Home-based Respiratory Training on Swallowing in Stroke

Stroke Clinical Trial

Official title:

Effects of a Home-based Respiratory Muscle Training on Swallowing Function in Patients With Chronic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06312319
• Other study ID #: DF0001
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2023
• Est. completion date: June 20, 2024

Study information

• Verified date: March 2024
• Source: Universidad de Granada
• Contact: Irene Cabrera Martos
• Phone: 958248763
• Email: irenecm[@]ugr.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 20, 2024
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Respiratory training
Respiratory training using the EMST 150 device to increase inspiratory and expiratory muscle strength.

Other:
• Orofacial exercises
The exercises will include activities to improve orofacial structures such as mobility, strength and coordination.

Locations

Country	Name	City	State
Spain	Faculty of Health Sciences	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gugging Swallowing screen	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.	Baseline, 6 weeks
Primary	Swallowing quality of life questionnaire	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.	Baseline, 6 weeks
Primary	cough peak flow	Evaluation of the strength of cough using a peak flow meter	Baseline, 6 weeks
Secondary	Forced vital capacity	This is the maximum amount of air you can forcibly exhale from your lungs after fully inhaling	Baseline, 6 weeks
Secondary	Forced expiratory volumen in the first second	refers to the volume of air that an individual can exhale during a forced breath in the first second.	Baseline, 6 weeks
Secondary	FEV1/FVC ratio	This is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs	Baseline, 6 weeks
Secondary	Respiratory Pressure Meter	This measure will include the maximal inspiratory and maximal expiratory measures evaluated using a device	Baseline, 6 weeks