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Inspiratory Muscle Training With Powerbreath Device in Patients With ALS

NCT04889248 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-05-27

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Universidad Francisco de Vitoria

    lead OTHER

Principal Investigators

  • Davinia Vicente Campos, PhD · Universidad Francisco de Vitoria

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2021-09-12
Completion
2021-11-12

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04889248 on ClinicalTrials.gov