Inspiratory Muscle Training and Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727765
• Other study ID #: IMT and Asthma
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: May 2015

Study information

• Verified date: October 2019
• Source: University of Portsmouth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Respiratory Aspiration

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	Respiratory Centre, Queen Alexandra Hospital, Cosham	Portsmouth	Hampshire
United Kingdom	University of Portsmouth	Portsmouth	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Portsmouth	National Health Service, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	pre (after the 4 week run-in) and post 6 weeks of IMT