Inspiratory Muscle Training and Asthma

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Portsmouth
Sponsor:
Collaborator:
National Health Service, United Kingdom
Information provided by (Responsible Party):
Mitch Lomax, University of Portsmouth
ClinicalTrials.gov Identifier:
NCT01727765
First received: November 7, 2012
Last updated: February 12, 2014
Last verified: February 2014
  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:


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: February 2014
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (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 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
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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
Respiratory Centre, Queen Alexandra Hospital, Cosham Recruiting
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Contact: Anoop Chauhan    +440232286000    anoop.chauahn@porthosp.nhs.uk   
Contact: Olivia Scullion-Winn    +440232286000    olivia.scullionwinn@porthosp.nhs.uk   
Principal Investigator: Anoop Chauhan         
University of Portsmouth 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   
Principal Investigator: Mitch Lomax         
Sub-Investigator: Janis Shute         
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: February 12, 2014
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
Pathologic Processes
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014