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

Not Applicable

Completed

• Conditions: Bronchiectasis
• Interventions: Device: Inspiratory muscle training group

• Registration Number: NCT02656992
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-11-20
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-15
• Primary Completion: 2017-12-25
• Study Completion: 2018-01-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-IMT group	Inspiratory muscle training 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.
Control group	Inspiratory muscle training group	Control group was prescribed at 10% of baseline maximal inspiratory pressure, and remained at this level during all training sessions for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Exercise capacity using incremental shuttle walk test and 6-minute walk test	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

Name	Time	Method
Dyspnea severity is assessed with The Modified Medical Research Council Dyspnea Scale (MMRC)	Baseline to 8 weeks
Fatigue severity is assessed with Fatigue Severity Index	Baseline to 8 weeks
Health related quality of life is assessed with Leicester Cough Questionnaire	Baseline to 8 weeks
Respiratory muscle strength	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	Baseline to 8 weeks	Respiratory muscle endurance is assessed with constant and progressive loading protocols which subjects breathe against threshold loads.
Severity of disease is assessed with Bronchiectasis Severity Index	Baseline to 8 weeks

Trial Locations

Locations (1)

Ozge Ozer; 🇹🇷 Ankara, Turkey