Expiratory Muscle Training in Bronchiectasis

Bronchiectasis Clinical Trial

Official title:

Effect of Expiratory Muscle Training in Bronchiectasis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05408455
• Other study ID #: 646873
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: January 23, 2023

Study information

• Verified date: March 2024
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 in patients with bronchiectasis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 23, 2023
• Est. primary completion date: September 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute walk test	Exercise capacity using 6-minute walk test	Baseline to 8 weeks
Primary	Cough strength	Cough strength using PEF meter	Baseline to 8 weeks
Primary	Respiratory muscle strength	Respiratory muscle strength is measured through maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using cosmed pony fx.	Baseline to 8 weeks
Secondary	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.	Baseline to 8 weeks
Secondary	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.	Baseline to 8 weeks
Secondary	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).	Baseline to 8 weeks
Secondary	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.	Baseline to 8 weeks