Respiratory Muscle Training in Acquired Brain Injury Patients.

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06070831
• Other study ID #: 23092023
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 21, 2023
• Est. completion date: April 21, 2024

Study information

• Verified date: September 2023
• Source: University of Salamanca
• Contact: CARLOS MARTIN SANCHEZ, PHD
• Phone: +34646774655
• Email: carlos_ms[@]usal.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: April 21, 2024
• Est. primary completion date: February 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Muscle Weakness
• Older People--Abuse of
• Physical Inactivity
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Wounds and Injuries

Intervention

Device:
• Inspiratory 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.
• Expiratory muscle training
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	8 weeks.
Primary	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).	8 weeks.
Secondary	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).	8 weeks.
Secondary	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).	8 weeks.