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Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
High-intensity IMT
Low-intensity IMT
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of asthma
  • Adults (18 - 60 years)

Exclusion Criteria:

  • Inability to perform the protocol established by the study
  • Others respiratory diseases
  • Request for study withdrawal

Sites / Locations

  • Gardenia Maria Holanda Ferreira

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-intensity IMT

Low-intensity IMT

Arm Description

Participants enrolled in this arm received high-intensity IMT

Participants enrolled in this arm received low-intensity IMT

Outcomes

Primary Outcome Measures

Change in inspiratory muscle strength
Maximal inspiratory pressure
Change in expiratory muscle strength
Maximal expiratory pressure

Secondary Outcome Measures

Change in asthma control
Asthma Control Questionnaire measures the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. Scores range between 0 (totally controlled) and 6 (severely uncontrolled)
Change in quality of life
Asthma Quality of Life Questionnaire is a disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease. Scores range 1-7, with higher scores indicating better quality of life.
Change in six minute walk test distance
Six-minute walk test (6MWT)
Change in forced vital capacity
Forced vital capacity in litres and % of predicted
Change in forced expiratory volume
Forced expiratory volume in litres and % of predicted
Change in forced expiratory volume/forced vital capacity
Forced expiratory volume/forced vital capacity
Change in inspiratory muscle activity
Surface electromyography of inspiratory muscles

Full Information

First Posted
September 25, 2016
Last Updated
September 6, 2019
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT02917824
Brief Title
Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics
Official Title
Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Inspiratory muscle training (IMT) can reverse or delay the complications from the deterioration of inspiratory muscle function in asthma. Thus, the IMT has been considered a treatment option for people with asthma. The aim of this study is to investigate the training principles of intensity, specificity and reversibility of IMT in asthmatics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity IMT
Arm Type
Experimental
Arm Description
Participants enrolled in this arm received high-intensity IMT
Arm Title
Low-intensity IMT
Arm Type
Active Comparator
Arm Description
Participants enrolled in this arm received low-intensity IMT
Intervention Type
Device
Intervention Name(s)
High-intensity IMT
Intervention Description
30 breaths at 50% of the maximal inspiratory pressure, twice daily for 6 weeks
Intervention Type
Device
Intervention Name(s)
Low-intensity IMT
Intervention Description
30 breaths at 15% of the maximal inspiratory pressure, twice daily for 6 weeks
Primary Outcome Measure Information:
Title
Change in inspiratory muscle strength
Description
Maximal inspiratory pressure
Time Frame
Baseline, 6 weeks later and 6 weeks after training
Title
Change in expiratory muscle strength
Description
Maximal expiratory pressure
Time Frame
Baseline, 6 weeks later and 6 weeks after training
Secondary Outcome Measure Information:
Title
Change in asthma control
Description
Asthma Control Questionnaire measures the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. Scores range between 0 (totally controlled) and 6 (severely uncontrolled)
Time Frame
Baseline, 6 weeks later and 6 weeks after training
Title
Change in quality of life
Description
Asthma Quality of Life Questionnaire is a disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease. Scores range 1-7, with higher scores indicating better quality of life.
Time Frame
Baseline, 6 weeks later and 6 weeks after training
Title
Change in six minute walk test distance
Description
Six-minute walk test (6MWT)
Time Frame
Baseline, 6 weeks later and 6 weeks after training
Title
Change in forced vital capacity
Description
Forced vital capacity in litres and % of predicted
Time Frame
Baseline, 6 weeks later and 6 weeks after training
Title
Change in forced expiratory volume
Description
Forced expiratory volume in litres and % of predicted
Time Frame
Baseline, 6 weeks later and 6 weeks after training
Title
Change in forced expiratory volume/forced vital capacity
Description
Forced expiratory volume/forced vital capacity
Time Frame
Baseline, 6 weeks later and 6 weeks after training
Title
Change in inspiratory muscle activity
Description
Surface electromyography of inspiratory muscles
Time Frame
Baseline, 6 weeks later and 6 weeks after training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of asthma Adults (18 - 60 years) Exclusion Criteria: Inability to perform the protocol established by the study Others respiratory diseases Request for study withdrawal
Facility Information:
Facility Name
Gardenia Maria Holanda Ferreira
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59078-970
Country
Brazil

12. IPD Sharing Statement

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Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics

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