Home-based Respiratory Training on Swallowing in Stroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Device: Respiratory training; Other: Orofacial exercises

• Registration Number: NCT06312319
• Lead Sponsor: Universidad de Granada

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2023-08-20
• Study First Submitted: 2024-01-31
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-13
• Last Update Submitted: 2024-03-14
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2024-03-20
• Study Completion: 2024-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Respiratory training added to orofacial exercises	Respiratory training	Home-based respiratory training of the inspiratory and expiratory muscles using a device added to standard treatment including orofacial exercises.
Orofacial exercises	Orofacial exercises	Standard treatment including orofacial exercises.
Respiratory training added to orofacial exercises	Orofacial exercises	Home-based respiratory training of the inspiratory and expiratory muscles using a device added to standard treatment including orofacial exercises.

Primary Outcome Measures

Name	Time	Method
Gugging Swallowing screen	Baseline, 6 weeks	Screening test that indicates the need to evaluate the presence of dysphagia. The scores ranges from 0 to 20, with higher scores indicating better performance. Twenty points are the highest score that a patient can attain, and it means normal swallowing ability without aspiration risk.
cough peak flow	Baseline, 6 weeks	Evaluation of the strength of cough using a peak flow meter
Swallowing quality of life questionnaire	Baseline, 6 weeks	Questionnaire evaluating the impact of swallowing deficits on daily living. The scores range from 0 to 100 metric, with a lower score indicating less quality of life.

Secondary Outcome Measures

Name	Time	Method
Forced expiratory volumen in the first second	Baseline, 6 weeks	refers to the volume of air that an individual can exhale during a forced breath in the first second.
Respiratory Pressure Meter	Baseline, 6 weeks	This measure will include the maximal inspiratory and maximal expiratory measures evaluated using a device
FEV1/FVC ratio	Baseline, 6 weeks	This is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs
Forced vital capacity	Baseline, 6 weeks	This is the maximum amount of air you can forcibly exhale from your lungs after fully inhaling

Trial Locations

Locations (1)

Faculty of Health Sciences; 🇪🇸 Granada, Spain