Investigation of the Relationship Between Pulmonary Function and Muscle Strength in Athletes With Disability

December 7, 2018 updated by: Bihter Aslanyurek, Ankara Yildirim Beyazıt University
To investigate the relationship between respiratory function and core muscles strength in athletes with disabilities and compare with healthy athletes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The determination of parameters affecting the performance of high performance athletes that are effective in performance is very important to determine the physical performance potential. The body is a kinetic chain and core muscles play an important role in this chain. The relationship between the performance ability of the athletes and the relationship between the core muscles and performance abilities and respiratory function is extremely important. Different functional classifications caused by different barriers (physical, mental or visual) in many paralympic branches affect physical training because it is directly related to the classification, performance and training adaptations of an athlete. Determining the parameters that affect the respiratory function of paralympics is very important to develop a training program with strategies that can affect the physical performance of athletes and thus to achieve the desired results in training and competitions. Therefore, the aim of this study was to investigate the relationship between respiratory muscle strength and core muscle strength in paralympic athletes (athletes with disability).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Bihter Akınoğlu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study group is Athletes with disabilities.

The control group is the same sport branches but healthy athletes without any disabilites

Description

Inclusion Criteria:

  • Being professional athletes for at least three years.

Exclusion Criteria:

  • Having any lumbar injuries in the last three months,
  • Having systemic problems other than their disabilities(for athletes with disabilities),
  • Having any disability related to vision and hearing,
  • Acute or chronic respiratory infection,
  • Spinal cord injury level up to the innervation of the abdominal muscles (for paraplegic athletes).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Study Group
Study Group=Athletes with Disability
Other: Muscle strength evaluation and Respiratory function Tests
Muscle strength evaluation and Respiratory function Tests
Control Group
Control Group=Healthy Athletes
Other: Muscle strength evaluation and Respiratory function Tests
Muscle strength evaluation and Respiratory function Tests

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
FVC (the rate of normal value by the spirometer device)
Time Frame: 2 days
Functional vital capacity: will evaluate by the rate of normal value by the spirometer device (Pony FX Cosmed device)
2 days
FEV1 ( the rate of normal value by the spirometer device)
Time Frame: 2 days
First second Forced Expiratory Volume:will evaluate by the rate of normal value by the spirometer device (Pony FX Cosmed device)
2 days
Muscle strength (Abdominal Flexor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)
Time Frame: 2 days
Abdominal Flexor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).
2 days
Muscle strength (Abdominal Exstansor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)
Time Frame: 2 days
Abdominal Extensor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).
2 days
Muscle strength (Abdominal right rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)
Time Frame: 2 days
Abdominal right rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).
2 days
Muscle strength (Abdominal left rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)
Time Frame: 2 days
Abdominal left rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Yildirim Beyazıt University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Tuğba Kocahan, Dr, The Ministry of Youth and Sports, Sports General Directorship, Ankara, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2 (Instituto Cardiovascular de Buenos Aires)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The participants all is national team. Because we can not share the data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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