search
Back to results

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

Primary Purpose

Bronchiectasis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inspiratory muscle training group
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Bronchiectasis, High-intensity inspiratory muscle training

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ozge Ozer

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

High-IMT group

Control group

Arm Description

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 was prescribed at 10% of baseline maximal inspiratory pressure, and remained at this level during all training sessions for 8 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Respiratory muscle strength
Respiratory muscle strength is measured through maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using a handheld device.
Respiratory muscle endurance
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
Dyspnea severity is assessed with The Modified Medical Research Council Dyspnea Scale (MMRC)
Fatigue severity is assessed with Fatigue Severity Index
Severity of disease is assessed with Bronchiectasis Severity Index

Full Information

First Posted
November 20, 2015
Last Updated
August 2, 2018
Sponsor
Hacettepe University
search

1. Study Identification

Unique Protocol Identification Number
NCT02656992
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 25, 2017 (Actual)
Study Completion Date
January 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Bronchiectasis, High-intensity inspiratory muscle training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-IMT group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Control group was prescribed at 10% of baseline maximal inspiratory pressure, and remained at this level during all training sessions for 8 weeks.
Intervention Type
Device
Intervention Name(s)
Inspiratory muscle training group
Primary Outcome Measure Information:
Title
Exercise capacity using incremental shuttle walk test and 6-minute walk test
Description
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.
Time Frame
Baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Respiratory muscle strength
Description
Respiratory muscle strength is measured through maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using a handheld device.
Time Frame
Baseline to 8 weeks
Title
Respiratory muscle endurance
Description
Respiratory muscle endurance is assessed with constant and progressive loading protocols which subjects breathe against threshold loads.
Time Frame
Baseline to 8 weeks
Title
Health related quality of life is assessed with Leicester Cough Questionnaire
Time Frame
Baseline to 8 weeks
Title
Dyspnea severity is assessed with The Modified Medical Research Council Dyspnea Scale (MMRC)
Time Frame
Baseline to 8 weeks
Title
Fatigue severity is assessed with Fatigue Severity Index
Time Frame
Baseline to 8 weeks
Title
Severity of disease is assessed with Bronchiectasis Severity Index
Time Frame
Baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Ozge Ozer
City
Ankara
ZIP/Postal Code
06450
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
30209855
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs