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The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06265818
Acronym
ABE-S
Enrollment
80
Registered
2024-02-20
Start date
2024-03-01
Completion date
2024-05-31
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Rhythm Disorder

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.

Interventions

Including 1) Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. 2)Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training.

Active breathing exercises aim to enhance the strength and flexibility of respiratory muscles through a series of exercises, improving breathing patterns and increasing respiratory efficiency. The following are common components of active breathing exercises: 1) Deep Breathing. 2) Chest Expansion. 3) Diaphragmatic Breathing. 4) Coughing Techniques. 5) Expiratory Resistance Training. 6) Gradual Increase in Activity.

Sponsors

Zeng Changhao
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The Penetration-Aspiration Scaleday 1 and day 15The 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

MeasureTime frameDescription
The Functional Oral Intake Scaleday 1 and day 15The Functional Oral Intake Scale is used to measure the level of oral intake and diet consistency in individuals with dysphagia. The score ranges from 1 to 7, with higher scores indicating better functional oral intake and tolerance to a wider variety of food textures. A higher score indicates improved swallowing function and the ability to consume a better range of food consistencies, while a lower score suggests more significant impairments and a limited intake of oral food and liquids.
Yale Pharyngeal Residue Severity Rating Scaleday 1 and day 15The Yale Pharyngeal Residue Severity Rating Scale is used to assess the severity of pharyngeal residue after swallowing. The scale ranges from 1 to 5, with higher scores indicating worse severity of pharyngeal residue. A higher score on the Yale Pharyngeal Residue Severity Rating Scale indicates a larger amount of residue remaining in the pharynx after swallowing, while a lower score suggests less residue and better swallowing efficiency.
Fiberoptic Endoscopic Dysphagia Severity Scaleday 1 and day 15The Fiberoptic Endoscopic Dysphagia Severity Scale is used to assess the severity of swallowing disorders based on fiberoptic endoscopic examination. The score ranges from 1 to 8, with higher scores indicating more severe swallowing impairment.
Murray Secretion Scaleday 1 and day 15The Murray Secretion Scale is used to assess the amount and tenacity of tracheobronchial secretions. The score ranges from 0 to 4, with higher scores indicating a greater amount and/or thicker consistency of secretions. A higher score indicates a higher volume or thicker consistency of tracheobronchial secretions, while a lower score suggests minimal secretion accumulation and easier secretion management.
Swallowing Quality of Lifeday 1 and day 15Swallowing Quality of Life is a self-report questionnaire designed to assess the impact of dysphagia on an individual's quality of life. The score ranges from 0 to 100, with higher scores indicating better swallowing-related quality of life. A higher score indicates a better quality of life related to swallowing function, while a lower score suggests a poorer quality of life and greater negative impact of dysphagia on daily activities and well-being.

Countries

South Korea

Contacts

Primary ContactZhefeng Wang, Master
zhengzhouzhj@qq.com19501376864
Backup ContactWeiji Zhao, Master
zwjww2009@163.com17839973473

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026