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Clinical Trials/NCT06312319
NCT06312319
Recruiting
N/A

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

Universidad de Granada1 site in 1 country40 target enrollmentAugust 20, 2023
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Universidad de Granada
Enrollment
40
Locations
1
Primary Endpoint
Gugging Swallowing screen
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 20, 2023
End Date
June 20, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Irene Cabrera Martos

Profesor titular de Universidad

Universidad de Granada

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Gugging Swallowing screen

Time Frame: 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

Time Frame: Baseline, 6 weeks

Evaluation of the strength of cough using a peak flow meter

Swallowing quality of life questionnaire

Time Frame: 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 Outcomes

  • Forced expiratory volumen in the first second(Baseline, 6 weeks)
  • Respiratory Pressure Meter(Baseline, 6 weeks)
  • FEV1/FVC ratio(Baseline, 6 weeks)
  • Forced vital capacity(Baseline, 6 weeks)

Study Sites (1)

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