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

University of Portsmouth2 sites in 1 country16 target enrollmentFebruary 2014

ConditionsAsthma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Asthma
Sponsor: University of Portsmouth
Enrollment: 16
Locations: 2
Primary Endpoint: Maximal Inspiratory Mouth Pressure (MIP)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

May 2015

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Portsmouth

Responsible Party

Principal Investigator

Mitch Lomax

Senior Lecturer

University of Portsmouth

Eligibility Criteria

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

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).