NCT04889248

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

May 17, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2021

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

May 14, 2021

Last Update Submit

May 25, 2022

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic lateral sclerosisMaximum Inspiratory PressureDiaphragm

Outcome Measures

Primary Outcomes (1)

  • PImax

    Maximum Inspiratory Pressure

    8 weeks

Secondary Outcomes (5)

  • HRV

    8 weeks

  • HR

    8 weeks

  • ALSAQ-40

    8 weeks

  • ALSFRS-R

    8 weeks

  • Beck scale

    8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Inspiratory Muscle Training with Powerbreath IMT device.

Control

NO INTERVENTION

Without inspiratory muscle training. Treatment as usual.

Interventions

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.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Subjects with ALS

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Davinia Vicente Campos, PhD

    Universidad Francisco de Vitoria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2021

First Posted

May 17, 2021

Study Start

May 17, 2021

Primary Completion

September 12, 2021

Study Completion

November 12, 2021

Last Updated

May 27, 2022

Record last verified: 2022-05

Locations

ES(1)