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| Name | Class |
|---|---|
| National Health Service, United Kingdom | OTHER_GOV |
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This is a pilot study which will assess the feasibility of a follow on main study. This study will examine the impact of inspiratory muscle training on quality of life, rescue drug medication usage, and other markers of asthma in adult asthmatics in the UK.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | 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 |
|
| Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inspiratory muscle training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Inspiratory Mouth Pressure (MIP) | 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). | pre (after the 4 week run-in) and post 6 weeks of IMT |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory Centre, Queen Alexandra Hospital, Cosham | Portsmouth | Hampshire | PO6 3LY | United Kingdom | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximal Inspiratory Mouth Pressure (MIP) | 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). | As this was a feasibility study, statistical analysis was not required | Posted | Mean | Standard Deviation | kPa | pre (after the 4 week run-in) and post 6 weeks of IMT |
|
12 weeks. This encompassed the 4 week run-in period, 2 weeks for testing (one week pre IMT and 1 week post IMT) and 6 weeks for IMT.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Mitch Lomax | University of Portsmouth | 02392845297 | mitch.lomax@port.ac.uk |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
| University of Portsmouth |
| Portsmouth |
| Hampshire |
| PO6 3LY |
| United Kingdom |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | 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. | 0 | 8 | 0 | 8 | 0 | 8 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |