Inspiratory Muscle Training and Asthma

NCT ID: NCT01727765

Last Updated: 2019-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-05-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

inspiratory muscle training

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

inspiratory muscle training

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Health Service, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

University of Portsmouth

OTHER

Sponsor Role: lead

Responsible Party

Mitch Lomax

Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Respiratory Centre, Queen Alexandra Hospital, Cosham

Portsmouth, Hampshire, United Kingdom

University of Portsmouth

Portsmouth, Hampshire, United Kingdom

Countries

United Kingdom

Other Identifiers

IMT and Asthma

Identifier Type: -

Identifier Source: org_study_id