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Assessment of Impact of Inspiratory Muscle Training on Movement Fear Due to Dyspnea in Chronic Obstructive Pulmonary Disease

Primary Purpose

COPD

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inspiratory muscle trainig
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for COPD focused on measuring Dyspnea, Inspiratory Muscle Training, Kinesiophobia

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Bezmialem Vakıf Univercity

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Training Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 25, 2018
Last Updated
April 5, 2019
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT03517839
Brief Title
Assessment of Impact of Inspiratory Muscle Training on Movement Fear Due to Dyspnea in Chronic Obstructive Pulmonary Disease
Official Title
The Effect of Inspiratory Muscle Training on Dyspnea Related Kinesiophobia in Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
October 25, 2018 (Actual)
Study Completion Date
January 28, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Pulmonary diseases are a common cause of mortality and morbidity worldwide. Chronic Obstructive Pulmonary Disease (COPD) causes respiratory muscle weakness, but also causes hypercapnia, dyspnoea, oxygen desaturation, and gait disturbances. In COPD, the main symptom is dyspnea and leads to activity limitation. It has been shown that with exercise, the diaphragm workload increases in COPD patients and requires more MIP than healthy humans. This is associated with dyspnea during exercise and tiredness in the respiratory muscles. Dyspnea is defined as the difficulty in breathing of a person. Painful situations are defined as 'kinesiophobia' as a result of physical injuries and fear of repetition of the problem as a result of injury. Similarly, COPD patients avoid themselves from dyspnea-related activities or compensate by reducing the rate of activity. This reduces the severity of the symptom that precedes the symptom that may occur. As a result, fear of movement occurs due to dyspnea. Decrease in the level of activity; social isolation, fear of dyspnea, depression and anxiety result in a stubborn cycle, reducing the quality of life. In order to increase respiratory muscle strength and endurance, to improve the length tension relationship of respiratory muscles and to increase respiratory capacity, respiratory muscle training is performed by using the training principle of skeletal muscles. In COPD, inspiratory muscle training has been shown in many studies to reduce dyspnoea perception, increase exercise capacity and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
Dyspnea, Inspiratory Muscle Training, Kinesiophobia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle trainig
Intervention Description
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.
Primary Outcome Measure Information:
Title
Breathlessness Beliefs Questionnaire-BBQ
Description
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.
Time Frame
3 Minute (before trainig and after training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: FEV1/FVC<%70 To be able to read and understand Turkish Exclusion Criteria: Having undergone a COPD exacerbation in the last 6 weeks Having comorbidities affecting ambulance Having cognitive disorders
Facility Information:
Facility Name
Bezmialem Vakıf Univercity
City
Istanbul
State/Province
Eyalet/Yerleşke
ZIP/Postal Code
34350
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21172990
Citation
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.
Results Reference
result
PubMed Identifier
29371379
Citation
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.
Results Reference
result

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Assessment of Impact of Inspiratory Muscle Training on Movement Fear Due to Dyspnea in Chronic Obstructive Pulmonary Disease

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