Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04889248
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2021-05-14
Brief Title:
Inspiratory Muscle Training With Powerbreath Device in Patients With ALS
Sponsor:
Universidad Francisco de Vitoria
Organization:
Universidad Francisco de Vitoria
Study Overview
Official Title:
Inspiratory Muscle Training in Respiratory Capacity Heart Rate Variability Life Quality and Emotional State in Patients With Amyotrophic Lateral Sclerosis
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Abstract
Contextbackground 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
Contextbackground 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None