Impact of Active Breathing Exercises on Respiratory Rhythm Disorders in Stroke Patients
A Randomized Controlled Trial to Explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder
1 other identifier
interventional
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Mar 2024
Shorter than P25 for not_applicable stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2024
CompletedFirst Submitted
Initial submission to the registry
March 10, 2024
CompletedFirst Posted
Study publicly available on registry
March 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMarch 25, 2024
March 1, 2024
9 months
March 10, 2024
March 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Penetration-Aspiration Scale
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.
day 1 and day 15
Secondary Outcomes (5)
Functional Oral Intake Scale
day 1 and day 15
Yale Pharyngeal Residue Severity Rating Scale
day 1 and day 15
Fiberoptic Endoscopic Dysphagia Severity Scale
day 1 and day 15
Murray Secretion Scale
day 1 and day 15
Swallowing Quality of Life
day 1 and day 15
Study Arms (2)
Rehabilitation training+Active Breathing Exercises
EXPERIMENTALAssigned by the random number table. During the treatment, all patients were provided with comprehensive rehabilitation therapy as follows: Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. Based on this, this group was given Active Breathing Exercises
Rehabilitation training
ACTIVE COMPARATORAssigned by the random number table. During the treatment, all patients were provided with comprehensive rehabilitation therapy as follows: Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Copka Sonpashanlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nieto Luis, Master
Site Coordinator of United Medical Group
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- The Research Director
Study Record Dates
First Submitted
March 10, 2024
First Posted
March 25, 2024
Study Start
March 1, 2024
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
March 25, 2024
Record last verified: 2024-03