Inspiratory Muscle Training With Powerbreath Device in Patients With ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04889248
• Other study ID #: ALS_UFV_21
• Status: Completed
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: November 12, 2021

Study information

• Verified date: May 2022
• Source: Universidad Francisco de Vitoria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 12, 2021
• Est. primary completion date: September 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Respiratory Aspiration
• Sclerosis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Universidad Francisco de Vitoria	Pozuelo De Alarcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Francisco de Vitoria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PImax	Maximum Inspiratory Pressure	8 weeks
Secondary	HRV	Heart Rate Variability	8 weeks
Secondary	HR	Heart Rate	8 weeks
Secondary	ALSAQ-40	The Amyotrophic Lateral Sclerosis Assessment Questionnaire	8 weeks
Secondary	ALSFRS-R	ALS Functional Rating Scale Revised	8 weeks
Secondary	Beck scale	Depression scale	8 weeks