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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Rhythm Disorder
• Intervention / Treatment: Behavioral: Rehabilitation training; Biological: Active Breathing Exercises

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weijia Li, Master; Phone Number: 13592505588; Email: liweijia@163.com
• Study Contact Backup: Name: Qianyun Lu, Master; Phone Number: 15333866454; Email: luqianyun@126.com

Study Locations

• Taiwan
  • Xinzhu, Taiwan
    • Xinzhu Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The experimental group; Assigned 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	Behavioral: Rehabilitation training; 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.; Biological: Active Breathing Exercises; 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.
Active Comparator: The control group; Assigned 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.	Behavioral: Rehabilitation training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Oral Intake Scale	The 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.	day 1 and day 15
Yale Pharyngeal Residue Severity Rating Scale	The 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.	day 1 and day 15
Fiberoptic Endoscopic Dysphagia Severity Scale	The 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.	day 1 and day 15
Murray Secretion Scale	The 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.	day 1 and day 15
Swallowing Quality of Life	Swallowing 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.	day 1 and day 15

Collaborators and Investigators

• Sponsor: Zeng Changhao
• Collaborators: People's Hospital of Zhengzhou University
• Investigators: Principal Investigator: Nieto Luis, Master, Site Coordinator of United Medical Group located in Miami

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders
• Other Study ID Numbers: Zhudonghuxi-Huxijielv

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No