Inspiratory Muscle Training as a Novel Approach in the Treatment of Asthma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Portsmouth
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Maximal Inspiratory Mouth Pressure (MIP)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 59 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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
Intervention: inspiratory muscle training (Other)
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.
Intervention: inspiratory muscle training (Other)
Outcomes
Primary Outcomes
Maximal Inspiratory Mouth Pressure (MIP)
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Mitch Lomax
Senior Lecturer
University of Portsmouth