Trial Outcomes & Findings for Inspiratory Muscle Training and Asthma (NCT NCT01727765)
NCT ID: NCT01727765
Last Updated: 2019-10-25
Results Overview
MIP is a surrogate measure of inspiratory muscle strength and was measured pre and post 6 weeks of either experimental or sham inspiratory muscle trianing (IMT).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
pre (after the 4 week run-in) and post 6 weeks of IMT
Results posted on
2019-10-25
Participant Flow
Participant milestones
| Measure |
Experimental
6 weeks of inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to up to 50% of pre-training maximal inspiratory mouth pressure and will be adapted weekly to reflect the improvement in inspiratory muscle strength
inspiratory muscle training: Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H\&B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure.
|
Sham Comparator
6 weeks of sham inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to 5% of pre-training inspiratory mouth pressure throughout the 6 week period.
inspiratory muscle training: Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H\&B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inspiratory Muscle Training and Asthma
Baseline characteristics by cohort
| Measure |
Experimental
n=8 Participants
6 weeks of inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to up to 50% of pre-training maximal inspiratory mouth pressure and will be adapted weekly to reflect the improvement in inspiratory muscle strength
inspiratory muscle training: Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H\&B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure.
|
Sham Comparator
n=8 Participants
6 weeks of sham inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to 5% of pre-training inspiratory mouth pressure throughout the 6 week period.
inspiratory muscle training: Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H\&B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 12 • n=93 Participants
|
54 years
STANDARD_DEVIATION 14 • n=4 Participants
|
54 years
STANDARD_DEVIATION 12 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=93 Participants
|
8 participants
n=4 Participants
|
16 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: pre (after the 4 week run-in) and post 6 weeks of IMTPopulation: As this was a feasibility study, statistical analysis was not required
MIP is a surrogate measure of inspiratory muscle strength and was measured pre and post 6 weeks of either experimental or sham inspiratory muscle trianing (IMT).
Outcome measures
| Measure |
Experimental
n=8 Participants
Undertook 6 weeks of real IMT
|
Sham
n=8 Participants
undertook 6 weeks of sham IMT
|
|---|---|---|
|
Maximal Inspiratory Mouth Pressure (MIP)
MIP pre training
|
9.36 kPa
Standard Deviation 2.63
|
9.37 kPa
Standard Deviation 2.90
|
|
Maximal Inspiratory Mouth Pressure (MIP)
MIP post training
|
10.55 kPa
Standard Deviation 2.72
|
9.21 kPa
Standard Deviation 2.66
|
Adverse Events
Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Comparator
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