Home-based Respiratory Training on Swallowing in Stroke

University of Granada (UGR)

Status: Enrolling

Conditions: Stroke

Treatments: Device: Respiratory training; Other: Orofacial exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06312319

DF0001

Details and patient eligibility

About

The aim of this study is to evaluate the effects of a home-based respiratory muscle training on swallowing function in patients with chronic stroke. The patients will be included in a experimental or a control group. The patients in the experimental group will receive a home-based respiratory training using respiratory devices added to standard treatment, while the participants in the control group will only receive the standard treatment.

Full description

This study aims to evaluate the effects of a home-based respiratory muscle training on swallowing function in patients with chronic stroke. The patients will be included in a experimental or a control group. The patients in the experimental group will receive home-based respiratory training using respiratory devices added to standard treatment, while the participants in the control group will only receive the standard treatment. The swallowing function will be assessed using specific tools and questionnaires. Secondary outcomes will evaluate the respiratory function. The intervention will have a duration of 6 weeks.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of stroke
• 18 years of age or more

Exclusion criteria

• Cognitive impairment or aphasia that prevents the understanding of instructions.
• Tracheostomy.
• Presence of cancer.
• Patients who present another disease of the central nervous system
• Absence of neuromotor competence to carry out the respiratory function tests.
• Central apnea.
• Hypoventilation-obesity syndrome.
• Severe cardiorespiratory impairment (hemodynamic instability, pulmonary embolism, recent pneumonothorax, acute hemoptysis, active respiratory infections, recent myocardial infarction, unstable angina, pulmonary hypertension, uncontrolled asthma, or severe chronic obstructive pulmonary disease).
• Patients with recent otorhinolaryngological, abdominal, or thoracic surgery.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Respiratory training added to orofacial exercises

Experimental group

Description:

Home-based respiratory training of the inspiratory and expiratory muscles using a device added to standard treatment including orofacial exercises.

Treatment:

Other: Orofacial exercises

Device: Respiratory training

Orofacial exercises

Active Comparator group

Description:

Standard treatment including orofacial exercises.

Treatment:

Other: Orofacial exercises