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

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656992
• Other study ID #: GO 13/292
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: January 5, 2018

Study information

• Verified date: August 2018
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 5, 2018
• Est. primary completion date: December 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis
• Respiratory Aspiration

Intervention

Device:
• Inspiratory muscle training group

Locations

Country	Name	City	State
Turkey	Ozge Ozer	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity using incremental shuttle walk test and 6-minute walk test	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.	Baseline to 8 weeks
Secondary	Respiratory muscle strength	Respiratory muscle strength is measured through maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using a handheld device.	Baseline to 8 weeks
Secondary	Respiratory muscle endurance	Respiratory muscle endurance is assessed with constant and progressive loading protocols which subjects breathe against threshold loads.	Baseline to 8 weeks
Secondary	Health related quality of life is assessed with Leicester Cough Questionnaire		Baseline to 8 weeks
Secondary	Dyspnea severity is assessed with The Modified Medical Research Council Dyspnea Scale (MMRC)		Baseline to 8 weeks
Secondary	Fatigue severity is assessed with Fatigue Severity Index		Baseline to 8 weeks
Secondary	Severity of disease is assessed with Bronchiectasis Severity Index		Baseline to 8 weeks