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

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ClinicalTrials.gov Identifier: NCT02656992
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ozge OZER, Hacettepe University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Device: Inspiratory muscle training group Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of High Intensity Inspiratory Muscle Training on Exercise Capacity in Patients With Bronchiectasis
Study Start Date : September 2014
Actual Primary Completion Date : December 25, 2017
Actual Study Completion Date : January 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High-IMT group
Intervention group receive supervised training sessions three times per week for 8 weeks. Each sessions lasted 21 minutes and comprised seven cycles of 2 minutes of breathing on an inspiratory threshold device followed by 1 minute of rest. High-IMT was performed at the maximal load tolerable for each 2-minute work interval and was progressively increased over the training period.
Device: Inspiratory muscle training group
Sham Comparator: Control group
Control group was prescribed at 10% of baseline maximal inspiratory pressure, and remained at this level during all training sessions for 8 weeks.
Device: Inspiratory muscle training group



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656992


Locations
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Turkey
Ozge Ozer
Ankara, Turkey, 06450
Sponsors and Collaborators
Hacettepe University

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Responsible Party: Ozge OZER, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT02656992     History of Changes
Other Study ID Numbers: GO 13/292
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018

Keywords provided by Ozge OZER, Hacettepe University:
Bronchiectasis
High-intensity inspiratory muscle training

Additional relevant MeSH terms:
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Respiratory Aspiration
Bronchiectasis
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases