Inspiratory Muscle Training With Powerbreath Device in Patients With ALS
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Inspiratory Muscle Training with Powerbreath IMT device.
Sponsored by
About this trial
This is an interventional supportive care trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic lateral sclerosis, Maximum Inspiratory Pressure, Diaphragm
Eligibility Criteria
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.
Sites / Locations
- Universidad Francisco de Vitoria
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Treatment as usual
Without inspiratory muscle training. Treatment as usual.
Outcomes
Primary Outcome Measures
PImax
Maximum Inspiratory Pressure
Secondary Outcome Measures
HRV
Heart Rate Variability
HR
Heart Rate
ALSAQ-40
The Amyotrophic Lateral Sclerosis Assessment Questionnaire
ALSFRS-R
ALS Functional Rating Scale Revised
Beck scale
Depression scale
Full Information
NCT ID
NCT04889248
First Posted
May 14, 2021
Last Updated
May 25, 2022
Sponsor
Universidad Francisco de Vitoria
1. Study Identification
Unique Protocol Identification Number
NCT04889248
Brief Title
Inspiratory Muscle Training With Powerbreath Device in Patients With ALS
Official Title
Inspiratory Muscle Training in Respiratory Capacity, Heart Rate Variability, Life Quality and Emotional State in Patients With Amyotrophic Lateral Sclerosis.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
September 12, 2021 (Actual)
Study Completion Date
November 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Francisco de Vitoria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic lateral sclerosis, Maximum Inspiratory Pressure, Diaphragm
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Treatment as usual
Arm Title
Control
Arm Type
No Intervention
Arm Description
Without inspiratory muscle training. Treatment as usual.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training with Powerbreath IMT device.
Intervention Description
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 Outcome Measure Information:
Title
PImax
Description
Maximum Inspiratory Pressure
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
HRV
Description
Heart Rate Variability
Time Frame
8 weeks
Title
HR
Description
Heart Rate
Time Frame
8 weeks
Title
ALSAQ-40
Description
The Amyotrophic Lateral Sclerosis Assessment Questionnaire
Time Frame
8 weeks
Title
ALSFRS-R
Description
ALS Functional Rating Scale Revised
Time Frame
8 weeks
Title
Beck scale
Description
Depression scale
Time Frame
8 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davinia Vicente Campos, PhD
Organizational Affiliation
Universidad Francisco de Vitoria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Francisco de Vitoria
City
Pozuelo De Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
12. IPD Sharing Statement
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Inspiratory Muscle Training With Powerbreath Device in Patients With ALS
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