Clinical trial NCT02656992: Effects of High Intensity Inspiratory Muscle Training on Exercise Capacity in Patients With Bronchiectasis
Official title: Effects of High Intensity Inspiratory Muscle Training on Exercise Capacity in Patients With Bronchiectasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis
Keywords: Bronchiectasis
High-intensity inspiratory muscle training
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Exercise capacity using incremental shuttle walk test and 6-minute walk test
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: Baseline to 8 weeks
measure: Respiratory muscle endurance
timeFrame: Baseline to 8 weeks
measure: Health related quality of life is assessed with Leicester Cough Questionnaire
timeFrame: Baseline to 8 weeks
measure: Dyspnea severity is assessed with The Modified Medical Research Council Dyspnea Scale (MMRC)
timeFrame: Baseline to 8 weeks
measure: Fatigue severity is assessed with Fatigue Severity Index
timeFrame: Baseline to 8 weeks
measure: Severity of disease is assessed with Bronchiectasis Severity Index
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ozge Ozer
Study officials:
References:
citation: Ozalp O, Inal-Ince D, Cakmak A, Calik-Kutukcu E, Saglam M, Savci S, Vardar-Yagli N, Arikan H, Karakaya J, Coplu L. High-intensity inspiratory muscle training in bronchiectasis: A randomized controlled trial. Respirology. 2019 Mar;24(3):246-253. doi: 10.1111/resp.13397. Epub 2018 Sep 12.