Inspiratory Muscle Training and Asthma

Study Overview
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Brief Summary
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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.

Official Title
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Inspiratory Muscle Training as a Novel Approach in the Treatment of Asthma

Conditions
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Asthma

Intervention / Treatment
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* Other: inspiratory muscle training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asthma Control Questionnaire score of ≥ 1.5 10 mg or less of prednisolone (or equivalent) daily Aged 18 to 59 years inclusive Able to provide written informed consent Exclusion Criteria: Any significant heart or lung disease other than asthma including any previous history of pneumothorax Patients with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease) not controlled with treatment, making implementation of the protocol or interpretation of the study results difficult Women who are pregnant Forced expiratory volume in one second of less than 50% best or predicted A history of smoking 20 cigarettes a day for 20 years or more (or an equivalent amount) Undertaken a structured program of inspiratory muscle training within the past three months Currently a participant in another interventional study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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 | Other: inspiratory muscle training<br>* 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.<br>|
| Sham Comparator: Sham Comparator<br>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. | Other: inspiratory muscle training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, inspiratory muscle training