- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06033755
Managing Dysfunctional Breathing and Exercise-induced Laryngeal Obstruction in Adolescent Athletes
September 9, 2023 updated by: VID Specialized University
A Multidimensional Strategy to Managing Dysfunctional Breathing and Exercise-induced Laryngeal Obstruction in Adolescent Athletes
This study aimed to assess if a multidimensional individually tailored intervention, including Norwegian Psychomotor Physiotherapy (NPMP), elements of cognitive behavioural therapy and a rehabilitation plan, helped reduce inspiratory distress and dysfunctional breathing in adolescent athletes with EILO.
A mixed methods design, which combined qualitative and quantitative research, was used.
Data, including subjective experiences of respiratory distress, findings from NPMP body examinations and objective measurements of lung function and aerobic capacity were gathered before and after a five month intervention involving 18 participants.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oslo, Norway, 0370
- Liv-Jorunn Kolnes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adolescent athletes with symptoms of EILO
- Referred to Norwegian Psychomotor Physiotherapy
Exclusion Criteria:
- Other respiratory symptoms
- Additional diagnosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Participants with EILO were recruited and given treatment (i.e. one arm?)
Only participants with EILO were recruited and given treatment as usual.
|
The intervention consisted predominantly of Norwegian Psychomotor Physiotherapy (NPMP) in which participants received individually tailored treatment based on the body examination and reported respiratory distress.
NPMP addresses bodily tension, postural de-alignments and dysfunctional breathing patterns.
The consultations also included a cognitive dimension, that is a conversation, in which thoughts and behaviours about training and competing were addressed and where participants were provided with "self help" measures that could improve breathing during training and competing.
A rehabilitation plan for each participant was designed to limit further impairments and maintaining aerobic capacity without intensifying EILO symptoms.
The intervention lasted 5 months.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective experiences of respiratory distress associated with exercise reported descriptively in an interview pre and post treatment
Time Frame: Five months
|
Experiences of respiratory distress were explored through a history taking and in an qualitative interview based on a questionnaire developed by O. Roksund (2012) Larynx in exercising humans - the unexplored bottleneck of the airways.
University of Bergen Norway (PhD thesis).
The questionnaire is not developed for research purposes, and reliability and validity studies are lacking.
It is however, functional as a basis for the pre and post interview in which respiratory distress was explored and is commonly used for the same purpose at Haukeland University hospital in Norway.
The reporting was descriptive and qualitative, and no scale or scores were used.
|
Five months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Liv-Jorunn Kolnes, PhD, VID Specialized University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 10, 2018
Primary Completion (Actual)
January 30, 2023
Study Completion (Actual)
January 30, 2023
Study Registration Dates
First Submitted
August 27, 2023
First Submitted That Met QC Criteria
September 9, 2023
First Posted (Actual)
September 13, 2023
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 9, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC 2016/1723
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The descriptive datasets concerning the body examinations generated during the study will not be publicly available du to individual privacy concerns, but will be available from the lead investigator on reasonable request.
IPD Sharing Time Frame
All statistical material will be published in the article depicting the study.
This will be submitted during august/september 2023.
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Exercise Induced Laryngeal Obstruction (EILO)
-
Haukeland University HospitalCompletedExercise Induced Laryngeal Obstruction (EILO)Norway
-
Bispebjerg HospitalRecruitingExercise-induced Laryngeal Obstruction (EILO)Denmark
-
Haukeland University HospitalRecruiting
-
Liverpool University Hospitals NHS Foundation TrustCompletedExercise-Induced Laryngeal ObstructionUnited Kingdom
-
Cook Children's Health Care SystemNot yet recruitingExercise-Induced Laryngeal Obstruction | Dyspnea During ActivityUnited States
-
Medisch Spectrum TwenteHaukeland University HospitalNot yet recruitingAsthma in Children | Larynx | Dyspnea | Exercise-Induced Bronchoconstriction | Exercise-Induced Bronchospasm | Exercise Induced Laryngeal ObstructionNetherlands
-
University of BernRecruitingCough | Asthma | Dysfunctional Breathing | Wheezing | Exercise Induced Bronchospasm | Inspiratory Laryngeal ObstructionSwitzerland, Austria
-
Indiana UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD); Purdue... and other collaboratorsRecruitingVocal Cord Dysfunction | Paradoxical Vocal Fold Motion | Exercise-Induced Vocal Cord DysfunctionUnited States
-
Appalachian State UniversityDole Food CompanyCompletedExercise-induced Inflammation | Exercise-induced Oxidative Stress | Exercise-induced Immune DysfunctionUnited States
-
Norwegian University of Science and TechnologyKlinikk for allergi og luftveissykdommerCompletedExercise Induced BronchoconstrictionNorway
Clinical Trials on Norwegian psychomotor physiotherapy
-
Tove DragesundNorwegian Fund for Postgraduate Training in PhysiotherapyCompletedPhysical DisabilityNorway
-
Vejle HospitalCompleted
-
Oslo University HospitalActive, not recruiting
-
University Hospital, GrenobleCommissariat A L'energie AtomiqueCompleted
-
Centre Hospitalier EsquirolCompleted
-
University of BergenOxford Research; Nordland Research Institute; Voksne for Barn; Bodin Upper Secondary... and other collaboratorsCompletedMental Health | Absence | Drop Out | Academic Achievement/Average Grade
-
Ostfold University CollegeYale UniversityNot yet recruiting
-
IRCCS Centro Neurolesi "Bonino-Pulejo"RecruitingGlobal Developmental DelayItaly
-
Norwegian University of Life SciencesTineCompleted
-
University of ÉvoraCompleted