Home-based Respiratory Training on Swallowing in Stroke

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Respiratory training; Other: Orofacial exercises

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irene Cabrera Martos; Phone Number: 958248763; Email: irenecm@ugr.es
• Study Contact Backup: Name: Irene Cabrera Martos; Email: irenecm@ugr.es

Study Locations

• Spain
  • Granada, Spain, 18016
    • Recruiting
    • Faculty of Health Sciences
    • Contact: Irene Cabrera Martos; Email: irenecm@ugr.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Respiratory training added to orofacial exercises; Home-based respiratory training of the inspiratory and expiratory muscles using a device added to standard treatment including orofacial exercises.	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.
Active Comparator: Orofacial exercises; Standard treatment including orofacial exercises.	Other: Orofacial exercises; The exercises will include activities to improve orofacial structures such as mobility, strength and coordination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
cough peak flow	Evaluation of the strength of cough using a peak flow meter	Baseline, 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced vital capacity	This is the maximum amount of air you can forcibly exhale from your lungs after fully inhaling	Baseline, 6 weeks
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
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
Respiratory Pressure Meter	This measure will include the maximal inspiratory and maximal expiratory measures evaluated using a device	Baseline, 6 weeks

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: Irene Cabrera Martos, Ugr

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2023
• Primary Completion (Estimated): March 20, 2024
• Study Completion (Estimated): June 20, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: DF0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No