Managing Dysfunctional Breathing and Exercise-induced Laryngeal Obstruction in Adolescent Athletes
Primary Purpose
Exercise Induced Laryngeal Obstruction (EILO)
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Norwegian psychomotor physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Exercise Induced Laryngeal Obstruction (EILO) focused on measuring EILO, Physiotherapy intervention, Dysfunctional breathing, Adolescent athletes, Diaphragmatic breathing, Postural alignment
Eligibility Criteria
Inclusion Criteria: Adolescent athletes with symptoms of EILO Referred to Norwegian Psychomotor Physiotherapy Exclusion Criteria: Other respiratory symptoms Additional diagnosis
Sites / Locations
- Liv-Jorunn Kolnes
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Participants with EILO were recruited and given treatment (i.e. one arm?)
Arm Description
Only participants with EILO were recruited and given treatment as usual.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06033755
First Posted
August 27, 2023
Last Updated
September 9, 2023
Sponsor
VID Specialized University
Collaborators
Norwegian School of Sport Sciences
1. Study Identification
Unique Protocol Identification Number
NCT06033755
Brief Title
Managing Dysfunctional Breathing and Exercise-induced Laryngeal Obstruction in Adolescent Athletes
Official Title
A Multidimensional Strategy to Managing Dysfunctional Breathing and Exercise-induced Laryngeal Obstruction in Adolescent Athletes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
January 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VID Specialized University
Collaborators
Norwegian School of Sport Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Induced Laryngeal Obstruction (EILO)
Keywords
EILO, Physiotherapy intervention, Dysfunctional breathing, Adolescent athletes, Diaphragmatic breathing, Postural alignment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants with EILO were recruited and given treatment (i.e. one arm?)
Arm Type
Other
Arm Description
Only participants with EILO were recruited and given treatment as usual.
Intervention Type
Other
Intervention Name(s)
Norwegian psychomotor physiotherapy
Other Intervention Name(s)
Elements of cognitive behavioural therapy, Rehabilitation plan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjective experiences of respiratory distress associated with exercise reported descriptively in an interview pre and post treatment
Description
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.
Time Frame
Five months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adolescent athletes with symptoms of EILO
Referred to Norwegian Psychomotor Physiotherapy
Exclusion Criteria:
Other respiratory symptoms
Additional diagnosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liv-Jorunn Kolnes, PhD
Organizational Affiliation
VID Specialized University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liv-Jorunn Kolnes
City
Oslo
ZIP/Postal Code
0370
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Managing Dysfunctional Breathing and Exercise-induced Laryngeal Obstruction in Adolescent Athletes
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