Respiratory Muscle Training in Acquired Brain Injury Patients.
Primary Purpose
Respiratory Disease, Muscle Weakness, Acquired Brain Injury
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inspiratory muscle training
Expiratory muscle training
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Disease
Eligibility Criteria
Inclusion Criteria: Belong to ASDACE. Sign the Informed consent. Exclusion Criteria: The presence of a respiratory disease in the previous month, inability to understand assessment tests or intervention or hemodynamic alterations (heart rate > 150 beats per minute (bpm), systolic blood pressure > 140 millimeters mercury (mmHg) or diastolic blood pressure > 90 mmHg).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Inspiratory muscle training group (IMT)
Expiratory muscle training group (EMT)
Arm Description
Inspiratory muscle training at 50% of MIP, the training load was set each 2 weeks to keep 50% of MIP.
Expiratory muscle training at 50% of MEP, following the same rules as HIT.
Outcomes
Primary Outcome Measures
Inspiratory muscle strength
It was measured using the maximum inspiratory pressure (MIP) with a pressure measurer (Elka PM-15, Laboliser, S.A., Barcelona, Spain), from residual volume and total lung capacity. Unit of measure, centimeter of water (cmH2O).
Expiratory muscle strength
It was measured using the maximum expiratory pressure (MEP) with a pressure measurer (Elka PM-15, Laboliser, S.A., Barcelona, Spain), from residual volume and total lung capacity. Unit of measure, centimeter of water (cmH2O).
Secondary Outcome Measures
Pulmonary volume.
Forced expiratory volume in 1 second (FEV1). It was measured using the peak flow device (Asma-1, Vitalograph Ltd, Buckingham, England). Unit of measure, liters (L).
Pulmonary flow.
Peak expiratory flow (PEF). It was measured using the peak flow device (Asma-1, Vitalograph Ltd, Buckingham, England). Unit of measure, liters per minute (L/min).
Full Information
NCT ID
NCT06070831
First Posted
September 23, 2023
Last Updated
September 30, 2023
Sponsor
University of Salamanca
1. Study Identification
Unique Protocol Identification Number
NCT06070831
Brief Title
Respiratory Muscle Training in Acquired Brain Injury Patients.
Official Title
Comparison Between Two Respiratory Muscle Training Protocols: Inspiratory Muscle Training vs Expiratory Muscle Training in Acquired Brain Injury Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 21, 2023 (Anticipated)
Primary Completion Date
February 21, 2024 (Anticipated)
Study Completion Date
April 21, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: Respiratory health problems are one of the main causes of morbidity and mortality in adult people with acquired brain injury (ABI). The influence of respiratory muscle training has not yet been studied in this population group. The objective of the study was to evaluate and compare the efficacy of two protocols with respiratory muscle training, inspiratory muscle training vs expiratory muscle training, to improve respiratory strength and pulmonary function in adults with CP.
Methods: The study is a controlled, randomised, double-blind trial and with allocation concealment. 26 ABI patients will be recruited and randomly distributed in the inspiratory muscle training group (IMT) and the expiratory muscle training group (EMT). Over an 8-week period an IMT or EMT protocol was followed 5 days/week, 5 series of 1-minute with 1-minute rest between them. IMT trained with a load of 50% of the maximum inspiratory pressure (MIP) and EMT with 50% of the maximum expiratory pressure (MEP). Respiratory strength and pulmonary function were evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disease, Muscle Weakness, Acquired Brain Injury, Older People--Abuse of, Physical Inactivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
The professional that collected the data and the participants were unaware of group assignment.
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Inspiratory muscle training group (IMT)
Arm Type
Experimental
Arm Description
Inspiratory muscle training at 50% of MIP, the training load was set each 2 weeks to keep 50% of MIP.
Arm Title
Expiratory muscle training group (EMT)
Arm Type
Experimental
Arm Description
Expiratory muscle training at 50% of MEP, following the same rules as HIT.
Intervention Type
Device
Intervention Name(s)
Inspiratory muscle training
Intervention Description
Respiratory training, performed through IMT, was carried out with a pressure threshold device (Treshold IMT, Philips-Respironics, Pittsburg, PA, USA). Threshold IMT offers a constant and specific pressure for strength and endurance training of the respiratory muscles, regardless of the strength or speed with which patient breathes. A flow-independent one-way valve ensures constant resistance and allows you to specifically adjust workload (in cmH2O). The training must be supervised by a healthcare professional. During the inspiration, a spring-loaded valve resists to stimulate the training of the respiratory muscles. Before training began, the participants and primary caregivers completed one-session familiarization with a specialist to know the operation of the device.
Adult people with acquired brain injury carried out the training program for 8 weeks, 1 session every day, 5 days a week. The participants performed 5 series of 1 minute with 1-minute rest between them.
Intervention Type
Device
Intervention Name(s)
Expiratory muscle training
Intervention Description
Respiratory training, performed through PEP, was carried out with a pressure threshold device (Treshold PEP, Philips-Respironics, Pittsburg, PA, USA). Threshold PEP offers a constant and specific pressure for strength and endurance training of the respiratory muscles, regardless of the strength or speed with which patient breathes. A flow-independent one-way valve ensures constant resistance and allows you to specifically adjust workload (in cmH2O). The training must be supervised by a healthcare professional. During the expiration, a spring-loaded valve resists to stimulate the training of the respiratory muscles. Before training began, the participants and primary caregivers completed one-session familiarization with a specialist to know the operation of the device.
Adult people with acquired brain injury carried out the training program for 8 weeks, 1 session every day, 5 days a week. The participants performed 5 series of 1 minute with 1-minute rest between them.
Primary Outcome Measure Information:
Title
Inspiratory muscle strength
Description
It was measured using the maximum inspiratory pressure (MIP) with a pressure measurer (Elka PM-15, Laboliser, S.A., Barcelona, Spain), from residual volume and total lung capacity. Unit of measure, centimeter of water (cmH2O).
Time Frame
8 weeks.
Title
Expiratory muscle strength
Description
It was measured using the maximum expiratory pressure (MEP) with a pressure measurer (Elka PM-15, Laboliser, S.A., Barcelona, Spain), from residual volume and total lung capacity. Unit of measure, centimeter of water (cmH2O).
Time Frame
8 weeks.
Secondary Outcome Measure Information:
Title
Pulmonary volume.
Description
Forced expiratory volume in 1 second (FEV1). It was measured using the peak flow device (Asma-1, Vitalograph Ltd, Buckingham, England). Unit of measure, liters (L).
Time Frame
8 weeks.
Title
Pulmonary flow.
Description
Peak expiratory flow (PEF). It was measured using the peak flow device (Asma-1, Vitalograph Ltd, Buckingham, England). Unit of measure, liters per minute (L/min).
Time Frame
8 weeks.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Belong to ASDACE.
Sign the Informed consent.
Exclusion Criteria:
The presence of a respiratory disease in the previous month, inability to understand assessment tests or intervention or hemodynamic alterations (heart rate > 150 beats per minute (bpm), systolic blood pressure > 140 millimeters mercury (mmHg) or diastolic blood pressure > 90 mmHg).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CARLOS MARTIN SANCHEZ, PHD
Phone
+34646774655
Email
carlos_ms@usal.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CARLOS MARTIN SANCHEZ, PHD
Organizational Affiliation
University of Salamanca
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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