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Inspiratory Muscle Training and Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
inspiratory muscle training
Sponsored by
University of Portsmouth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, inspiratory muscle training

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Respiratory Centre, Queen Alexandra Hospital, Cosham
  • University of Portsmouth

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental

Sham Comparator

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
November 7, 2012
Last Updated
October 2, 2019
Sponsor
University of Portsmouth
Collaborators
National Health Service, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT01727765
Brief Title
Inspiratory Muscle Training and Asthma
Official Title
Inspiratory Muscle Training as a Novel Approach in the Treatment of Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Portsmouth
Collaborators
National Health Service, United Kingdom

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, inspiratory muscle training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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
Arm Title
Sham Comparator
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
inspiratory muscle training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximal Inspiratory Mouth Pressure (MIP)
Description
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).
Time Frame
pre (after the 4 week run-in) and post 6 weeks of IMT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Respiratory Centre, Queen Alexandra Hospital, Cosham
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
University of Portsmouth
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
PO6 3LY
Country
United Kingdom

12. IPD Sharing Statement

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Inspiratory Muscle Training and Asthma

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