Inspiratory Muscle Training and Asthma

NCT01727765 | Completed Results

• 1 other identifier: IMT and Asthma
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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

Keywords

Asthma, inspiratory muscle training

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental

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

Other: inspiratory muscle training

Sham Comparator

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.

Other: inspiratory muscle training

Interventions

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.

Experimental; Sham Comparator

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Asthma Control Questionnaire score of ≥ 1.5
• mg or less of prednisolone (or equivalent) daily
• Aged 18 to 59 years inclusive
• Able to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Portsmouth: lead
• National Health Service, United Kingdom: collaborator

Study Sites (2)

Respiratory Centre, Queen Alexandra Hospital, Cosham

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

University of Portsmouth

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Mitch Lomax
• Organization: University of Portsmouth

mitch.lomax@port.ac.uk

02392845297

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 16, 2012
• Study Start: February 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 25, 2019
• Results First Posted: October 25, 2019

Record last verified: 2019-10

Locations

GB (2)