Clinical trial NCT05408455: Expiratory Muscle Training in Bronchiectasis
Official title: Effect of Expiratory Muscle Training in Bronchiectasis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis
Keywords: Bronchiectasis
cough strength
expiratory muscle training
exercise capacity
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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,
* 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

Primary outcomes:
measure: 6-minute walk test
timeFrame: Baseline to 8 weeks
measure: Cough strength
timeFrame: Baseline to 8 weeks
measure: Respiratory muscle strength
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Leicester Cough Questionnaire
timeFrame: Baseline to 8 weeks
measure: Modified Medical Research Council Dyspnea Scale (MMRC)
timeFrame: Baseline to 8 weeks
measure: Bronchiectasis Severity Index
timeFrame: Baseline to 8 weeks
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Ayşenur yılmaz, MSc Pt
role: STUDY_DIRECTOR
affiliation: Pamukkale University
name: orçin telli atalay, Doç
role: STUDY_DIRECTOR
References: