Effects of Inspiratory Muscle Training in Patients With Advanced Lung Disease

Study Overview
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Brief Summary
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The aim of this clinical trial is to evaluate, the effects of inspiratory muscle training program in inspiratory muscle function, functional capacity, quality of life, lung function, breathing pattern and chest wall motion in patients with advanced lung disease. Patients were evaluated before the inspiratory muscle training, after 8 weeks of training and at follow-up which was performed 3 months after the end of the intervention.

Detailed Description
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Inspiratory Muscle Training (IMT) should be considered an additional intervention in the pulmonary rehabilitation program for patients with advanced lung disease. The aim of this study is to evaluate, the effects of inspiratory muscle training program in inspiratory muscle function, functional capacity, quality of life, lung function, breathing pattern and chest wall motion in patients with advanced lung disease. It is a quasi-experimental study with longitudinal design. Patients with advanced lung disease from the advanced lung disease and pre lung transplantation ambulatory performed home-based high intensity interval IMT for 8 weeks (two sessions per day, daily). In each session patients executed two times 30 breaths with one-minute rest between them. Resistance was set to the highest tolerable according to scores pointed by the patient on the Borg score (between 4 and 6) aiming 50% of actual pimax or higher. An experienced physiotherapist was responsible for weekly adjustments on the resistance of training as well as new assessment of maximal inspiratory pressure. Patients were evaluated before the inspiratory muscle training, after 8 weeks of training and at follow-up which was performed 3 months after the end of the intervention. Patients were evaluated by the same experienced researcher in all three moments of the study. Evaluations were performed in the Laboratory of research and evaluation of cardiorespiratory performance of Federal University of Minas Gerais.

Official Title
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Effects of Inspiratory Muscle Training in Inspiratory Muscle Function, Functional Capacity, Quality of Life, Lung Function, Breathing Pattern and Thoracoabdominal Motion in Patients With Advanced Lung Disease

Conditions
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Lung Diseases, Pulmonary Disease

Intervention / Treatment
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* Other: Inspiratory Muscle Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of inspiratory muscle weakness (Maximal Inspiratory Pressure - MIP ≤ 60 cmH2O or below the reference values proposed for the Brazilian population. completion of a 36 sessions of PR or nonattendance in any pulmonary rehabilitation by the time of inclusion and no perspective of initiating it in the next 8 weeks. absence of pre-existing neuromuscular, infectious, metabolic, psychiatric diseases or orthopedic problems that prevent from activities of daily living. Exclusion Criteria: presented inspiratory muscle strength higher than 60 cmH2O or predicted value unable to follow commands related to the measurements or to the IMT

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Interventional Model Description: All patients from the advanced lung disease and pre lung transplantation ambulatory
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMT group<br>Group intervention: home-based interval inspiratory muscle training: during 8 weeks (two sessions per day, daily) two times 30 breaths with one-minute rest between them in each session training resistance set to the highest tolerable load according to scores pointed by the patient on the Borg score (between 4 and 6) aiming 50% of actual pimax or higher adjusted in the supervised weekly session | Other: Inspiratory Muscle Training<br>* Breathing through a device that offers resistance during inspiration. In this study the POWERbreathe device was used (POWERbreathe® K3, HaB International Ltd, UK).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Inspiratory muscle strength | Maximal inspiratory pressure in cmH2O | Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention) | 
| Change in Inspiratory Muscle Endurance | Inspiratory endurance time in seconds | Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lung Function | Spirometry | Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention) | 
| Change in Breathing pattern | Optoelectronic plethysmography (percentage of contribution of the 3 lung compartments to ventilation) | Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention) | 
| Change in chest wall motion | Optoelectronic plethysmography (lung volumes in liters) | Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention) | 
| Change in Functional Capacity (direct measure) | Six minutes walking distance (meters) | Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention) | 
| Change in Functional Capacity (inderect measure) | London chest activity of daily living scale (total score) - It evaluates the dyspnea in daily activities. Consists in a 15 questions questionnaire with scores from 0-5 in each question. Total score varies from 0 to 75, the higher the score the major the limitation on daily activities due to dyspnea. | Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention) | 
| Quality of life | Saint George Respiratory questionnaire (total score) It is a 50 questions questionnaire. Total score can go from 0 to 100. Higher scores indicate worse quality of life. | Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inspiratory muscle training, advanced lung disease, maximal inspiratory pressure, inspiratory endurance