NCT07749222

Brief Summary

Paralympic athletes actively participate in many sports despite their physical limitations and continue to develop both individually and athletically. Assessing the physical and functional capacities of these athletes is important in terms of performance and health. This study aimed to examine the relationships between respiratory function, respiratory muscle strength, lung age, balance, and quality of life in Paralympic athletes. Additionally, it was evaluated whether there were significant differences in these parameters according to disability type and gender. The study included 24 Paralympic athletes from the disciplines of athletics, swimming, archery, and wheelchair basketball. Participants had various orthopeadic and neurological disability types, including cerebral palsy, lower extremity amputation, spinal cord injuries (C5-T6 and T7 and below), hypotonia, poliomyelitis, spina bifida, brachial plexus injury, and short stature. Respiratory function was assessed using forced vital capacity (FVC), forced expiratory volume in one second (FEV₁), FEV₁/FVC ratio, peak expiratory flow (PEF), and forced expiratory flow (FEF25-75%); respiratory muscle strength was assessed using maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). Lung age was calculated based on FEV₁ values, balance was measured using the Modified Functional Reach Test, and quality of life was determined using the Short Form (SF-36) questionnaire. Significant correlations were found between parameters. Based on the study results, supporting respiratory muscle strength in Paralympic athletes may be an important goal in rehabilitation and training programs to support respiratory function, lung age, and quality of life parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

December 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
Last Updated

August 6, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

June 26, 2026

Last Update Submit

August 1, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Forced expiratory volume in the first second (FEV1) (L)

    Pulmonary function (Forced expiratory volume in the first second FEV1)) was evaluated with a portable spirometer, COSMED Pony FX® (COSMED S.r.l., Italy) and measurements were performed according to European Respiratory Society standards. Considering that dizziness may occur during forced expiration, measurements were made while individuals were in a sitting position. While participants were sitting in a comfortable position in a chair with a backrest, nose clip was attached and they were asked to bite the mouth teeth and close their lips in a way that did not allow air to escape. The tests were performed at least 3 times by the participants and care was taken to ensure that the expiration time was at least 6 seconds and the plateau time was 1 second. Due to the device software that records all three data, it saved the average of the two best data and processed it as a value.

    4 months

Secondary Outcomes (9)

  • Forced vital capacity (FVC) (L)

    4 months

  • FEV1 / FVC (%)

    4 months

  • Peak flow rate (PEF) (L/s)

    4 months

  • Flow rate 25-75% of forced expiratory volume (FEF 25-75%) (L/s)

    4 months

  • Maximal expiratory pressure (MEP) (L)

    4 months

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Paralympic athletes who has been playing their sports minimum 1 year participated in the study.

You may qualify if:

  • Being between 18-50 years of age
  • Being registered with any of the sports federations in Turkey and being a licensed paralympic athlete for at least 1 year (
  • Having a lower extremity or upper extremity amputation or having permanent injuries as determined by the International Paralympic Committee

You may not qualify if:

  • Lack of consent to participate in the study.
  • Having undergone surgery within the last 6 months.
  • Having had a respiratory tract infection within the three weeks prior to the evaluations
  • FEV1/FVC \< 0.7

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Okçular Vakfı

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • Pinheiro L, Verhagen E, Ocarino J, Fagher K, Ahmed OH, Dalton K, Mann DL, Weiler R, Akinyi Okoth C, Blauwet CA, Lexell J, Derman W, Webborn N, Silva A, Resende R. Periodic health evaluation in Para athletes: a position statement based on expert consensus. BMJ Open Sport Exerc Med. 2024 Oct 9;10(4):e001946. doi: 10.1136/bmjsem-2024-001946. eCollection 2024.

    PMID: 39411023BACKGROUND
  • Morris JF, Temple W. Spirometric "lung age" estimation for motivating smoking cessation. Prev Med. 1985 Sep;14(5):655-62. doi: 10.1016/0091-7435(85)90085-4.

    PMID: 4070195BACKGROUND
  • Freitas JP, Costa R, Barranco LC, Reis K, Lopes AJ, Mainenti MRM, Dos Santos Vigario P. Effect of inspiratory muscle training on pulmonary function, respiratory muscle strength, aerobic performance, sports skills, and quality of life in wheelchair rugby athletes. J Bodyw Mov Ther. 2024 Oct;40:360-365. doi: 10.1016/j.jbmt.2024.04.049. Epub 2024 Apr 20.

    PMID: 39593611BACKGROUND
  • Fischer G, Tarperi C, George K, Ardigo LP. An exploratory study of respiratory muscle endurance training in high lesion level paraplegic handbike athletes. Clin J Sport Med. 2014 Jan;24(1):69-75. doi: 10.1097/JSM.0000000000000003.

    PMID: 24326928BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Proffessor

Study Record Dates

First Submitted

June 26, 2026

First Posted

August 6, 2026

Study Start

December 1, 2024

Primary Completion

May 31, 2025

Study Completion

June 30, 2025

Last Updated

August 6, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Quality of life and balance results can be shared.

Locations