Respiratory Rhythm DisorderABE-SNCT06265818
The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder
A study testing Rehabilitation training and Active Breathing Exercises in people with Respiratory Rhythm Disorder, run by Zeng Changhao at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Rhythm Disorder
- What is being tested?
- Rehabilitation training and Active Breathing Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2024to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Center Rehabilitation Hospital
Seoul
Wei Liu, Master
About this study
Official title: A Randomized Controlled Trial to Explore The 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.
Read the 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.
- Conditions
- Respiratory Rhythm Disorder
- Being tested
- Rehabilitation training, Active Breathing Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation trainingBehavioural
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 ExercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1 and day 15
Secondary outcomes (5)
The 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: day 1 and day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Mar 2024
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Rhythm DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeng Changhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeng Changhao, People's Hospital of Zhengzhou University
- Investigators
- Nieto Luis, Doctor, Study director, Site Coordinator of United Medical Group located in Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265818
- Sponsor's protocol ID
- 2024-KY-0126
- Acronym
- ABE-S
- Status last verified
- Mar 2024
- First submitted
- 26 Jan 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder
- ClinicalTrials.gov ID
- NCT06265818
- Acronym / sponsor ID
- ABE-S / 2024-KY-0126
- Conditions
- Respiratory Rhythm Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zeng ChanghaoUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Behavioral: Rehabilitation training, Behavioral: Active Breathing ExercisesAssigned 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 |
| The control group | Active comparator | Behavioral: Rehabilitation trainingAssigned 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation trainingIncluding 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. | Behavioural | The control group, The experimental group |
| Active Breathing ExercisesActive 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. | Behavioural | The experimental group |
Primary outcome
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.
5 secondary outcomes
The Functional Oral Intake Scale
Time frame: day 1 and day 15
Yale Pharyngeal Residue Severity Rating Scale
Time frame: day 1 and day 15
Fiberoptic Endoscopic Dysphagia Severity Scale
Time frame: day 1 and day 15
Murray Secretion Scale
Time frame: day 1 and day 15
Swallowing Quality of Life
Time frame: day 1 and day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nieto Luis, Doctor study director
Site Coordinator of United Medical Group located in Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation training and Active Breathing Exercises in people with Respiratory Rhythm Disorder, run by Zeng Changhao at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhefeng Wang, Master (19501376864, zhengzhouzhj@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Penetration-Aspiration Scale (time frame: day 1 and day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.