiratory Muscle Training | Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks | MIP baseline | 60 cmH2O | Standard Deviation 21 |
| Inspiratory Muscle Training | Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks | MIP at 8 weeks | 84 cmH2O | Standard Deviation 29 |
| Inspiratory Muscle Training | Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks | MEP at baseline | 72 cmH2O | Standard Deviation 31 |
| Inspiratory Muscle Training | Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks | MEP at 8 weeks | 104 cmH2O | Standard Deviation 35 |
| Control | Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks | MEP at 8 weeks | 88 cmH2O | Standard Deviation 24 |
| Control | Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks | MIP baseline | 71 cmH2O | Standard Deviation 16.4 |
| Control | Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks | MEP at baseline | 76 cmH2O | Standard Deviation 20 |
| Control | Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks | MIP at 8 weeks | 69 cmH2O | Standard Deviation 19 |
p-value: 0.005Regression, Linear
p-value: 0.038Regression, Linear
Secondary
6 Minute Work
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inspiratory Muscle Training | 6 Minute Work | baseline | 20140 Kg*Meter | Standard Deviation 7813 |
| Inspiratory Muscle Training | 6 Minute Work | 8 weeks | 22457 Kg*Meter | Standard Deviation 8596 |
| Control | 6 Minute Work | baseline | 21052 Kg*Meter | Standard Deviation 8286 |
| Control | 6 Minute Work | 8 weeks | 23915 Kg*Meter | Standard Deviation 8343 |
p-value: 0.269Regression, Linear
Secondary
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.
Time frame: baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inspiratory Muscle Training | Six Minutes Walking Distance | baseline | 427 meter | Standard Deviation 125 |
| Inspiratory Muscle Training | Six Minutes Walking Distance | 8 weeks | 447 meter | Standard Deviation 77 |
| Control | Six Minutes Walking Distance | baseline | 411 meter | Standard Deviation 133 |
| Control | Six Minutes Walking Distance | 8 weeks | 473 meter | Standard Deviation 117 |
p-value: 0.063Regression, Linear