Inspiratory Muscle Training With Powerbreath Device in Patients With ALS

Universidad Francisco de Vitoria

Status: Completed

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Other: Inspiratory Muscle Training with Powerbreath IMT device.

Study type: Interventional

Funder types: Other

Identifiers

NCT04889248

ALS_UFV_21

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Intervention

Experimental group

Description:

Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Treatment as usual

Treatment:

Other: Inspiratory Muscle Training with Powerbreath IMT device.

Control

No Intervention group

Description:

Without inspiratory muscle training. Treatment as usual.