Inspiratory Muscle Training With Powerbreath Device in Patients With ALS

May 25, 2022 updated by: Universidad Francisco de Vitoria

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Pozuelo De Alarcón, Madrid, Spain, 28223
        • Universidad Francisco de Vitoria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Treatment as usual
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.
NO_INTERVENTION: Control
Without inspiratory muscle training. Treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PImax
Time Frame: 8 weeks
Maximum Inspiratory Pressure
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HRV
Time Frame: 8 weeks
Heart Rate Variability
8 weeks
HR
Time Frame: 8 weeks
Heart Rate
8 weeks
ALSAQ-40
Time Frame: 8 weeks
The Amyotrophic Lateral Sclerosis Assessment Questionnaire
8 weeks
ALSFRS-R
Time Frame: 8 weeks
ALS Functional Rating Scale Revised
8 weeks
Beck scale
Time Frame: 8 weeks
Depression scale
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Francisco de Vitoria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 17, 2021

Primary Completion (ACTUAL)

September 12, 2021

Study Completion (ACTUAL)

November 12, 2021

Study Registration Dates

First Submitted

May 14, 2021

First Submitted That Met QC Criteria

May 14, 2021

First Posted (ACTUAL)

May 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALS_UFV_21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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