Inspiratory Muscle Training and Asthma - Full Text View

Purpose

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.

Condition	Intervention
Asthma	Other: inspiratory muscle training

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Inspiratory Muscle Training as a Novel Approach in the Treatment of Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by University of Portsmouth:

Primary Outcome Measures:

Assess the feasibility of the methods adopted [ Time Frame: This will depend on when ethical approval is received. Participants will be actively engaged for 11 or 12 weeks ] [ Designated as safety issue: No ]
Two weeks at the start of the study (post informed consent) will be required for diary completion (asthma control diary; Asthma Quality of Life Questionnaire with Standardised Activities).

One week for pre-intervention testing (body plethysmography, exhaled nitric oxide, blood immunoglobulin G, respiratory muscle strength).

Six weeks of inspiratory muscle training (details provided elsewhere).

One week for post-intervention testing (plethysmography, exhaled nitric oxide, blood immunoglobulin G, respiratory muscle strength).

Two weeks will be required towards the end of inspiratory muscle training for diary completion (asthma control diary; Asthma Quality of Life Questionnaire with Standardised Activities). This two week period will coincide with the final week of inspiratory muscle training and the first week following it.

Estimated Enrollment:	20
Study Start Date:	January 2013
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Experimental 6 weeks of inspiratory muscle training, 6 days per week. The intensity of training will be equivalent 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 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: 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 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.

Arms

Assigned Interventions

Experimental: Experimental

6 weeks of inspiratory muscle training, 6 days per week. The intensity of training will be equivalent 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

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: 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

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.

Eligibility

Ages Eligible for Study:	18 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed as having partly controlled or uncontrolled asthma according to the Global Initiative for Asthma guidelines
Aged 18 to 59 years.

Exclusion Criteria:

Current smoker.
Well controlled asthma.
Undertaken a structured program of inspiratory muscle training within the past three months.
Participating in another study that is not solely observational.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727765

Locations

United Kingdom
Respiratory Centre, Queen Alexandra Hospital, Cosham	Not yet recruiting
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Contact: Dominic Reynish +440232286000 dominic.reynish@porthosp.nhs.uk
Contact: Sumita Kerley +440232286000 sumita.kerley2@porthosp.nhs.uk
Principal Investigator: Dominic Reynish
University of Portsmouth	Not yet recruiting
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Contact: Mitch Lomax +4402392845297 mitch.lomax@port.ac.uk
Contact: Janis Shute +4402392842152 jan.shute@port.ac.uk

Sponsors and Collaborators

University of Portsmouth

National Health Service, United Kingdom

More Information

No publications provided

Responsible Party:	Mitch Lomax, Senior Lecturer, University of Portsmouth
ClinicalTrials.gov Identifier:	NCT01727765 History of Changes
Other Study ID Numbers:	IMT and Asthma
Study First Received:	November 7, 2012
Last Updated:	November 12, 2012
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by University of Portsmouth:

Asthma, inspiratory muscle training

Additional relevant MeSH terms:

Respiratory Aspiration
Asthma
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases

Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013