Impact of Inspiratory Muscle Training on Daily Physical Activity (INAF)

Study Overview
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Brief Summary
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The impact of the reduction of daily physical activity (DPA) in patients with COPD (chronic obstructive pulmonary disease) is a highly studied area, due to its impact on the quality of life and the clinical evolution of the disease . This fact has multifactorial components: its function is naturally diminished with time, and its effects on the loss of physical condition (decondition). However, dynamic hyperinflation and respiratory muscular dysfunction, especially in patients with more symptomatology, have been identified as those that have the most relevant factors that impact on daily physical activity Due to the detrimental effects of the pulmonary hyperinflation, the diaphragm is flatter and shorter, being in a position of mechanical disadvantage. This contributes to a reduced effort capacity and increase in the dyspnea of patients during daily activities. Resistance training improves their exercise capacity and reduces dyspnea, however it does not improve inspiratory muscle strength. It is for this reason, that specific training of the inspiratory muscles, offers special interest in patients with decreased inspiratory muscle strength and pulmonary hyperinflation.

Official Title
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Impact of Inspiratory Muscle Training on Daily Physical Activity (INAF)

Conditions
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Inspiratory Muscle Training

Intervention / Treatment
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* Device: ORYGEN DUAL Sham Valve
* Device: ORYGEN DUAL Valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible for the respiratory rehabilitation programme participants must have stable COPD (at least 4 weeks), inspiratory muscle weakness (PImax <70%) and pulmonary hyperinflation (TLC > 120%). Patient that have signed inform consent. Exclusion Criteria: Hospitalization within the previous 14 days Current participation in rehabilitation program, Locomotor or neurological condition or disability limiting the ability to perform exercise, Lung transplantation or lung volume reduction surgery foreseen within 1 month after discharge.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham valve (Placebo)<br>Sham Inspiratory valve (without resistance) | Device: ORYGEN DUAL Sham Valve<br>* Training of the inspiratory muscles during 5 weeks<br>|
| Experimental: Intervention<br>Inspiratory valve with increase resistance | Device: ORYGEN DUAL Valve<br>* Training of the inspiratory muscles during 5 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of daily physical activity | Change From Baseline at least 10% moderate to vigorous daily physical activity measured by accelerometer | Baseline and 5 weeks |