BronchiectasisNCT05408455
Expiratory Muscle Training in Bronchiectasis
A study testing EMST150 (Expiratory muscle training) in people with Bronchiectasis, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Reduced exercise tolerance is commonly reported in patients with bronchiectasis. The purpose of this study is to evaluate the effects of expiratory muscle training (EMT) and sham EMT (control) on exercise capacity, respiratory function and respiratory muscle strength, cough strength and health related quality of life… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- EMST150 (Expiratory muscle training)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 23 Jan 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinically stable patients who do not meet the definition of exacerbation,
- Those with a diagnosis of non-CF bronchiectasis,
- Patients are between the ages of 18-70
- Patients without acute and/or chronic respiratory failure,
- Patients who do not have any contraindications for the physiotherapy method to be applied.
Who cannot join
- Those with a history of pneumothorax,
- Patients younger than 18 years
- Patients older than 70 years
- Presence of cor pulmonale and/or heart failure,
- Patients with hemoptysis,
- Those with a recent history of acute myocardial infarction,
Show all 13Show fewer
- Presence of spinal cord injury,
- Those with unstable intervertebral disc, rib fracture,
- Patients with severe osteoporosis,
- Those who had an infective exacerbation during the physiotherapy application period,
- Those who are found to have respiratory distress that will require hospitalization,
- If there is a wound in the application area,
- If there is infection or hemorrhage in the application area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Expiratory Muscle Training in Bronchiectasis Patients
Reduced exercise tolerance is commonly reported in patients with bronchiectasis. The purpose of this study is to evaluate the effects of expiratory muscle training (EMT) and sham EMT (control) on exercise capacity, respiratory function and respiratory muscle strength, cough strength and health related quality of life in patients with bronchiectasis.
Read the detailed description
Disruption of the mucociliary clearance mechanism in patients with bronchiectasis leaves the lungs vulnerable. With the accumulation of secretions, a vicious cycle of bacterial infection and inflammation begins. Intense inflammation causes damage and bronchial wall weakness. Problems arise with effective coughing. This leads to decreased clearance of secretions, resulting in decreased expiratory flow. Symptoms of bronchiectasis; often productive cough, dyspnea, fatigue and wheezing. Altered pulmonary mechanics, inadequate gas exchange, decreased muscle mass, and accompanying psychological problems can cause dyspnea and decreased exercise capacity, thus reducing quality of life. Exercise capacity may also decrease in individuals with bronchiectasis due to increased dyspnea perception and limitation of expiratory flow. The need for safe and viable exercise interventions to reduce the burden of the disease is evident in individuals with bronchiectasis. Respiratory muscle training is applied by using skeletal muscle training principles in order to increase respiratory muscle strength and endurance, to correct the length-tension relationship of respiratory muscles and to increase respiratory capacity. Decreased expiratory muscle strength is associated with decreased quality of life and exercise tolerance. In addition, in a study, it was shown that in addition to expiratory muscle weakness, expiratory muscle endurance decreases in respiratory patients. This decrease is closely related to the severity of airway obstruction and the decrease in the strength of other muscle groups.
In order to meet the increased metabolic needs during exercise and to keep gas exchange at a sufficient level, patients with bronchiectasis; they must increase minute ventilation as appropriate. These patients with expiratory flow limitation at rest breathe at higher lung volumes to increase ventilation during exercise, and as a result, adverse conditions such as worsening of dynamic hyperinflation, increased intrinsic PEEP, increased workload on respiratory muscles and dyspnea are observed. As a result, these patients cannot achieve high levels of tidal volume and ventilation. In addition, significantly reduced maximal voluntary ventilation in patients with flow-limited bronchiectasis; It is also related to airway obstruction and mechanical deterioration. Decreased exercise capacity has also been shown to be associated with peak exercise desaturation. Those with abnormal lung mechanics (low FEV1, FVC, and tidal expiratory flow limitation) and high dyspnea score measured by MRC reflect a decrease in exercise capacity. In a study in bronchiectasis, maximal inspiratory and maximal expiratory respiratory muscle strengths evaluated with an intraoral pressure measurement device had similar demographic characteristics. significantly lower than in healthy individuals. However, in the respiratory muscle trainings, inspiratory muscle training was emphasized and expiratory muscle training was never given.
