Chronic Obstructive Pulmonary DiseaseNCT02186340
Effects of Inspiratory Muscle Training on Breathing Pattern in Patients With Chronic Obstructive Pulmonary Disease
A study testing Inspiratory muscle training in people with Chronic Obstructive Pulmonary Disease and Muscle Weakness Conditions, run by KU Leuven at 1 site in Belgium.
Trial summary
The improvement in inspiratory muscle function might result in beneficial changes in breathing pattern during whole body exercise. The hypothesis is the effect of inspiratory muscle training as an adjunct to a pulmonary rehabilitation program improves the breathing pattern during an incremental cycle exercise. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Muscle Weakness Conditions
- What is being tested?
- Inspiratory muscle training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2013to Jul 2015
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically stable COPD patients
- maximal inspiratory pressure <100% of the predicted normal value
Who cannot join
- Major comorbidities preventing successful participation in an 8 week exercise training intervention
Trial locations and contacts
1 site in 1 country.
About this study
The improvement in inspiratory muscle function might result in beneficial changes in breathing pattern during whole body exercise. The hypothesis is the effect of inspiratory muscle training as an adjunct to a pulmonary rehabilitation program improves the breathing pattern during an incremental cycle exercise.
- Being tested
- Inspiratory muscle training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training | Experimental | Not described Receives: Procedure: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breathing pattern during an incremental cycle exercise test
At comparable levels of ventilation breathing frequency, inspiratory time (Ti), expiratory time (Te), total time of the respiratory cycle (Ttot), inspiratory duty cycle (Ti/Ttot), and inspiratory flow rates will be compared.
Measured: Baseline and 8 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJan 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Langer, KU Leuven
- Investigators
- Rik PT Gosselink, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186340
- Sponsor's protocol ID
- S52852-2
- Status last verified
- Aug 2015
- First submitted
- 3 Jul 2014
- Last updated
- 31 Aug 2015
- Results posted
- No
Publications
Charususin N, Gosselink R, McConnell A, Demeyer H, Topalovic M, Decramer M, Langer D. Inspiratory muscle training improves breathing pattern during exercise in COPD patients. Eur Respir J. 2016 Apr;47(4):1261-4. doi: 10.1183/13993003.01574-2015. Epub 2016 Feb 25. No abstract available.
PubMed 26917617
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training on Breathing Pattern in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02186340
- Acronym / sponsor ID
- S52852-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Jul 2014 (estimated)
- 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.
The improvement in inspiratory muscle function might result in beneficial changes in breathing pattern during whole body exercise. The hypothesis is the effect of inspiratory muscle training as an adjunct to a pulmonary rehabilitation program improves the breathing pattern during an incremental cycle exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training | Experimental | Procedure: Inspiratory muscle training |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically stable COPD patients
- maximal inspiratory pressure <100% of the predicted normal value
Key exclusion criteria (1 listed)
- Major comorbidities preventing successful participation in an 8 week exercise training intervention
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 training | Procedure or surgery | Inspiratory muscle training |
Primary outcome
Change in breathing pattern during an incremental cycle exercise test
Time frame: Baseline and 8 weeks follow-up
At comparable levels of ventilation breathing frequency, inspiratory time (Ti), expiratory time (Te), total time of the respiratory cycle (Ttot), inspiratory duty cycle (Ti/Ttot), and inspiratory flow rates will be compared.
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 31 Aug 2015.
- Derived from this study: PubMed 26917617Charususin N, Gosselink R, McConnell A, Demeyer H, Topalovic M, Decramer M, Langer D. Inspiratory muscle training improves breathing pattern during exercise in COPD patients. Eur Respir J. 2016 Apr;47(4):1261-4. doi: 10.1183/13993003.01574-2015. Epub 2016 Feb 25. No abstract available.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Rik PT Gosselink, PhD principal investigator
KU Leuven
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 training in people with Chronic Obstructive Pulmonary Disease and Muscle Weakness Conditions, run by KU Leuven at 1 site in Belgium.
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 1 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 31 Aug 2015. 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 Belgium. 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. 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?
Change in breathing pattern during an incremental cycle exercise test (time frame: Baseline and 8 weeks follow-up). 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 NCT02186340, which also lists 1 linked publication.
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 31 Aug 2015.