Diaphragm FatigueNCT01505517
Inspiratory Resistive Loading and Diaphragm Fatigue
An observational study of Diaphragm Fatigue and Healthy, run by KU Leuven at 1 site in Belgium.
Trial summary
The aim of the study is to clarify whether specific loading of the inspiratory muscles induces contractile fatigue of the diaphragm muscle in healthy individuals and individuals with recurrent low back pain. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Diaphragm Fatigue, Healthy, Low Back Pain
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Jun 2012
- Phase
- Observational
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: young flemish volunteers
Who may be able to join
- Age: 18-35 years old
- At least 1 year of low back pain with/without referred pain in buttock/thigh
- At least 3 episodes of disabling low back pain
- At least a score of 20% on the Oswestry Disability Index
- Willingness to sign the informed consent
- Age: 18-35 years old
Show all 9Show fewer
- No history of low back pain
- A score of 0% on the Oswestry Disability Index
- Willingness to sign the informed consent
Who cannot join
- History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant
- One of the following conditions: Parkinson, multiple sclerosis, stroke, history of vestibular disorder, respiratory disease, pregnancy
- Radicular symptoms
- Not Dutch-speaking
- Strong opioids
- Neck pain
- Smoking history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inspiratory Resistive Loading and Diaphragm Fatigue in Healthy Individuals and Individuals With Recurrent Low Back Pain
The aim of the study is to clarify whether specific loading of the inspiratory muscles induces contractile fatigue of the diaphragm muscle in healthy individuals and individuals with recurrent low back pain.
- Conditions
- Diaphragm Fatigue, Healthy, Low Back Pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| individuals with low back pain | Not described | |
| healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
transdiaphragmatic pressure
transdiaphragmatic pressure measurement in response to bilateral anterior magnetic phrenic nerve stimulation before and after an inspiratory resistive loading protocol
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startJan 2011
- Primary completionApr 2012
- Study completionJun 2012
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 Diaphragm FatigueStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Simon Brumagne, KU Leuven
- Investigators
- Simon Brumagne, PhD, Principal investigator, KU LeuvenThierry Troosters, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505517
- Sponsor's protocol ID
- 2011_SBrumagne_DiaphFatigue
- Other IDs
- 1.5.104.03, G.0674.09
- Status last verified
- Jul 2012
- First submitted
- 4 Jan 2012
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Janssens L, Brumagne S, Polspoel K, Troosters T, McConnell A. The effect of inspiratory muscles fatigue on postural control in people with and without recurrent low back pain. Spine (Phila Pa 1976). 2010 May 1;35(10):1088-94. doi: 10.1097/BRS.0b013e3181bee5c3.
PubMed 20393397Hermans G, Agten A, Testelmans D, Decramer M, Gayan-Ramirez G. Increased duration of mechanical ventilation is associated with decreased diaphragmatic force: a prospective observational study. Crit Care. 2010;14(4):R127. doi: 10.1186/cc9094. Epub 2010 Jul 1.
PubMed 20594319
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Resistive Loading and Diaphragm Fatigue in Healthy Individuals and Individuals With Recurrent Low Back Pain
- ClinicalTrials.gov ID
- NCT01505517
- Acronym / sponsor ID
- 2011_SBrumagne_DiaphFatigue
- Conditions
- Diaphragm Fatigue, Healthy, Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- Jan 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 6 Jan 2012 (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 aim of the study is to clarify whether specific loading of the inspiratory muscles induces contractile fatigue of the diaphragm muscle in healthy individuals and individuals with recurrent low back pain.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| individuals with low back pain | – | – |
| healthy controls | – | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- young flemish volunteers
Key inclusion criteria (9 listed)
- Age: 18-35 years old
- At least 1 year of low back pain with/without referred pain in buttock/thigh
- At least 3 episodes of disabling low back pain
- At least a score of 20% on the Oswestry Disability Index
- Willingness to sign the informed consent
Key exclusion criteria (7 listed)
- History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant
- One of the following conditions: Parkinson, multiple sclerosis, stroke, history of vestibular disorder, respiratory disease, pregnancy
- Radicular symptoms
- Not Dutch-speaking
- Strong opioids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
transdiaphragmatic pressure
Time frame: 18 months
transdiaphragmatic pressure measurement in response to bilateral anterior magnetic phrenic nerve stimulation before and after an inspiratory resistive loading protocol
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 5 Dec 2013.
- Background: PubMed 20393397Janssens L, Brumagne S, Polspoel K, Troosters T, McConnell A. The effect of inspiratory muscles fatigue on postural control in people with and without recurrent low back pain. Spine (Phila Pa 1976). 2010 May 1;35(10):1088-94. doi: 10.1097/BRS.0b013e3181bee5c3.
- Background: PubMed 20594319Hermans G, Agten A, Testelmans D, Decramer M, Gayan-Ramirez G. Increased duration of mechanical ventilation is associated with decreased diaphragmatic force: a prospective observational study. Crit Care. 2010;14(4):R127. doi: 10.1186/cc9094. Epub 2010 Jul 1.
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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.
Simon Brumagne, PhD principal investigator
KU Leuven
Thierry Troosters, 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?
An observational study of Diaphragm Fatigue and Healthy, 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 9 inclusion and 7 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 5 Dec 2013. 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?
transdiaphragmatic pressure (time frame: 18 months). 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 NCT01505517, 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 5 Dec 2013.