Inspiratory Muscle Training With Powerbreath Device in Patients With ALS

Study Overview
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Brief Summary
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Abstract: Context/background: people affected by Amyotrophic Lateral Sclerosis (ALS) see their own life totally disturbed after the diagnosis. This disease also courses, apart from the functional and depressing worsening, with internal damage manifested by a cardio respiratory deterioration. There are not many clinical studies publications about this disease given that is considered a weird illness with short prognosis. Objectives: to examine the effects of the inspiratory muscle training (IMT) on respiratory muscle strength, heart rate variability (HRV), quality of life and mood in patients with ALS. Methods: 20 volunteer patients, male and female, with ALS, bulbar or spinal will take part of the cuasi-experimental study and they will be divided into two groups: an experimental group (n = 10) and a control group (n = 10). The Maximum Inspiratory Pressure (PIM), the HRV, the quality of life and mood will be measured. The participants of experimental group will conduct 30 inspirations per day, 15 in the morning and 15 in the evening, 5 days per week, through 8 weeks. The resistance of the training in the experimental group will be increase acording to the PIM measured at the first visit. During the first week, the resistance will be at 30% of PImax, weeks 2 and 3 at 40%, weeks 4 and 5 at 50% and the last 3 weeks at 60%. After 8 weeks, all participants will fill up again all scales and post training measurements will be taken.

Official Title
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Inspiratory Muscle Training in Respiratory Capacity, Heart Rate Variability, Life Quality and Emotional State in Patients With Amyotrophic Lateral Sclerosis.

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Other: Inspiratory Muscle Training with Powerbreath IMT device.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Subjects with ALS Exclusion Criteria: PImax more than 30mmH2O Score higher than 2 in GDS Reisberg scale Using already respiratory devices during the day (except night CPAPs support) more than 14h/day. Unstable medical disease for the last 3 years. Use of IMT contraindicated for medical reasons.
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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Treatment as usual | Other: Inspiratory Muscle Training with Powerbreath IMT device.<br>* Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Each day, each subject perform 15 repetitions in the morning and evening, from Monday to Friday, resting on weekends. The endurance of the device increases along the study, initiating with the 30% of their own maximum inspiratory pressure (PImax) during the first week and increasing a 10% every other week, till reach the goal of 60% PImax.<br>|
| No Intervention: Control<br>Without inspiratory muscle training. Treatment as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PImax | Maximum Inspiratory Pressure | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HRV | Heart Rate Variability | 8 weeks | 
| HR | Heart Rate | 8 weeks | 
| ALSAQ-40 | The Amyotrophic Lateral Sclerosis Assessment Questionnaire | 8 weeks | 
| ALSFRS-R | ALS Functional Rating Scale Revised | 8 weeks | 
| Beck scale | Depression scale | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amyotrophic lateral sclerosis, Maximum Inspiratory Pressure, Diaphragm