- Conditions
- Bronchiectasis
- Being tested
- EMST150 (Expiratory muscle training), Sham EMST150 (Expiratory muscle training)
- Keywords
- Bronchiectasis, cough strength, expiratory muscle training, exercise capacity
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMST150 (Expiratory muscle training)Other
Respiratory exercise device (Expiratory muscle trainer) developed for the expiratory muscles, and resistant expiratory muscle training were applied. Threshold loading was applied to the cases at approximately 30% of the respiratory muscle strength values measured in the 1st week. In respiratory muscle training, the pressure value was increased according to the tolerance of the patient and training was given at a pressure value between 50-75%. The subjects were asked to do 10 vigorous expirations at the adjusted pressure value by doing normal inspiration for expiratory muscle training in a comfortable sitting position. This program was applied in 3 sets in the same way for approximately 30 minutes. It was continued 3 days a week for 8 weeks
Sham EMST150 (Expiratory muscle training)Other
The subjects were asked to perform normal inspiration and then exhale 10 times for expiratory muscle training without threshold loading. This program was applied in 3 sets in the same way for approximately 30 minutes. It will continue 3 days a week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| EMST (Expiratory Muscle Streght Training) group | Experimental | EMST at a pressure value between 50-75% will be applied for 8 weeks, 3 days a week and 24 sessions in total. Receives: Other: EMST150 (Expiratory muscle training) |
| Sham EMST Group | Sham comparator | EMST without threshold loading will be applied for 8 weeks, 3 days a week and 24 sessions in total. Receives: Other: Sham EMST150 (Expiratory muscle training) |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
Exercise capacity using 6-minute walk test
Measured: Baseline to 8 weeks
Cough strength
Cough strength using PEF meter
Measured: Baseline to 8 weeks
Respiratory muscle strength
Respiratory muscle strength is measured through maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using cosmed pony fx.
Measured: Baseline to 8 weeks
Secondary outcomes (4)
Leicester Cough Questionnaire
Health related quality of life is assessed with Leicester Cough Questionnaire. The total score range is 3-21 and domain scores range from 1-7; a higher score indicates a better quality of life.
Measured: Baseline to 8 weeks
Modified Medical Research Council Dyspnea Scale (MMRC)
Dyspnea severity is assessed with The Modified Medical Research Council Dyspnea Scale (MMRC).The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 4, too breathless to leave the house, or breathless when dressing or undressing.
Measured: Baseline to 8 weeks
Bronchiectasis Severity Index
Severity of disease is assessed with Bronchiectasis Severity Index. The total score is calculated by summing the scores for each variable and can range from 0 to 26 points. According to the overall score, patients are classified into three classes: patients with low BSI score (0-4 points), intermediate BSI score (5-8 points), high BSI score (≥9 points).
Measured: Baseline to 8 weeks
St. George's Respiratory Questionnaire (SGRQ)
Health related quality of life is assessed with St. George's Respiratory Questionnaire (SGRQ).SGRQ scores range from 0 to 100, with higher scores indicating worse quality of life.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Feb 2021
- Primary completion24 Sep 2022
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies 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
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşenur Yılmaz, Pamukkale University
- Investigators
- Ayşenur yılmaz, MSc Pt, Study director, Pamukkale Universityorçin telli atalay, Doç, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408455
- Sponsor's protocol ID
- 646873
- Status last verified
- Mar 2024
- First submitted
- 30 May 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Expiratory Muscle Training in Bronchiectasis Patients
- ClinicalTrials.gov ID
- NCT05408455
- Acronym / sponsor ID
- 646873
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, cough strength, expiratory muscle training, exercise capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 24 Sep 2022 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 7 Jun 2022 (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.
Reduced exercise tolerance is commonly reported in patients with bronchiectasis. The purpose of this study is to evaluate the effects of expiratory muscle training (EMT) and sham EMT (control) on exercise capacity, respiratory function and respiratory muscle strength, cough strength and health related quality of life in patients with bronchiectasis.
Detailed description
Disruption of the mucociliary clearance mechanism in patients with bronchiectasis leaves the lungs vulnerable. With the accumulation of secretions, a vicious cycle of bacterial infection and inflammation begins. Intense inflammation causes damage and bronchial wall weakness. Problems arise with effective coughing. This leads to decreased clearance of secretions, resulting in decreased expiratory flow. Symptoms of bronchiectasis; often productive cough, dyspnea, fatigue and wheezing. Altered pulmonary mechanics, inadequate gas exchange, decreased muscle mass, and accompanying psychological problems can cause dyspnea and decreased exercise capacity, thus reducing quality of life. Exercise capacity may also decrease in individuals with bronchiectasis due to increased dyspnea perception and limitation of expiratory flow. The need for safe and viable exercise interventions to reduce the burden of the disease is evident in individuals with bronchiectasis. Respiratory muscle training is applied by using skeletal muscle training principles in order to increase respiratory muscle strength and endurance, to correct the length-tension relationship of respiratory muscles and to increase respiratory capacity. Decreased expiratory muscle strength is associated with decreased quality of life and exercise tolerance. In addition, in a study, it was shown that in addition to expiratory muscle weakness, expiratory muscle endurance decreases in respiratory patients. This decrease is closely related to the severity of airway obstruction and the decrease in the strength of other muscle groups.
