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Expiratory Muscle Training in Bronchiectasis

Primary Purpose

Bronchiectasis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
EMST150 (Expiratory muscle training)
Sham EMST150 (Expiratory muscle training)
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Bronchiectasis, cough strength, expiratory muscle training, exercise capacity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

EMST (Expiratory Muscle Streght Training) group

Sham EMST Group

Arm Description

EMST at a pressure value between 50-75% will be applied for 8 weeks, 3 days a week and 24 sessions in total.

EMST without threshold loading will be applied for 8 weeks, 3 days a week and 24 sessions in total.

Outcomes

Primary Outcome Measures

6-minute walk test
Exercise capacity using 6-minute walk test
Cough strength
Cough strength using PEF meter
Respiratory muscle strength
Respiratory muscle strength is measured through maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using cosmed pony fx.

Secondary Outcome Measures

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.
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.
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).
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.

Full Information

First Posted
May 30, 2022
Last Updated
July 12, 2023
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT05408455
Brief Title
Expiratory Muscle Training in Bronchiectasis
Official Title
Effect of Expiratory Muscle Training in Bronchiectasis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Bronchiectasis, cough strength, expiratory muscle training, exercise capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMST (Expiratory Muscle Streght Training) group
Arm Type
Experimental
Arm Description
EMST at a pressure value between 50-75% will be applied for 8 weeks, 3 days a week and 24 sessions in total.
Arm Title
Sham EMST Group
Arm Type
Sham Comparator
Arm Description
EMST without threshold loading will be applied for 8 weeks, 3 days a week and 24 sessions in total.
Intervention Type
Other
Intervention Name(s)
EMST150 (Expiratory muscle training)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Sham EMST150 (Expiratory muscle training)
Intervention Description
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 Outcome Measure Information:
Title
6-minute walk test
Description
Exercise capacity using 6-minute walk test
Time Frame
Baseline to 8 weeks
Title
Cough strength
Description
Cough strength using PEF meter
Time Frame
Baseline to 8 weeks
Title
Respiratory muscle strength
Description
Respiratory muscle strength is measured through maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using cosmed pony fx.
Time Frame
Baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Leicester Cough Questionnaire
Description
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.
Time Frame
Baseline to 8 weeks
Title
Modified Medical Research Council Dyspnea Scale (MMRC)
Description
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.
Time Frame
Baseline to 8 weeks
Title
Bronchiectasis Severity Index
Description
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).
Time Frame
Baseline to 8 weeks
Title
St. George's Respiratory Questionnaire (SGRQ)
Description
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.
Time Frame
Baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşenur yılmaz, MSc Pt
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
orçin telli atalay, Doç
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
20020
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Expiratory Muscle Training in Bronchiectasis

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