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Respiratory Muscle Training in Acquired Brain Injury Patients.

Comparison Between Two Respiratory Muscle Training Protocols: Inspiratory Muscle Training vs Expiratory Muscle Training in Acquired Brain Injury Patients.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06070831
Enrollment
26
Registered
2023-10-06
Start date
2023-12-21
Completion date
2024-04-21
Last updated
2023-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Brain Injury, Muscle Weakness, Older People--Abuse of, Physical Inactivity, Respiratory Disease

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.

Interventions

DEVICEInspiratory muscle training

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.

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.

Sponsors

University of Salamanca
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

The professional that collected the data and the participants were unaware of group assignment.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Inspiratory muscle strength8 weeks.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 strength8 weeks.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

MeasureTime frameDescription
Pulmonary volume.8 weeks.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.8 weeks.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).

Contacts

Primary ContactCARLOS MARTIN SANCHEZ, PHD
carlos_ms@usal.es+34646774655

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026