Exercise Induced Laryngeal Obstruction (EILO)NCT06033755
Managing Dysfunctional Breathing and Exercise-induced Laryngeal Obstruction in Adolescent Athletes
A study testing Norwegian psychomotor physiotherapy in people with Exercise Induced Laryngeal Obstruction (EILO), run by VID Specialized University at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Exercise Induced Laryngeal Obstruction (EILO)
- What is being tested?
- Norwegian psychomotor physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNorway
- Study dates
- 10 Dec 2018to 30 Jan 2023
- 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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent athletes with symptoms of EILO
- Referred to Norwegian Psychomotor Physiotherapy
Who cannot join
- Other respiratory symptoms
- Additional diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Norwegian psychomotor physiotherapy
- Keywords
- EILO, Physiotherapy intervention, Dysfunctional breathing, Adolescent athletes, Diaphragmatic breathing, Postural alignment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norwegian psychomotor physiotherapyOther
Also called Elements of cognitive behavioural therapy, Rehabilitation plan
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with EILO were recruited and given treatment (i.e. one arm?) | Other | Only participants with EILO were recruited and given treatment as usual. Receives: Other: Norwegian psychomotor physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective experiences of respiratory distress associated with exercise reported descriptively in an interview pre and post treatment
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.
Measured: Five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start10 Dec 2018
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
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 Exercise Induced Laryngeal Obstruction (EILO)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A mixed methods design, which combined qualitative and quantitative research, was used. Data, including subjective experiences of respiratory distress, findings from physiotherapeutic body examinations and objective measurements of lung function and aerobic capacity were gathered before and after a five month intervention.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- VID Specialized University
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Responsible party
- Sponsor
- Investigators
- Liv-Jorunn Kolnes, PhD, Principal investigator, VID Specialized University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033755
- Sponsor's protocol ID
- REC 2016/1723
- Status last verified
- Sep 2023
- First submitted
- 27 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Kolnes LJ, Stensrud T, Andersen OK. A multidimensional strategy to managing dysfunctional breathing and exercise-induced laryngeal obstruction in adolescent athletes. BMC Sports Sci Med Rehabil. 2024 Jan 11;16(1):13. doi: 10.1186/s13102-023-00804-2.
PubMed 38212851
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidimensional Strategy to Managing Dysfunctional Breathing and Exercise-induced Laryngeal Obstruction in Adolescent Athletes
- ClinicalTrials.gov ID
- NCT06033755
- Acronym / sponsor ID
- REC 2016/1723
- Keywords
- EILO, Physiotherapy intervention, Dysfunctional breathing, Adolescent athletes, Diaphragmatic breathing, Postural alignment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- VID Specialized UniversityUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 13 Sep 2023 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A mixed methods design, which combined qualitative and quantitative research, was used. Data, including subjective experiences of respiratory distress, findings from physiotherapeutic body examinations and objective measurements of lung function and aerobic capacity were gathered before and after a five month intervention.
| Arm | Type | Receives |
|---|---|---|
| Participants with EILO were recruited and given treatment (i.e. one arm?) | Other | Other: Norwegian psychomotor physiotherapyOnly participants with EILO were recruited and given treatment as usual. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Adolescent athletes with symptoms of EILO
- Referred to Norwegian Psychomotor Physiotherapy
Key exclusion criteria (2 listed)
- Other respiratory symptoms
- Additional diagnosis
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 |
|---|---|---|
| Norwegian psychomotor physiotherapyAlso: Elements of cognitive behavioural therapy, Rehabilitation planThe 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 | Participants with EILO were recruited and given treatment (i.e. one arm?) |
Primary outcome
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.
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 13 Sep 2023.
- Derived from this study: PubMed 38212851Kolnes LJ, Stensrud T, Andersen OK. A multidimensional strategy to managing dysfunctional breathing and exercise-induced laryngeal obstruction in adolescent athletes. BMC Sports Sci Med Rehabil. 2024 Jan 11;16(1):13. doi: 10.1186/s13102-023-00804-2.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Exercise Induced Laryngeal Obstruction (EILO)
Recruiting
HelpILO - RCT on EILO Treatment
Exercise Induced Laryngeal Obstruction (EILO)
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.
Liv-Jorunn Kolnes, PhD principal investigator
VID Specialized University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norwegian psychomotor physiotherapy in people with Exercise Induced Laryngeal Obstruction (EILO), run by VID Specialized University at 1 site in Norway.
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 2 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 13 Sep 2023. 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 Norway. 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?
Subjective experiences of respiratory distress associated with exercise reported descriptively in an interview pre and post treatment (time frame: Five 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 NCT06033755, 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 13 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.