Respiratory Muscle Training in Acquired Brain Injury Patients.

Not Applicable

Not yet recruiting

• Conditions: Physical Inactivity; Muscle Weakness; Respiratory Disease; Acquired Brain Injury; Older People--Abuse of
• Interventions: Device: Inspiratory muscle training; Device: Expiratory muscle training

• Registration Number: NCT06070831
• Lead Sponsor: University of Salamanca

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-23
• Study First Submitted QC: 2023-09-30
• Last Update Submitted: 2023-09-30
• Study First Posted: 2023-10-06
• Last Update Posted: 2023-10-06
• Study Start: 2023-12-21
• Primary Completion: 2024-02-21
• Study Completion: 2024-04-21

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inspiratory muscle training group (IMT)	Inspiratory muscle training	Inspiratory muscle training at 50% of MIP, the training load was set each 2 weeks to keep 50% of MIP.
Expiratory muscle training group (EMT)	Expiratory muscle training	Expiratory muscle training at 50% of MEP, following the same rules as HIT.

Primary Outcome Measures

Name	Time	Method
Inspiratory muscle strength	8 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 strength	8 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 Outcome Measures

Name	Time	Method
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).