NCT03517839

Brief Summary

In our study, it was aimed to evaluate the effect of inspiratory muscle training on fear of movement due to dyspnea in COPD patients. Participants will be randomly assigned to two groups. Inspiratory muscle training in the training group will be administered at least 5 days a week, 15 minutes twice a day, beginning at 30% of the MIP for 8 weeks. Patients will come to the control once a week, the MIP values will be re-measured and the new training intensity will be determined at 30% of the new value. For the control group, a fixed training session will be given for at least 5 days a week, 15 minutes twice a day, not exceeding 15% of the MIP for 8 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

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

January 2, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 7, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2019

Completed
Last Updated

April 9, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

April 25, 2018

Last Update Submit

April 5, 2019

Conditions

COPD

Keywords

DyspneaInspiratory Muscle TrainingKinesiophobia

Outcome Measures

Primary Outcomes (1)

  • Breathlessness Beliefs Questionnaire-BBQ

    Breathlessness Beliefs Questionnaire-BBQ Breathlessness Perception Questionnaire; is a measure evaluating kinesophobia and anxiety due to the breathlessness of 17 questions answered by one's own practice. Patients score from 1 to 5 (I strongly agree). High scores indicate high levels of kinesiophobia and anxiety due to breathlessness.

    3 Minute (before trainig and after training)

Study Arms (2)

Training Group

EXPERIMENTAL
Other: Inspiratory muscle trainig

Control Group

SHAM COMPARATOR
Other: Inspiratory muscle trainig

Interventions

Inspiratory muscle trainigOTHER

Inspiratory muscle training in the training group will be administered at least 5 days a week, 15 minutes twice a day, beginning at 30% of the MIP for 8 weeks. Patients will come to the control once a week, the MIP values will be re-measured and the new training intensity will be determined at 30% of the new value. For the control group, a fixed training session will be given for at least 5 days a week, 15 minutes twice a day, not exceeding 15% of the MIP for 8 weeks.

Control GroupTraining Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • FEV1/FVC\<%70
  • To be able to read and understand Turkish

You may not qualify if:

  • Having undergone a COPD exacerbation in the last 6 weeks
  • Having comorbidities affecting ambulance
  • Having cognitive disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf Univercity

Istanbul, Eyalet/Yerleşke, 34350, Turkey (Türkiye)

Location

Related Publications (2)

  • De Peuter S, Janssens T, Van Diest I, Stans L, Troosters T, Decramer M, Van den Bergh O, Vlaeyen JW. Dyspnea-related anxiety: The Dutch version of the Breathlessness Beliefs Questionnaire. Chron Respir Dis. 2011;8(1):11-9. doi: 10.1177/1479972310383592. Epub 2010 Dec 20.

    PMID: 21172990RESULT

  • Beaumont M, Mialon P, Le Ber C, Le Mevel P, Peran L, Meurisse O, Morelot-Panzini C, Dion A, Couturaud F. Effects of inspiratory muscle training on dyspnoea in severe COPD patients during pulmonary rehabilitation: controlled randomised trial. Eur Respir J. 2018 Jan 25;51(1):1701107. doi: 10.1183/13993003.01107-2017. Print 2018 Jan.

    PMID: 29371379RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspneaKinesiophobia

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PT

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 7, 2018

Study Start

January 2, 2018

Primary Completion

October 25, 2018

Study Completion

January 28, 2019

Last Updated

April 9, 2019

Record last verified: 2019-02

Locations

TU(1)