NCT02656992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2017

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2018

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

3.3 years

First QC Date

November 20, 2015

Last Update Submit

August 2, 2018

Conditions

Bronchiectasis

Keywords

BronchiectasisHigh-intensity inspiratory muscle training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Respiratory muscle strength

    Baseline to 8 weeks

  • Respiratory muscle endurance

    Baseline to 8 weeks

  • Health related quality of life is assessed with Leicester Cough Questionnaire

    Baseline to 8 weeks

  • 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

  • +1 more secondary outcomes

Study Arms (2)

High-IMT group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Interventions

Inspiratory muscle training groupDEVICE
Control groupHigh-IMT group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of bronchiectasis with high resolution computed tomography
  • being 18-65 years of age
  • being able to walk and co-operate

You may not qualify if:

  • acute exacerbation or change in drugs or usage of antibiotics in last 3 weeks
  • neurological disease, severe orthopaedic problem or advanced heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozge Ozer

Ankara, 06450, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 30209855DERIVED

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2015

First Posted

January 15, 2016

Study Start

September 1, 2014

Primary Completion

December 25, 2017

Study Completion

January 5, 2018

Last Updated

August 3, 2018

Record last verified: 2018-08

Locations

TU(1)