Inspiratory Muscle Training With Powerbreath Device in Patients With ALS

Not Applicable

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Other: Inspiratory Muscle Training with Powerbreath IMT device.

• Registration Number: NCT04889248
• Lead Sponsor: Universidad Francisco de Vitoria

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-14
• Study First Submitted QC: 2021-05-14
• Study Start: 2021-05-17
• Study First Posted: 2021-05-17
• Primary Completion: 2021-09-12
• Study Completion: 2021-11-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Inspiratory Muscle Training with Powerbreath IMT device.	Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Treatment as usual

Primary Outcome Measures

Name	Time	Method
PImax	8 weeks	Maximum Inspiratory Pressure

Secondary Outcome Measures

Name	Time	Method
HR	8 weeks	Heart Rate
ALSFRS-R	8 weeks	ALS Functional Rating Scale Revised
HRV	8 weeks	Heart Rate Variability
ALSAQ-40	8 weeks	The Amyotrophic Lateral Sclerosis Assessment Questionnaire
Beck scale	8 weeks	Depression scale

Trial Locations

Locations (1)

Universidad Francisco de Vitoria; 🇪🇸 Pozuelo De Alarcón, Madrid, Spain