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

NCT06265818 | Recruiting DMC

• 1 other identifier: 2024-KY-0126
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Rhythm Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The 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)

The experimental group

EXPERIMENTAL

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; Behavioral: Active Breathing Exercises

The control group

ACTIVE COMPARATOR

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

Interventions

Rehabilitation training BEHAVIORAL

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.

The control group; The experimental group

Active Breathing Exercises BEHAVIORAL

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.

The experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Zeng Changhao: lead

Study Sites (1)

Center Rehabilitation Hospital

Seoul, South Korea

RECRUITING

Study Officials

• Nieto Luis, Doctor

  Site Coordinator of United Medical Group located in Miami

  STUDY DIRECTOR

Central Study Contacts

Zhefeng Wang, Master

CONTACT

19501376864; zhengzhouzhj@qq.com

Weiji Zhao, Master

CONTACT

17839973473; zwjww2009@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 20, 2024
• Study Start: March 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)