StrokeNCT03153345
The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients
A study testing bedside respiratory muscle training and conventional stroke rehabilitation program in people with Stroke and Rehabilitation, run by Korea University Anam Hospital.
Trial summary
Objectives: To investigate the efficacy of bedside respiratory muscle training on pulmonary function and stroke-related disabilities in stroke patients. Design: Prospective randomized controlled trial Setting: A single physical medicine and rehabilitation department at a university hospital Participants: Stroke… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Rehabilitation, Breathing Exercise
- What is being tested?
- bedside respiratory muscle training and conventional stroke rehabilitation program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 31 Dec 2016
- 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
- older than 18 years of age,
- first episode of stroke within three months,
- moderate to severe stroke impairment, defined as a NIHSS score from 5-36, and
- the ability to follow instructions and engage in the study program.
Who cannot join
- a medical history of persistent cardiopulmonary disease,
- other coexisting brain disorders, such as brain tumor,
- poorly controlled hypertension, which was defined as a blood pressure higher than 180/100 mmHg during the preceding 24 hours,
- severe facial palsy or other oropharyngeal structural abnormality,
- severe oral apraxia, and (6) having a tracheostomy.
About this study
Official title: The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients: A Randomized Controlled Trial
Objectives: To investigate the efficacy of bedside respiratory muscle training on pulmonary function and stroke-related disabilities in stroke patients.
Design: Prospective randomized controlled trial
Read more
Setting: A single physical medicine and rehabilitation department at a university hospital
Participants: Stroke patients in a rehabilitation unit were recruited and randomly assigned to either the intervention group or the control group.
Intervention: Both groups participated in a conventional stroke rehabilitation program. During the study period, the intervention group received bedside respiratory muscle training twice a day for three weeks. The respiratory muscle training consisted of (1) a breath stacking exercise, (2) inspiratory muscle training and (3) expiratory muscle training. The participants were evaluated at baseline and again at the end of the study (3 weeks later).
Main Outcome Measures: The primary outcomes were measures of pulmonary function: functional vital capacity (FVC), forced expiratory volume in one second (FEV1) and peak flow.
Secondary outcomes were stroke-related disabilities assessed by the following: National Institutes of Health Stroke Scale, Modified Barthel Index, Berg Balance Scale, Fugl-Meyer Assessment, the Korean Mini-Mental State Examination, and the incidence of pneumonia.
- Conditions
- Stroke, Rehabilitation, Breathing Exercise, Pneumonia, Respiration
- Being tested
- bedside respiratory muscle training, conventional stroke rehabilitation program
- Medical subject headings
- Stroke, Pneumonia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bedside respiratory muscle trainingDevice
The program consisted of three sessions: (1) 10 minutes of breath stacking exercise, followed by (2) 10 minutes of inspiratory muscle training using a flow-oriented incentive spirometer and (3) 10 minutes of expiratory muscle training using Acapella vibratory PEP device.
conventional stroke rehabilitation programBehavioural
The program consisted of joint range of motion exercises, muscle strengthening, gait training, fine motor exercises, and activity of daily living training.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group participated in a conventional stroke rehabilitation program, which consisted of joint range of motion exercises, muscle strengthening, gait training, fine motor exercises, and activity of daily living training. This program was performed for 30 minutes twice a day 5 days a week, over for at least 3 weeks. During the same period, the intervention group also took part in bedside respiratory muscle training twice a day for 7 days a week over a 3-week period. Receives: Device: bedside respiratory muscle training; Behavioral: conventional stroke rehabilitation program |
| Control group | Active comparator | The control group participated only in a conventional stroke rehabilitation program, which consisted of joint range of motion exercises, muscle strengthening, gait training, fine motor exercises, and activity of daily living training. This program was performed for 30 minutes twice a day 5 days a week, over for at least 3 weeks. Receives: Behavioral: conventional stroke rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional vital capacity
functional vital capacity in percent (%)
Measured: 21 days
Forced expiratory volume
Forced expiratory volume in one second in percent (%)
Measured: 21 days
Peak flow
Peak flow in milliliter
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 Mar 2015
- Primary completion31 Oct 2016
- Study completion31 Dec 2016
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Joon Yoo, Korea University Anam Hospital
- Investigators
- Sung-Bom Pyun, M.D, Ph.D, Study chair, Department of Physical Medicine and Rehabilitation, Korea University Anam Hospital, Korea University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153345
- Sponsor's protocol ID
- KoreaUAnamHRehab
- Status last verified
- May 2017
- First submitted
- 8 May 2017
- Last updated
- 15 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03153345
- Acronym / sponsor ID
- KoreaUAnamHRehab
- Conditions
- Stroke, Rehabilitation, Breathing Exercise, Pneumonia, Respiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 15 May 2017 (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.
