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

Study Purpose:

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.

Study Status:

Not recruiting

Disease:

Amyotrophic Lateral Sclerosis

Study Type:

Interventional

Type of Intervention:

N/A

Intervention Name:

Inspiratory Muscle Training with Powerbreath IMT device.

Placebo:

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

Davinia Vicente Campos, PhD, Universidad Francisco de Vitoria

Clinicaltrials.gov ID:

NCT04889248

Neals Affiliated?

No

Coordinating Center Contact Information

Study Sponsor:

Universidad Francisco de Vitoria

Estimated Enrollment:

20

Estimated Study Start Date:

05 / 17 / 2021

Estimated Study Completion Date:

11 / 12 / 2021

Posting Last Modified Date:

05 / 27 / 2022

Date Study Added to neals.org:

05 / 17 / 2021

Minimum Age:

N/A

Maximum Age:

N/A

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.

Universidad Francisco de Vitoria

Pozuelo De Alarc├│n, Madrid 28223
Spain