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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
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 23, 2023
    Last Updated
    September 30, 2023
    Sponsor
    University of Salamanca
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    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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