NCT06957262

Brief Summary

This retrospective study aims to evaluate the effect of surgical correction of nasal obstruction on aerobic performance parameters in male athletes aged 20-32 years. The main questions it aims to answer are:

  • Does nasal obstruction surgery impact running economy and ventilation during exercise?
  • Does it affect oxygen consumption during submaximal running efforts? Researchers will retrospectively compare male athletes who underwent nasal obstruction surgery (experimental group) to matched athletes without nasal obstruction (control group) to assess changes in respiratory function and exercise performance. Participants were assessed by:
  • Acoustic rhinometry to measure nasal cavity dimensions.
  • The Nasal Obstruction Symptom Evaluation (NOSE) scale and Epworth Sleepiness Scale (ESS) to evaluate nasal obstruction symptoms and daytime sleepiness.
  • Incremental treadmill exercise tests to collect data on gas exchange, oxygen consumption, ventilation, and running economy before and after the surgical intervention (or across a similar time period for the control group).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 4, 2025

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

April 21, 2025

Last Update Submit

April 25, 2025

Conditions

Keywords

nasal surgeryaerobic performanceexercise economyrespiratory work

Outcome Measures

Primary Outcomes (1)

  • Change in Running Economy (ml/kg/min)

    Running economy was assessed via an incremental treadmill test by measuring steady-state oxygen consumption (VO₂) at submaximal running speeds (e.g., 8, 10, 12 km/h). Improvement in running economy is defined by a decrease in VO₂ at the same speed, indicating greater efficiency.

    Baseline and 2-3 months post-surgery

Secondary Outcomes (2)

  • Change in Oxygen Consumption (VO₂ max and submax VO₂)

    Baseline and 2-3 months post-surgery

  • Change in Ventilation

    Baseline and 2-3 months post-surgery

Study Arms (2)

Athletes Undergoing Septoplasty (EG)

EXPERIMENTAL

This arm included male athletes diagnosed with nasal obstruction who underwent surgical correction via septoplasty. Participants were evaluated before and approximately 2-3 months after surgery. Assessments included acoustic rhinometry to measure nasal cavity cross-sectional areas and volumes, the Epworth Sleepiness Scale (ESS), and the Nasal Obstruction Symptom Evaluation (NOSE) scale. Aerobic performance parameters such as running economy, oxygen consumption, and ventilation volume were measured using an incremental treadmill test and respiratory gas analysis.

Procedure: Surgical correction of nasal obstruction

Control Group

NO INTERVENTION

Male athletes without nasal obstruction, matched by age and training level with the experimental group. They did not receive any intervention but underwent the same aerobic performance testing protocol at the same time points for comparison.

Interventions

Surgical intervention to correct anatomical nasal obstruction, specifically septal deviation, performed under general anesthesia. The procedure involved the repositioning and reshaping of the deviated nasal septum to improve nasal airflow. The surgery was conducted by an otolaryngologist with experience in nasal airway procedures. No additional medications or postoperative interventions beyond standard care (e.g., saline irrigation, analgesics) were administered. Postoperative assessments occurred 2-3 months after surgery, including evaluations of nasal patency, sleep quality, and aerobic performance using treadmill-based gas exchange measurements.

Athletes Undergoing Septoplasty (EG)

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • For Experimental Group (EG):
  • Diagnosed with nasal obstruction due to septal deviation and/or inferior turbinate hypertrophy
  • Experiencing nasal breathing difficulties and sleep disturbance
  • Deemed eligible for septoplasty and/or inferior turbinoplasty following physical and endoscopic examination
  • Voluntarily agreed to participate in the study
  • For Control Group (CG):
  • No reported nasal obstruction or breathing complications
  • Matched with EG participants by age, sport discipline, training level, and VO₂max (with a maximum variation of ±5%)
  • Willing to follow a similar training program to their matched EG counterparts between pre- and post-testing periods

You may not qualify if:

  • History of nasal surgery
  • Presence of cardiopulmonary diseases
  • Musculoskeletal disorders affecting physical performance or exercise testing
  • Inability or unwillingness to follow the pre- and post-test training schedule
  • Any surgical complication that would interfere with post-operative participation in physical testing (note: none occurred in this study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Study Officials

  • Tuba Melekoğlu, Phd

    Akdeniz University Faculty of Sport Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This study was conducted without masking. Participants and investigators were aware of group assignments due to the nature of the intervention (surgical septoplasty). Outcome assessments (aerobic performance tests and symptom questionnaires) were conducted using objective measures and standardized procedures to minimize bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were assigned to one of two parallel groups: an experimental group consisting of athletes with nasal obstruction undergoing septoplasty, and a control group of matched athletes without nasal obstruction who did not receive any intervention. Both groups underwent the same aerobic performance evaluations at baseline and at follow-up (2-3 months).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

April 21, 2025

First Posted

May 4, 2025

Study Start

January 1, 2017

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

May 4, 2025

Record last verified: 2025-04