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
|Condition or disease||Intervention/treatment||Phase|
|Bronchiectasis||Device: Inspiratory muscle training group||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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.
- 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.
- 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.
- Health related quality of life is assessed with Leicester Cough Questionnaire [ Time Frame: Baseline to 8 weeks ]
- Dyspnea severity is assessed with The Modified Medical Research Council Dyspnea Scale (MMRC) [ Time Frame: Baseline to 8 weeks ]
- Fatigue severity is assessed with Fatigue Severity Index [ Time Frame: Baseline to 8 weeks ]
- Severity of disease is assessed with Bronchiectasis Severity Index [ Time Frame: Baseline to 8 weeks ]
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
|Ankara, Turkey, 06450|