Inspiratory Muscle Training in Individuals With Cystic Fibrosis

Study Overview
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Brief Summary
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Cystic fibrosis is a genetic disease that affects some organs of the human body. Among them, the lungs tend to be the most affected due to the accumulation of mucus in the airways, which in addition to avoiding the passage of air, favors pulmonary infections. With the evolution of the condition, secondary complications arise, such as postural changes, decreased respiratory muscle strength, decreased functional capacity and, consequently, quality of life. Therefore, respiratory muscle training may be an intervention that improves the respiratory condition of these individuals, allowing an improvement in the quality of life and may delay the evolution of respiratory symptoms. Thus, this study aims to investigate a home protocol of respiratory muscle training on respiratory muscle strength, lung function, quality of life, posture and functional capacity in adolescents and adults with cystic fibrosis. The researchers believe that the training can cause an improvement in the studied variables, and can be inserted in the usual treatment of these patients.

Official Title
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Effects of Inspiratory Muscle Training in Individuals Who Have Cystic Fibrosis

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Device: Inspiratory muscle training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cystic fibrosis, confirmed by the sweat test; 14 - 25 years; Clinical stability; Absence of bacterial colonization for 4 weeks; Both sexes; Exclusion Criteria: Inability to perform the protocol established by the study; Present any intercurrence during data collection; Being unable to understand and / or perform procedures. Colonization during study participation; Patient hospitalization due to worsening of the clinical picture.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GExp<br>This group will perform the inspiratory muscle training with moderate load | Device: Inspiratory muscle training<br>* This group will initiate inspiratory muscle training with 40% of the MIP load and each week will have a load increase of 10% of the initial MIP up to 4 weeks of training<br>|
| Active Comparator: GCon<br>This group will initiate inspiratory muscle training with low load | Device: Inspiratory muscle training<br>* This group will initiate inspiratory muscle training with 40% of the MIP load and each week will have a load increase of 10% of the initial MIP up to 4 weeks of training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Posture at 4 weeks | Inclinometer Danoplus® | Baseline and after 4 weeks of training | 
| Change from baseline Health-related quality of life at 4 weeks | Health-related quality of life questionnaire (HRQoL) | Baseline and after 4 weeks of training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Respiratory muscle strength at 4 weeks | MVD300® | Baseline and after 4 weeks of training | 
| Change from baseline Pulmonary function at 4 weeks | Spirometry test using Koko® device | Baseline and after 4 weeks of training | 
| Change from baseline Functional capacity at 4 weeks | three-minute step test | Baseline and after 4 weeks of training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cystic fibrosis, quality of life, posture