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Completed

NCT Number: NCT02656992

Effects of High Intensity Inspiratory Muscle Training on Exercise Capacity in Patients With Bronchiectasis

Reduced exercise tolerance is commonly reported in patients with bronchiectasis. The purpose of this study is to evaluate the effects of high-intensity inspiratory muscle training (High-IMT) and sham High-IMT (control) on exercise capacity, respiratory muscle function (strength and endurance) and health related quality of life in patients with bronchiectasis.

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ozge Ozer

Ankara, 06450, Turkey (Türkiye)

About this study

Bronchiectasis often demonstrates decreased exercise tolerance, marked dyspnea and fatigue. The causes are multifactorial and include altered pulmonary mechanics, inefficient gas exchange, decreased muscle mass, and psychological status, which all lead to a progressive detraining effect. Essentially both the pathology and the functional manifestations of bronchiectasis increase the demand for inspiratory muscle work and that contribute to dyspnea and exercise limitation.

In recent studies reduced strength of respiratory muscles are investigated in bronchiectasis and can be contribute the exercise limitation. Additionally IMT has shown to improve respiratory muscle function, exercise tolerance and dyspnea in patients with bronchiectasis. Despite this, the number of studies are inadequate and so the optimal training protocol remains still to be defined. In this study the researchers want to investigate the effects of high-intensity inspiratory muscle training in functional results in patients with bronchiectasis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of bronchiectasis with high resolution computed tomography
  • being 18-65 years of age
  • being able to walk and co-operate

Exclusion criteria

  • acute exacerbation or change in drugs or usage of antibiotics in last 3 weeks
  • neurological disease, severe orthopaedic problem or advanced heart failure

Treatment and study plan

Inspiratory muscle training group

Device

Primary outcomes

  1. Exercise capacity using incremental shuttle walk test and 6-minute walk test

    Time frame: Baseline to 8 weeks

    • The incremental shuttle walk test will be performed in an enclosed corridor. Patients are required to walk back and forth, turning around two cones placed 9 meters apart making the shuttle distance 10 meters long. Patients will follow the rhythm dictated by the audio signal.
    • 6-minute walk test will be performed in a long, straight, enclosed corridor 30 meters in length. Patients are required to walk in their walking speed with standardised instructions. The distance walked by subjects during 6 minutes will be recorded.

Secondary outcomes

  1. 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 a handheld device.

  2. Respiratory muscle endurance

    Time frame: Baseline to 8 weeks

    Respiratory muscle endurance is assessed with constant and progressive loading protocols which subjects breathe against threshold loads.

  3. Health related quality of life is assessed with Leicester Cough Questionnaire

    Time frame: Baseline to 8 weeks

  4. Dyspnea severity is assessed with The Modified Medical Research Council Dyspnea Scale (MMRC)

    Time frame: Baseline to 8 weeks

  5. Fatigue severity is assessed with Fatigue Severity Index

    Time frame: Baseline to 8 weeks

  6. Severity of disease is assessed with Bronchiectasis Severity Index

    Time frame: Baseline to 8 weeks

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jan 15, 2016
Registry last updated
Aug 3, 2018

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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