Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics
September 6, 2019 updated by: Gardenia Maria Holanda Ferreira, Universidade Federal do Rio Grande do Norte
Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics: a Randomized Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande Do Norte
-
Natal, Rio Grande Do Norte, Brazil, 59078-970
- Gardenia Maria Holanda Ferreira
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High-intensity IMT
Participants enrolled in this arm received high-intensity IMT
|
30 breaths at 50% of the maximal inspiratory pressure, twice daily for 6 weeks
|
|
Active Comparator: Low-intensity IMT
Participants enrolled in this arm received low-intensity IMT
|
30 breaths at 15% of the maximal inspiratory pressure, twice daily for 6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in inspiratory muscle strength
Time Frame: Baseline, 6 weeks later and 6 weeks after training
|
Maximal inspiratory pressure
|
Baseline, 6 weeks later and 6 weeks after training
|
|
Change in expiratory muscle strength
Time Frame: Baseline, 6 weeks later and 6 weeks after training
|
Maximal expiratory pressure
|
Baseline, 6 weeks later and 6 weeks after training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in asthma control
Time Frame: Baseline, 6 weeks later and 6 weeks after training
|
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)
|
Baseline, 6 weeks later and 6 weeks after training
|
|
Change in quality of life
Time Frame: Baseline, 6 weeks later and 6 weeks after training
|
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.
|
Baseline, 6 weeks later and 6 weeks after training
|
|
Change in six minute walk test distance
Time Frame: Baseline, 6 weeks later and 6 weeks after training
|
Six-minute walk test (6MWT)
|
Baseline, 6 weeks later and 6 weeks after training
|
|
Change in forced vital capacity
Time Frame: Baseline, 6 weeks later and 6 weeks after training
|
Forced vital capacity in litres and % of predicted
|
Baseline, 6 weeks later and 6 weeks after training
|
|
Change in forced expiratory volume
Time Frame: Baseline, 6 weeks later and 6 weeks after training
|
Forced expiratory volume in litres and % of predicted
|
Baseline, 6 weeks later and 6 weeks after training
|
|
Change in forced expiratory volume/forced vital capacity
Time Frame: Baseline, 6 weeks later and 6 weeks after training
|
Forced expiratory volume/forced vital capacity
|
Baseline, 6 weeks later and 6 weeks after training
|
|
Change in inspiratory muscle activity
Time Frame: Baseline, 6 weeks later and 6 weeks after training
|
Surface electromyography of inspiratory muscles
|
Baseline, 6 weeks later and 6 weeks after training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2016
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
September 25, 2016
First Submitted That Met QC Criteria
September 26, 2016
First Posted (Estimate)
September 28, 2016
Study Record Updates
Last Update Posted (Actual)
September 10, 2019
Last Update Submitted That Met QC Criteria
September 6, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.533.228
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.