In order to meet the increased metabolic needs during exercise and to keep gas exchange at a sufficient level, patients with bronchiectasis; they must increase minute ventilation as appropriate. These patients with expiratory flow limitation at rest breathe at higher lung volumes to increase ventilation during exercise, and as a result, adverse conditions such as worsening of dynamic hyperinflation, increased intrinsic PEEP, increased workload on respiratory muscles and dyspnea are observed. As a result, these patients cannot achieve high levels of tidal volume and ventilation. In addition, significantly reduced maximal voluntary ventilation in patients with flow-limited bronchiectasis; It is also related to airway obstruction and mechanical deterioration. Decreased exercise capacity has also been shown to be associated with peak exercise desaturation. Those with abnormal lung mechanics (low FEV1, FVC, and tidal expiratory flow limitation) and high dyspnea score measured by MRC reflect a decrease in exercise capacity. In a study in bronchiectasis, maximal inspiratory and maximal expiratory respiratory muscle strengths evaluated with an intraoral pressure measurement device had similar demographic characteristics. significantly lower than in healthy individuals. However, in the respiratory muscle trainings, inspiratory muscle training was emphasized and expiratory muscle training was never given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMST (Expiratory Muscle Streght Training) group | Experimental | Other: EMST150 (Expiratory muscle training)EMST at a pressure value between 50-75% will be applied for 8 weeks, 3 days a week and 24 sessions in total. |
| Sham EMST Group | Sham comparator | Other: Sham EMST150 (Expiratory muscle training)EMST without threshold loading will be applied for 8 weeks, 3 days a week and 24 sessions in total. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinically stable patients who do not meet the definition of exacerbation,
- Those with a diagnosis of non-CF bronchiectasis,
- Patients are between the ages of 18-70
- Patients without acute and/or chronic respiratory failure,
- Patients who do not have any contraindications for the physiotherapy method to be applied.
Key exclusion criteria (13 listed)
- Those with a history of pneumothorax,
- Patients younger than 18 years
- Patients older than 70 years
- Presence of cor pulmonale and/or heart failure,
- Patients with hemoptysis,
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 |
|---|---|---|
| EMST150 (Expiratory muscle training)Respiratory exercise device (Expiratory muscle trainer) developed for the expiratory muscles, and resistant expiratory muscle training were applied. Threshold loading was applied to the cases at approximately 30% of the respiratory muscle strength values measured in the 1st week. In respiratory muscle training, the pressure value was increased according to the tolerance of the patient and training was given at a pressure value between 50-75%. The subjects were asked to do 10 vigorous expirations at the adjusted pressure value by doing normal inspiration for expiratory muscle training in a comfortable sitting position. This program was applied in 3 sets in the same way for approximately 30 minutes. It was continued 3 days a week for 8 weeks | Other | EMST (Expiratory Muscle Streght Training) group |
| Sham EMST150 (Expiratory muscle training)The subjects were asked to perform normal inspiration and then exhale 10 times for expiratory muscle training without threshold loading. This program was applied in 3 sets in the same way for approximately 30 minutes. It will continue 3 days a week for 8 weeks | Other | Sham EMST Group |
Primary outcome
6-minute walk test
Time frame: Baseline to 8 weeks
Exercise capacity using 6-minute walk test
Cough strength
Time frame: Baseline to 8 weeks
Cough strength using PEF meter
Respiratory muscle strength
Time frame: Baseline to 8 weeks
Respiratory muscle strength is measured through maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using cosmed pony fx.
4 secondary outcomes
Leicester Cough Questionnaire
Time frame: Baseline to 8 weeks
Modified Medical Research Council Dyspnea Scale (MMRC)
Time frame: Baseline to 8 weeks
Bronchiectasis Severity Index
Time frame: Baseline to 8 weeks
St. George's Respiratory Questionnaire (SGRQ)
Time frame: Baseline to 8 weeks
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 12 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.
Ayşenur yılmaz, MSc Pt study director
Pamukkale University
orçin telli atalay, Doç study director
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMST150 (Expiratory muscle training) in people with Bronchiectasis, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 5 inclusion and 13 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 12 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
6-minute walk test (time frame: Baseline to 8 weeks). 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 12 Mar 2024.