Inspiratory Muscle Training and Asthma

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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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Respiratory Centre, Queen Alexandra Hospital, Cosham, Portsmouth, Hampshire, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Sponsors and collaborators

Lead sponsor

University of Portsmouth

Other

Collaborators

National Health Service, United Kingdom

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Nov 16, 2012
Registry last updated: Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed