Inspiratory Muscle Training With Powerbreath Device in Patients With ALS
NCT ID: NCT04889248
Last Updated: 2022-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2021-05-17
2021-11-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention
Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Treatment as usual
Inspiratory Muscle Training with Powerbreath IMT device.
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.
Control
Without inspiratory muscle training. Treatment as usual.
No interventions assigned to this group
Interventions
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Inspiratory Muscle Training with Powerbreath IMT device.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
ALL
No
Sponsors
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Universidad Francisco de Vitoria
OTHER
Responsible Party
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Principal Investigators
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Davinia Vicente Campos, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad Francisco de Vitoria
Locations
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Universidad Francisco de Vitoria
Pozuelo de Alarcón, Madrid, Spain
Countries
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Other Identifiers
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ALS_UFV_21
Identifier Type: -
Identifier Source: org_study_id
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