Objectives: To investigate the efficacy of bedside respiratory muscle training on pulmonary function and stroke-related disabilities in stroke patients.
Design: Prospective randomized controlled trial
Setting: A single physical medicine and rehabilitation department at a university hospital
Participants: Stroke patients in a rehabilitation unit were recruited and randomly assigned to either the intervention group or the control group.
Intervention: Both groups participated in a conventional stroke rehabilitation program. During the study period, the intervention group received bedside respiratory muscle training twice a day for three weeks. The respiratory muscle training consisted of (1) a breath stacking exercise, (2) inspiratory muscle training and (3) expiratory muscle training. The participants were evaluated at baseline and again at the end of the study (3 weeks later).
Main Outcome Measures: The primary outcomes were measures of pulmonary function: functional vital capacity (FVC), forced expiratory volume in one second (FEV1) and peak flow.
Secondary outcomes were stroke-related disabilities assessed by the following: National Institutes of Health Stroke Scale, Modified Barthel Index, Berg Balance Scale, Fugl-Meyer Assessment, the Korean Mini-Mental State Examination, and the incidence of pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: bedside respiratory muscle training, Behavioral: conventional stroke rehabilitation programThe intervention group participated in a conventional stroke rehabilitation program, which consisted of joint range of motion exercises, muscle strengthening, gait training, fine motor exercises, and activity of daily living training. This program was performed for 30 minutes twice a day 5 days a week, over for at least 3 weeks. During the same period, the intervention group also took part in bedside respiratory muscle training twice a day for 7 days a week over a 3-week period. |
| Control group | Active comparator | Behavioral: conventional stroke rehabilitation programThe control group participated only in a conventional stroke rehabilitation program, which consisted of joint range of motion exercises, muscle strengthening, gait training, fine motor exercises, and activity of daily living training. This program was performed for 30 minutes twice a day 5 days a week, over for at least 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- older than 18 years of age,
- first episode of stroke within three months,
- moderate to severe stroke impairment, defined as a NIHSS score from 5-36, and
- the ability to follow instructions and engage in the study program.
Key exclusion criteria (5 listed)
- a medical history of persistent cardiopulmonary disease,
- other coexisting brain disorders, such as brain tumor,
- poorly controlled hypertension, which was defined as a blood pressure higher than 180/100 mmHg during the preceding 24 hours,
- severe facial palsy or other oropharyngeal structural abnormality,
- severe oral apraxia, and (6) having a tracheostomy.
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 |
|---|---|---|
| bedside respiratory muscle trainingThe program consisted of three sessions: (1) 10 minutes of breath stacking exercise, followed by (2) 10 minutes of inspiratory muscle training using a flow-oriented incentive spirometer and (3) 10 minutes of expiratory muscle training using Acapella vibratory PEP device. | Device | Intervention group |
| conventional stroke rehabilitation programThe program consisted of joint range of motion exercises, muscle strengthening, gait training, fine motor exercises, and activity of daily living training. | Behavioural | Control group, Intervention group |
Primary outcome
functional vital capacity
Time frame: 21 days
functional vital capacity in percent (%)
Forced expiratory volume
Time frame: 21 days
Forced expiratory volume in one second in percent (%)
Peak flow
Time frame: 21 days
Peak flow in milliliter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
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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.
Sung-Bom Pyun, M.D, Ph.D study chair
Department of Physical Medicine and Rehabilitation, Korea University Anam Hospital, Korea University College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing bedside respiratory muscle training and conventional stroke rehabilitation program in people with Stroke and Rehabilitation, run by Korea University Anam Hospital.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 15 May 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional vital capacity (time frame: 21 days). The study lists 3 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 15 May 2017.