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Completed

NCT Number: NCT04889248

Inspiratory Muscle Training With Powerbreath Device in Patients With ALS

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, 28223, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inspiratory Muscle Training with Powerbreath IMT device.

Other

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.

Primary outcomes

  1. PImax

    Time frame: 8 weeks

    Maximum Inspiratory Pressure

Secondary outcomes

  1. HRV

    Time frame: 8 weeks

    Heart Rate Variability

  2. HR

    Time frame: 8 weeks

    Heart Rate

  3. ALSAQ-40

    Time frame: 8 weeks

    The Amyotrophic Lateral Sclerosis Assessment Questionnaire

  4. ALSFRS-R

    Time frame: 8 weeks

    ALS Functional Rating Scale Revised

  5. Beck scale

    Time frame: 8 weeks

    Depression scale

Sponsors and collaborators

Lead sponsor

Universidad Francisco de Vitoria

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 17, 2021
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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