Feasibility of Constant Work Rate Testing to Detect Exercise-induced Laryngeal Obstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-05

Study Completion Date

2023-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Exercise-induced Laryngeal Obstruction (EILO)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Continuous laryngoscopy during exercise (CLE), incremental exercise protocol

The incremental work rate exercise test will be performed using a cycle-ergometer. The exercise protocol is initiated by a five-minute warm-up at 50 Watts (W). Subsequently, they will complete a stepwise protocol, which will begin at 100 W and increase by 2 W every 6th second, until exhaustion or until the patient is unable to continue exercise, for any reason.

Intervention Type DIAGNOSTIC_TEST

Continuous laryngoscopy during exercise (CLE), continuous work rate protocol

Within two weeks the participants will perform an additional CLE-test at various intensities. The new exercise protocol is designed to induce EILO at different exercise intensities. Using the participants' individually calculated exercise capacity, three different workloads (70 %, 80 % and 90 %) will be calculated.

The exercise protocol will be initiated with a five-minute warm-up at 50 W, then the workload will increase to the watt equivalent to 70 % of the participant's maximal exercise capacity. This workload will be fixed for ten minutes and only terminated if the participant feels the need to stop due to exhaustion or breathing difficulties. Next, the participant will have a five-minute resting phase with a set workload of 50 W. This protocol will be repeated at a workload equivalent to 80 % and 90 %

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 or above with a clinical suspicion of having EILO.
* Individuals with concurrent asthma can participate in the study provided that their asthma is well-controlled, determined by a negative bronchoprovocation test.

Exclusion Criteria

* No EILO found in Clinical standard-of-care CLE test
* 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).
* 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).
* Current smokers (\< 6 months of stopping) or individuals with a significant smoking history (\>10 pack years).
* Pregnancy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No