Disabilities MultipleNCT03769480
Investigation of the Relationship Between Pulmonary Function and Muscle Strength in Athletes With Disability
An observational study of Disabilities Multiple, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
To investigate the relationship between respiratory function and core muscles strength in athletes with disabilities and compare with healthy athletes. Read more about this study
- Who is it for?
- Ages 16 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Disabilities Multiple
- What is being tested?
- Muscle strength evaluation and Respiratory function Tests
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 1 Feb 2019
- How long will I take part?
- 1 Day
- 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 16 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study group is Athletes with disabilities. The control group is the same sport branches but healthy athletes without any disabilites
Who may be able to join
- Being professional athletes for at least three years.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the relationship between respiratory function and core muscles strength in athletes with disabilities and compare with healthy athletes.
Read the 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).
- Conditions
- Disabilities Multiple
- Being tested
- Muscle strength evaluation and Respiratory function Tests
- Keywords
- Athletes, Disability, Respiratory Function, Core Muscles, Sport
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle strength evaluation and Respiratory function TestsOther
Muscle strength evaluation and Respiratory function Tests
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Study Group=Athletes with Disability Receives: Other: Muscle strength evaluation and Respiratory function Tests | |
| Control Group | Control Group=Healthy Athletes Receives: Other: Muscle strength evaluation and Respiratory function Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
FVC (the rate of normal value by the spirometer device)
Functional vital capacity: will evaluate by the rate of normal value by the spirometer device (Pony FX Cosmed device)
Measured: 2 days
FEV1 ( the rate of normal value by the spirometer device)
First second Forced Expiratory Volume:will evaluate by the rate of normal value by the spirometer device (Pony FX Cosmed device)
Measured: 2 days
Muscle strength (Abdominal Flexor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)
Abdominal Flexor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).
Measured: 2 days
Muscle strength (Abdominal Exstansor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)
Abdominal Extensor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).
Measured: 2 days
Muscle strength (Abdominal right rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)
Abdominal right rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).
Measured: 2 days
Muscle strength (Abdominal left rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)
Abdominal left rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Nov 2018
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disabilities MultipleStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bihter Aslanyurek, Ankara Yildirim Beyazıt University
- Investigators
- Tuğba Kocahan, Dr, Study chair, The Ministry of Youth and Sports, Sports General Directorship, Ankara, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769480
- Sponsor's protocol ID
- 2
- Status last verified
- Dec 2018
- First submitted
- 29 Nov 2018
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The participants all is national team. Because we can not share the data
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Pulmonary Function and Muscle Strength in Athletes With Disability
- ClinicalTrials.gov ID
- NCT03769480
- Acronym / sponsor ID
- 2
- Conditions
- Disabilities Multiple
- Keywords
- Athletes, Disability, Respiratory Function, Core Muscles, Sport
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the relationship between respiratory function and core muscles strength in athletes with disabilities and compare with healthy athletes.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Muscle strength evaluation and Respiratory function TestsStudy Group=Athletes with Disability |
| Control Group | – | Other: Muscle strength evaluation and Respiratory function TestsControl Group=Healthy Athletes |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study group is Athletes with disabilities. The control group is the same sport branches but healthy athletes without any disabilites
Key inclusion criteria (1 listed)
- Being professional athletes for at least three years.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle strength evaluation and Respiratory function TestsMuscle strength evaluation and Respiratory function Tests | Other | Control Group, Study Group |
Primary outcome
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)
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)
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).
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).
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- Individual participant dataSharing planned: No. The participants all is national team. Because we can not share the data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuğba Kocahan, Dr study chair
The Ministry of Youth and Sports, Sports General Directorship, Ankara, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disabilities Multiple, run by Ankara Yildirim Beyazıt 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Dec 2018. 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?
Results are not available in the source record.
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?
FVC (the rate of normal value by the spirometer device) (time frame: 2 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2018.