Stroke, IschemicNCT04949334
Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke
A study testing Dofin Breathing Strength Builder in people with Stroke, Ischemic, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
After acute ischemic stroke, the muscle strength of the limbs of the patients will decrease. Moreover, the respiratory muscles may also be affected. The respiratory muscle training may improve the respiratory recovery and prevent pulmonary complication. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Dofin Breathing Strength Builder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Sep 2021to 15 Jul 2023
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke diagnosed by MRI
- Age over 20 years old
- No worsening of stroke or second stroke this time
Who cannot join
- Unable to understand instructions normally, or communication difficulties
- Patients with endotracheal tube or tracheostomy
- Angina in recent 3 months, myocardial infarction, heart failure
- Patients with asthma or chronic obstructive pulmonary disease, spontaneous pneumothorax, and ongoing pneumonia
- Patients with untreated hernias
- Pregnant
Show all 9Show fewer
- Ongoing fever (body temperature>38.5°C)
- Poor hypertension control (higher than 170/100 mmHg three days before intervention)
- Patients who have had cerebral hemorrhage or aneurysm
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Shuang Ho Hospital, Taipei Medical University
New Taipei City, 235
Ruey Chen, PhD, 886-2-2249088 ext. 8620, 18622@s.tmu.edu.tw
Tzu-Ang Chen, MD, 886-915855505, b101103035@tmu.edu.tw
About this study
After acute ischemic stroke, the muscle strength of the limbs of the patients will decrease. Moreover, the respiratory muscles may also be affected. The respiratory muscle training may improve the respiratory recovery and prevent pulmonary complication.
Read the detailed description
After acute ischemic stroke, the muscle strength of the limbs of the patients will decrease. Moreover, the respiratory muscles may also be affected. The worsening of the respiratory function is weakened and lung function declines, leading to dysfunction of expectoration and swallowing, and increasing the incidence of pneumonia after stroke. In addition, it will also lead to a decline in activity ability, which in turn affects the quality of life. The respiratory muscle training may improve the respiratory recovery and prevent pulmonary complication.
- Conditions
- Stroke, Ischemic
- Being tested
- Dofin Breathing Strength Builder
- Keywords
- Stroke, Respiratory muscle training, Respiratory function
- Medical subject headings
- Ischemic Stroke, Stroke, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dofin Breathing Strength BuilderDevice
If the patient's condition is stable, respiratory muscle training will be performed under Dofin Breathing Strength Builder 7 days after stroke. The patient will receive respiratory muscle training by repetition of 30 times, two courses per day, x 7 days, for three weeks.
The initial load was set at 30% of the participants' maximal baseline strength and increased weekly at intervals of 2 cmH2O.
| Study group | Role | What they receive |
|---|---|---|
| Dofin Breathing Strength Builder | Experimental | Usual post stroke care and respiratory muscle training Receives: Device: Dofin Breathing Strength Builder |
| Usual post stroke care | No intervention | Usual post stroke care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle function-1.1
MEP (maximal expiratory pressure)
Measured: Baseline
Respiratory muscle function-1.2
MEP (maximal expiratory pressure)
Measured: Within one week after training
Respiratory muscle function-1.3
MEP (maximal expiratory pressure)
Measured: Twelve weeks after training
Respiratory muscle function-2.1
MIP (maximal inspiratory pressure)
Measured: Baseline
Respiratory muscle function-2.2
MIP (maximal inspiratory pressure)
Measured: Within one week after training
Respiratory muscle function-2.3
MIP (maximal inspiratory pressure)
Measured: Twelve weeks after training
Secondary outcomes (15)
Dyspnea.1
Dyspnea assessed by Modified Borg Dyspnea Scale (MBS). MBS can go from 0-10, 10 is the more severe condition.
Measured: Baseline
Dyspnea.2
Dyspnea assessed by Modified Borg Dyspnea Scale (MBS). MBS can go from 0-10, 10 is the more severe condition.
Measured: Within one week after training
Dyspnea.3
Dyspnea assessed by Modified Borg Dyspnea Scale (MBS). MBS can go from 0-10, 10 is the more severe condition.
Measured: Twelve weeks after training
Exercise tolerance.1
Exercise tolerance assessed by six-minute walk test (6MWT).
Measured: Baseline
Exercise tolerance.2
Exercise tolerance assessed by six-minute walk test (6MWT).
Measured: Within one week after training
Exercise tolerance.3
Exercise tolerance assessed by six-minute walk test (6MWT).
Measured: Twelve weeks after training
Body composition.1
Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).
Measured: Baseline
Body composition.2
Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).
Measured: Within one week after training
Body composition.3
Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).
Measured: Twelve weeks after training
Life quality.1
Quality of life assessed by Short-form 12 (SF-12). SF-12 can go from 0-100, 100 is the better life quality.
Measured: Baseline
Life quality.2
Quality of life assessed by Short-form 12 (SF-12). SF-12 can go from 0-100, 100 is the better life quality.
