Stroke
Conditions
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.
Interventions
DEVICERespiratory training
Respiratory training using the EMST 150 device to increase inspiratory and expiratory muscle strength.
OTHEROrofacial exercises
The exercises will include activities to improve orofacial structures such as mobility, strength and coordination.
Sponsors
Universidad de Granada
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| cough peak flow | Baseline, 6 weeks | Evaluation of the strength of cough using a peak flow meter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced vital capacity | Baseline, 6 weeks | This is the maximum amount of air you can forcibly exhale from your lungs after fully inhaling |
| Respiratory Pressure Meter | Baseline, 6 weeks | This measure will include the maximal inspiratory and maximal expiratory measures evaluated using a device |
| 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. |
| 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 |
Countries
Spain
Contacts
Primary ContactIrene Cabrera Martos
Backup ContactIrene Cabrera Martos
Outcome results
None listed