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Completed

NCT Number: NCT05408455

Expiratory Muscle Training in Bronchiectasis

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, 20020, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 6-minute walk test

    Time frame: Baseline to 8 weeks

    Exercise capacity using 6-minute walk test

  2. Cough strength

    Time frame: Baseline to 8 weeks

    Cough strength using PEF meter

  3. 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.

Secondary outcomes

  1. Leicester Cough Questionnaire

    Time frame: Baseline to 8 weeks

    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.

  2. Modified Medical Research Council Dyspnea Scale (MMRC)

    Time frame: Baseline to 8 weeks

    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.

  3. Bronchiectasis Severity Index

    Time frame: Baseline to 8 weeks

    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).

  4. St. George's Respiratory Questionnaire (SGRQ)

    Time frame: Baseline to 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Effect of Expiratory Muscle Training in Bronchiectasis Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 7, 2022
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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