Expiratory Muscle Training in Bronchiectasis

NCT05408455 | Completed

• 1 other identifier: 646873
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Keywords

Bronchiectasis; cough strength; expiratory muscle training; exercise capacity

Outcome Measures

Primary Outcomes (3)

• 6-minute walk test

  Exercise capacity using 6-minute walk test

  Baseline to 8 weeks

• Cough strength

  Cough strength using PEF meter

  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.

  Baseline to 8 weeks

Secondary Outcomes (4)

• Leicester Cough Questionnaire

  Baseline to 8 weeks

• Modified Medical Research Council Dyspnea Scale (MMRC)

  Baseline to 8 weeks

• Bronchiectasis Severity Index

  Baseline to 8 weeks

• St. George's Respiratory Questionnaire (SGRQ)

  Baseline to 8 weeks

Study Arms (2)

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.

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.

Other: Sham EMST150 (Expiratory muscle training)

Interventions

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

EMST (Expiratory Muscle Streght Training) group

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

Sham EMST Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, 20020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Ayşenur yılmaz, MSc Pt

  Pamukkale University

  STUDY DIRECTOR

• orçin telli atalay, Doç

  Pamukkale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Pt

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 7, 2022
• Study Start: February 1, 2021
• Primary Completion: September 24, 2022
• Study Completion: January 23, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)