An interventional study of Inspiratory Muscle Training with Powerbreath IMT device. in Amyotrophic Lateral Sclerosis, sponsored by Universidad Francisco de Vitoria. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2022-05-27.
Sponsored by Universidad Francisco de Vitoria · Not applicable, Interventional, and Supportive care
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.
1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.
This study's enrollment of 20 is below the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →Universidad Francisco de Vitoria is the lead sponsor of 52 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Treatment as usual
Other: Inspiratory Muscle Training with Powerbreath IMT device.
Without inspiratory muscle training. Treatment as usual.
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.
PImax
Maximum Inspiratory Pressure
Time frame: 8 weeks
HRV
Heart Rate Variability
Time frame: 8 weeks
HR
Heart Rate
Time frame: 8 weeks
ALSAQ-40
The Amyotrophic Lateral Sclerosis Assessment Questionnaire
Time frame: 8 weeks
ALSFRS-R
ALS Functional Rating Scale Revised
Time frame: 8 weeks
Beck scale
Depression scale
Time frame: 8 weeks
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad Francisco de Vitoria