Measured: Within one week after training
Life quality.3
Quality of life assessed by Short-form 12 (SF-12). SF-12 can go from 0-100, 100 is the better life quality.
Measured: Twelve weeks after training
Swallowing.1
Swallowing function assessed by the Functional Oral Intake Scale (FOIS). The score can go from 1-7, 7 is the better oral intake condition.
Measured: Baseline
Swallowing.2
Swallowing function assessed by the Functional Oral Intake Scale (FOIS). The score can go from 1-7, 7 is the better oral intake condition.
Measured: Within one week after training
Swallowing.3
Swallowing function assessed by the Functional Oral Intake Scale (FOIS). The score can go from 1-7, 7 is the better oral intake condition.
Measured: Twelve weeks after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start23 Sep 2021
- Primary completion15 Jan 2023 (estimated)
- Study completion15 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen ruey, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949334
- Sponsor's protocol ID
- N202009012
- Status last verified
- Sep 2021
- First submitted
- 4 Feb 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04949334
- Acronym / sponsor ID
- N202009012
- Conditions
- Stroke, Ischemic
- Keywords
- Stroke, Respiratory muscle training, Respiratory function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 15 Jan 2023 (estimated)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 2 Jul 2021 (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.
After acute ischemic stroke, the muscle strength of the limbs of the patients will decrease. Moreover, the respiratory muscles may also be affected. The respiratory muscle training may improve the respiratory recovery and prevent pulmonary complication.
Detailed description
After acute ischemic stroke, the muscle strength of the limbs of the patients will decrease. Moreover, the respiratory muscles may also be affected. The worsening of the respiratory function is weakened and lung function declines, leading to dysfunction of expectoration and swallowing, and increasing the incidence of pneumonia after stroke. In addition, it will also lead to a decline in activity ability, which in turn affects the quality of life. The respiratory muscle training may improve the respiratory recovery and prevent pulmonary complication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dofin Breathing Strength Builder | Experimental | Device: Dofin Breathing Strength BuilderUsual post stroke care and respiratory muscle training |
| Usual post stroke care | No intervention | –Usual post stroke care |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ischemic stroke diagnosed by MRI
- Age over 20 years old
- No worsening of stroke or second stroke this time
Key exclusion criteria (9 listed)
- Unable to understand instructions normally, or communication difficulties
- Patients with endotracheal tube or tracheostomy
- Angina in recent 3 months, myocardial infarction, heart failure
- Patients with asthma or chronic obstructive pulmonary disease, spontaneous pneumothorax, and ongoing pneumonia
- Patients with untreated hernias
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 |
|---|---|---|
| Dofin Breathing Strength BuilderIf the patient's condition is stable, respiratory muscle training will be performed under Dofin Breathing Strength Builder 7 days after stroke. The patient will receive respiratory muscle training by repetition of 30 times, two courses per day, x 7 days, for three weeks. The initial load was set at 30% of the participants' maximal baseline strength and increased weekly at intervals of 2 cmH2O. | Device | Dofin Breathing Strength Builder |
Primary outcome
Respiratory muscle function-1.1
Time frame: Baseline
MEP (maximal expiratory pressure)
Respiratory muscle function-1.2
Time frame: Within one week after training
MEP (maximal expiratory pressure)
Respiratory muscle function-1.3
Time frame: Twelve weeks after training
MEP (maximal expiratory pressure)
Respiratory muscle function-2.1
Time frame: Baseline
MIP (maximal inspiratory pressure)
Respiratory muscle function-2.2
Time frame: Within one week after training
MIP (maximal inspiratory pressure)
Respiratory muscle function-2.3
Time frame: Twelve weeks after training
MIP (maximal inspiratory pressure)
15 secondary outcomes
Dyspnea.1
Time frame: Baseline
Dyspnea.2
Time frame: Within one week after training
Dyspnea.3
Time frame: Twelve weeks after training
Exercise tolerance.1
Time frame: Baseline
Exercise tolerance.2
Time frame: Within one week after training
Exercise tolerance.3
Time frame: Twelve weeks after training
Body composition.1
Time frame: Baseline
Body composition.2
Time frame: Within one week after training
Body composition.3
Time frame: Twelve weeks after training
Life quality.1
Time frame: Baseline
Life quality.2
Time frame: Within one week after training
Life quality.3
Time frame: Twelve weeks after training
Swallowing.1
Time frame: Baseline
Swallowing.2
Time frame: Within one week after training
Swallowing.3
Time frame: Twelve weeks after training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dofin Breathing Strength Builder in people with Stroke, Ischemic, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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 3 inclusion and 9 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 24 Sep 2021. 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 Taiwan. 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 Ruey Chen, PhD (886-2-2249088 ext. 8620, 18622@s.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle function-1.1 (time frame: Baseline). The study lists 6 primary outcomes in all. 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 24 Sep 2021.