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Clinical Trials/NCT06249516
NCT06249516
Not yet recruiting
Not Applicable

A Randomized Controlled Trial to Explore Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder

Zeng Changhao1 site in 1 country80 target enrollmentApril 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Rhythm Disorder
Sponsor
Zeng Changhao
Enrollment
80
Locations
1
Primary Endpoint
The Penetration-Aspiration Scale
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups.

Detailed Description

A growing body of literature indicates the existence of a highly stable, coordinative relation between respiration and oropharyngeal swallowing in healthy adults. The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups.

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

Investigators

Sponsor
Zeng Changhao
Responsible Party
Sponsor Investigator
Principal Investigator

Zeng Changhao

Head of R&D

People's Hospital of Zhengzhou University

Eligibility Criteria

Inclusion Criteria

  • diagnosed with Respiratory Rhythm Disorder
  • age ≥ 18 years;
  • meeting the diagnostic criteria of stroke;
  • any degree of dysphagia at admission;
  • steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
  • transferred out within three weeks of hospitalization in the neurology department.

Exclusion Criteria

  • complicated with other neurological diseases;
  • tracheostomy tube plugged;
  • unfeasible to the support of parenteral nutrition;
  • simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.

Outcomes

Primary Outcomes

The Penetration-Aspiration Scale

Time Frame: day 1 and day 15

The Penetration-Aspiration Scale is used to assess the severity of airway invasion during swallowing. The score ranges from 1 to 8, with higher scores indicating more severe penetration or aspiration events. A lower score indicates better swallowing function and less risk of airway invasion, while a higher score suggests more significant impairment and increased risk of aspiration.

Secondary Outcomes

  • Yale Pharyngeal Residue Severity Rating Scale(day 1 and day 15)
  • Murray Secretion Scale(day 1 and day 15)
  • Functional Oral Intake Scale(day 1 and day 15)
  • Swallowing Quality of Life(day 1 and day 15)
  • Fiberoptic Endoscopic Dysphagia Severity Scale(day 1 and day 15)

Study Sites (1)

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