COPDNCT03517839
Assessment of Impact of Inspiratory Muscle Training on Movement Fear Due to Dyspnea in Chronic Obstructive Pulmonary Disease
A study testing Inspiratory muscle trainig in people with COPD, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COPD
- What is being tested?
- Inspiratory muscle trainig
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2018to 28 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FEV1/FVC<%70
- To be able to read and understand Turkish
Who cannot join
- Having undergone a COPD exacerbation in the last 6 weeks
- Having comorbidities affecting ambulance
- Having cognitive disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf Univercity
Istanbul, Eyalet/Yerleşke, 34350
About this study
Official title: The Effect of Inspiratory Muscle Training on Dyspnea Related Kinesiophobia in Chronic Obstructive Pulmonary Disease
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.
Read the 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.
- Conditions
- COPD
- Being tested
- Inspiratory muscle trainig
- Keywords
- Dyspnea, Inspiratory Muscle Training, Kinesiophobia
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | Not described Receives: Other: Inspiratory muscle trainig |
| Control Group | Sham comparator | Not described Receives: Other: Inspiratory muscle trainig |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Minute (before trainig and after training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start2 Jan 2018
- Primary completion25 Oct 2018
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Saka, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517839
- Sponsor's protocol ID
- bvusska01
- Status last verified
- Feb 2019
- First submitted
- 25 Apr 2018
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21172990Beaumont 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.
PubMed 29371379
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inspiratory Muscle Training on Dyspnea Related Kinesiophobia in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03517839
- Acronym / sponsor ID
- bvusska01
- Conditions
- COPD
- Keywords
- Dyspnea, Inspiratory Muscle Training, Kinesiophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 7 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Other: Inspiratory muscle trainig |
| Control Group | Sham comparator | Other: Inspiratory muscle trainig |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- FEV1/FVC<%70
- To be able to read and understand Turkish
Key exclusion criteria (3 listed)
- Having undergone a COPD exacerbation in the last 6 weeks
- Having comorbidities affecting ambulance
- Having cognitive disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle trainigInspiratory 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. | Other | Control Group, Training Group |
Primary outcome
Breathlessness Beliefs Questionnaire-BBQ
Time frame: 3 Minute (before trainig and after training)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Results publication: PubMed 21172990De 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 publication: PubMed 29371379Beaumont 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle trainig in people with COPD, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathlessness Beliefs Questionnaire-BBQ (time frame: 3 Minute (before trainig and after training)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03517839, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.