Asthma
Conditions
Keywords
Asthma, inspiratory muscle training
Brief summary
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.
Interventions
OTHERinspiratory 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.
Sponsors
National Health Service, United Kingdom
University of Portsmouth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Inspiratory Mouth Pressure (MIP) | pre (after the 4 week run-in) and post 6 weeks of IMT | 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). |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| 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. | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Sham Comparator | Experimental | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 7 Participants | 12 Participants |
| Age, Continuous | 54 years STANDARD_DEVIATION 14 | 53 years STANDARD_DEVIATION 12 | 54 years STANDARD_DEVIATION 12 |
| Region of Enrollment United Kingdom | 8 participants | 8 participants | 16 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
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).
Time frame: pre (after the 4 week run-in) and post 6 weeks of IMT
Population: As this was a feasibility study, statistical analysis was not required
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Maximal Inspiratory Mouth Pressure (MIP) | MIP pre training | 9.36 kPa | Standard Deviation 2.63 |
| Experimental | Maximal Inspiratory Mouth Pressure (MIP) | MIP post training | 10.55 kPa | Standard Deviation 2.72 |
| Sham | Maximal Inspiratory Mouth Pressure (MIP) | MIP pre training | 9.37 kPa | Standard Deviation 2.9 |
| Sham | Maximal Inspiratory Mouth Pressure (MIP) | MIP post training | 9.21 kPa | Standard Deviation 2.66 |