Trial Outcomes & Findings for Effects of Inspiratory Muscle Training in Patients With Bronchiectasis (NCT NCT00952718)
NCT ID: NCT00952718
Last Updated: 2021-07-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
baseline and 8 weeks
Results posted on
2021-07-28
Participant Flow
Participant milestones
| Measure |
Control
No intervention.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Inspiratory Muscle Training in Patients With Bronchiectasis
Baseline characteristics by cohort
| Measure |
Inspiratory Muscle Training
n=13 Participants
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.
|
Control
n=13 Participants
No intervention.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 10 • n=5 Participants
|
56 years
STANDARD_DEVIATION 9 • n=7 Participants
|
60 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 8 weeksMEP 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.
Outcome measures
| Measure |
Inspiratory Muscle Training
n=13 Participants
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.
|
Control
n=13 Participants
No intervention.
|
|---|---|---|
|
Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks
MIP baseline
|
60 cmH2O
Standard Deviation 21
|
71 cmH2O
Standard Deviation 16.4
|
|
Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks
MIP at 8 weeks
|
84 cmH2O
Standard Deviation 29
|
69 cmH2O
Standard Deviation 19
|
|
Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks
MEP at baseline
|
72 cmH2O
Standard Deviation 31
|
76 cmH2O
Standard Deviation 20
|
|
Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks
MEP at 8 weeks
|
104 cmH2O
Standard Deviation 35
|
88 cmH2O
Standard Deviation 24
|
SECONDARY outcome
Timeframe: baseline and 8 weeksThe 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.
Outcome measures
| Measure |
Inspiratory Muscle Training
n=13 Participants
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.
|
Control
n=13 Participants
No intervention.
|
|---|---|---|
|
Six Minutes Walking Distance
baseline
|
427 meter
Standard Deviation 125
|
411 meter
Standard Deviation 133
|
|
Six Minutes Walking Distance
8 weeks
|
447 meter
Standard Deviation 77
|
473 meter
Standard Deviation 117
|
SECONDARY outcome
Timeframe: baseline and 8 weeksThe 6-minute walk work (6Mwork) value was calculated as body mass distance covered during the 6-minute walking test.
Outcome measures
| Measure |
Inspiratory Muscle Training
n=13 Participants
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.
|
Control
n=13 Participants
No intervention.
|
|---|---|---|
|
6 Minute Work
baseline
|
20140 Kg*Meter
Standard Deviation 7813
|
21052 Kg*Meter
Standard Deviation 8286
|
|
6 Minute Work
8 weeks
|
22457 Kg*Meter
Standard Deviation 8596
|
23915 Kg*Meter
Standard Deviation 8343
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Inspiratory Muscle Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place