StrokeNCT06328803
Impact of Active Breathing Exercises on Respiratory Rhythm Disorders in Stroke Patients
A study testing Rehabilitation training and Active Breathing Exercises in people with Stroke, run by Copka Sonpashan.
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
- Stroke
- 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
- No sites listed yet
- Study dates
- Mar 2024to Dec 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
No sites are listed yet.
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
- Stroke
- Being tested
- Rehabilitation training, Active Breathing Exercises
- Medical subject headings
- Stroke
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 |
|---|---|---|
| Rehabilitation training+Active Breathing Exercises | 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 |
| Rehabilitation training | 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.
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)
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 posted25 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copka Sonpashan
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Copka Sonpashan, Chao Phya Abhaibhubejhr Hospital
- Investigators
- Nieto Luis, Master, Study chair, Site Coordinator of United Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328803
- Sponsor's protocol ID
- Active Breathing Exercises
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 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
- NCT06328803
- Acronym / sponsor ID
- Active Breathing Exercises
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Copka SonpashanOther government
- Study start
- Mar 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Mar 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
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation training+Active Breathing Exercises | 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 |
| Rehabilitation training | 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 | Rehabilitation training, Rehabilitation training+Active Breathing Exercises |
| 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 | Rehabilitation training+Active Breathing Exercises |
Primary outcome
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
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 25 Mar 2024.
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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, Master study chair
Site Coordinator of United Medical Group
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation training and Active Breathing Exercises in people with Stroke, run by Copka Sonpashan.
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 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Lavie Ce, Master (15333866454, zengxizdyfy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 25 Mar 2024.