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Pulmonary FunctionNCT07749222

Pulmonary Function, Respiratory Muscle Strength, Lung Age, Balance, And Quality Of Life In Paralympic Athletes

An observational study of Pulmonary Function and Balance, run by Halic University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Pulmonary Function, Balance, Quality of Life
How many people
24 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2024to 30 Jun 2025
Phase
Observational
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 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • İstanbul Okçular Vakfı

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation Of Pulmonary Function, Respiratory Muscle Strength, Lung Age, Balance, And Quality Of Life In Paralympic Athletes: A Cross-Sectional Study

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 months

Secondary outcomes (9)

  1. Forced vital capacity (FVC) (L)

    Pulmonary function ((Forced vital capacity (FVC )) was evaluated with a portable spirometer.

    Measured: 4 months

  2. FEV1 / FVC (%)

    Pulmonary function (FEV1 / FVC) was evaluated with a spirometer.

    Measured: 4 months

  3. Peak flow rate (PEF) (L/s)

    Pulmonary function (Peak flow rate (PEF)) was evaluated with a spirometer.

    Measured: 4 months

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

    Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)) was evaluated with a spirometer.

    Measured: 4 months

  5. Maximal expiratory pressure (MEP) (L)

    The MEP which shows respiratory muscle strength was evaluated using a portable mouth pressure measuring device based on European Respiratory Society criteria.

    Measured: 4 months

  6. Maximal inspiratory pressure (MIP) (L)

    The MIP which shows respiratory muscle strength was evaluated using a portable mouth pressure measuring device based on European Respiratory Society criteria.

    Measured: 4 months

  7. Balance

    Balance was measured using the Modified Functional Reach Test

    Measured: 4 months

  8. Quality of Life

    Quality of life was determined using the Short Form-36 (SF-36) Health Survey that contains 36 questions and produces scores for eight health related quality of life domains. Each domain is transformed to a 0-100 scale. Higher scores represents better health status while lower stores represents poor health status.

    Measured: 4 months

  9. Lung Age

    Lung age was calculated based on FEV₁ values. For male: Lung age (years)=(2.87×height in cm×0.394)-(31.25×FEV1 in L)-39.375 For females: Lung age (years)=(3.56×height in cm×0.394)-(40×FEV1 in L)-77.280

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2026
  2. Study start1 Dec 2024
  3. Primary completion31 May 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07749222
Sponsor's protocol ID
Paralympic_Athlete
Status last verified
Aug 2026
First submitted
26 Jun 2026
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Quality of life and balance results can be shared.

Publications

  • 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.

    PubMed 39411023

  • 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.

    PubMed 4070195

  • 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.

    PubMed 39593611

  • 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.

    PubMed 24326928

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Function and Balance, run by Halic University at 1 site in Turkey (Türkiye).

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 3 inclusion and 4 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 6 Aug 2026. 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 Turkey (Türkiye). 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?

Forced expiratory volume in the first second (FEV1) (L) (time frame: 4 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 NCT07749222, which also lists 4 linked publications.

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 6 Aug 2026.

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