Inspiratory Muscle Training With Powerbreath Device in Patients With ALS

Sponsor

Universidad Francisco de Vitoria (Other)

Overall Status

Completed

CT.gov ID

NCT04889248

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Amyotrophic Lateral Sclerosis	Other: Inspiratory Muscle Training with Powerbreath IMT device.	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 17, 2021

Actual Primary Completion Date :

Sep 12, 2021

Actual Study Completion Date :

Nov 12, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

PImax [8 weeks]
Maximum Inspiratory Pressure

Secondary Outcome Measures

HRV [8 weeks]
Heart Rate Variability
HR [8 weeks]
Heart Rate
ALSAQ-40 [8 weeks]
The Amyotrophic Lateral Sclerosis Assessment Questionnaire
ALSFRS-R [8 weeks]
ALS Functional Rating Scale Revised
Beck scale [8 weeks]
Depression scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.