Feasibility of Constant Work Rate Testing to Detect Exercise-induced Laryngeal Obstruction
Study Details
Study Description
Brief Summary
TITLE Feasibility of constant work rate testing to detect exercise-induced laryngeal obstruction
DESIGN Prospective observational pilot study
AIMS To investigate if constant work rate testing at different work rates will sufficiently induce detectable exercise-induced laryngeal obstruction (EILO) using CLE.
POPULATION Adult patients with EILO
DURATION 01.09.2022 - 30.06.2023
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- prevalence and degree of glottic or supraglottic collapse in EILO patients [Changes from baseline during the procedure and immediately after cessation of the exercise test.]
Laryngoscopic detection of supraglottic or a glottic obstruction of the same severity as observed during incremental testing, during a submaximal constant work rate exercise test (70 %, 80 % and 90 %) using a visual grade scale (0-3, with 0 reflecting no obstruction, and 3 being the most severe degree of obstruction).
- Time of onset of the laryngeal obstruction [A time of onset determined during the procedures]
A specific point in time where observed laryngeal obstruction is first discernible will be determined during the evaluation of the laryngoscopic videos. This is to descriptively quantify this outcome.
- Observed duration of the laryngeal obstruction [Duration measured in seconds during the procedures]
The investigators will further evaluate the laryngoscopic videos and determine the duration of the participant's laryngeal obstruction. This duration is defined as the time period from the time of onset during submaximal exercise, until remission of the observed obstruction or end of the test.
Secondary Outcome Measures
- Patient reported symptom score: Dyspnoea-12 [At baseline]
The patients will fill out the Dyspnoea-12 questionnaire before the first exercise test The questionnaire consists of 12 questions regarding dyspnoea. This is a descriptive measure
- Patient reported symptom scores: Nijmegen [At baseline]
The participants will fill out the Nijmegen questionnaire before the first exercise test The questionnaire consists of 16 questions, with answers ranging from "never" to "very often". A score is calculated from these answers. A higher score means that it is more likely that the participant suffers from hyperventilation syndrome. This is a descriptive measure
- Patient reported symptom scores: Multidimensional Dyspnoea Profile (MDP). [At baseline]
The patients will fill out the Multidimensional Dyspnoea Profile (MDP) questionnaire before the first exercise test This profile consists of questions regarding both affective and sensory components of dyspnoea. This is a descriptive measure
- Modified borg dyspnoea during exercise [At baseline and at one minute intervals during the CLE tests (up to 60 minutes)]
Minimum score: 0 Maximum score: 10 The participant will be asked to rate dyspnoea at baseline and during the CLE tests at 1 minute intervals. The investigators will compare the scores between the incremental CLE tests and the constant work rate CLE tests.
- Leg fatigue scores during exercise [At baseline and at one minute intervals during the CLE tests (up to 60 minutes)]
Minimum score: 0 Maximum score: 10 The participant will be asked to rate leg fatigue at baseline and during the CLE tests at 1 minute intervals. The investigators will compare the scores between the incremental CLE tests and the constant work rate CLE tests.
- Rate of perceived exertion (RPE) scores during exercise [At baseline and at one minute intervals during the CLE tests (up to 60 minutes)]
Minimum score: 0 Maximum score: 10 The participant will be asked to evaluate their rate of perceived exertion at baseline and during the CLE tests at 1 minute intervals. The investigators will compare the scores between the incremental CLE tests and the constant work rate CLE tests.
- Inter-rater agreement of the prevalence and degree of glottic or supraglottic collapse in EILO patients [During data analysis (month 1).]
After obtaining laryngoscopic video data, the investigators will evaluate the severity of laryngeal obstruction using a visual grade scale (0-3). From these gradings we will calculate inter-rater agreement values (weighted kappa).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participant is willing and able to give informed consent for participation in the study.
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Male or Female, aged 18 or above with a clinical suspicion of having EILO.
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Individuals with concurrent asthma can participate in the study provided that their asthma is well-controlled, determined by a negative bronchoprovocation test.
Exclusion Criteria:
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No EILO found in Clinical standard-of-care CLE test
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Not able to complete the exercise test for other reasons than breathlessness or leg fatigue (e.g. injury, disease or disability preventing cycling to maximal exertion).
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Comorbidities other than asthma, which, judged by the investigator, might confound the test results or pose a medical risk to the patient (e.g. cardiac disease, exercise-induced anaphylaxis).
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Current smokers (< 6 months of stopping) or individuals with a significant smoking history (>10 pack years).
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Pregnancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bispebjerg Hospital | København NV | Region Hovedstaden | Denmark | 2400 |
Sponsors and Collaborators
- Bispebjerg Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-20057391