Respiratory Muscles and Core StabilizationNCT03699566
Assessment of Trunk Muscle Endurance, Respiratory Functions and Respiratory Muscle Strength in Healthy Individuals
An observational study of Respiratory Muscles and Core Stabilization, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The diaphragm forms the upper segment of the core structure. At the same time, the diaphragm muscle acts as the first muscle in the inspiratory function. The aim of this study was to investigate the relationship between respiratory functions and trunk muscle endurance. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Respiratory Muscles and Core Stabilization
- What is being tested?
- Assessment of Respiratory Muscle Strength, Spirometer and Trunk Muscles Endurance Tests
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2017to 15 Aug 2017
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Not having any chronic disease
- Not being pregnant
Who cannot join
- History of cardiopulmonary disease.
- Morbid obesity
- Major surgical history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Trunk Muscle Endurance, Respiratory Functions and Respiratory Muscle Strength in Healthy Individuals
The diaphragm forms the upper segment of the core structure. At the same time, the diaphragm muscle acts as the first muscle in the inspiratory function. The aim of this study was to investigate the relationship between respiratory functions and trunk muscle endurance. In this context, respiratory muscle strengths, respiratory functions and body muscle endurance of the cases were measured.
Read the detailed description
The study was conducted on 60 healthy volunteers ranging in age from 20 to 36 years. 27 woman and 33 men participated in the study. Respiratory muscle strength, trunk muscle endurance, pulmonary function test values and physical activity levels were evaluated for the subjects participating in the study.Respiratory muscle strength and respiratory function tests were performed with a Cosmed Pony Fx portable spirometer. Trunk muscle endurance of the individuals were evaluated by prone bridge, side bridge, flexor endurance and sorensen test.
- Being tested
- Assessment of Respiratory Muscle Strength, Spirometer, Trunk Muscles Endurance Tests
- Keywords
- Trunk muscle endurance, respiratory muscle strength, respiratory functions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Respiratory Muscle StrengthOther
The maximal voluntary inspiratory (PImax) and expiratory (PEmax) pressure measurements of the subjects were performed using Cosmed Pony FX model (Italy 2001) while the subjects were in the sitting position with a nose clip.
SpirometerOther
Spirometric measurements were conducted with Cosmed, Pony FX (descopt spirometer- Italy 2001) spirometer using a nose clips while the subjects were in 90 degree relaxed sitting position.
Trunk Muscles Endurance TestsOther
Trunk muscle endurance of the subjects was measured using four different tests (Side Bridge Test- SBT, Prone Bridge Test- PBT, Flexor Endurance Test- FET, Sorenson Test- ST).
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Individuals aged 18-65 without chronic disease.
Interventions: Assessment of Respiratory Muscle Strength, Spirometer, Trunk Muscles Endurance Tests Receives: Other: Assessment of Respiratory Muscle Strength; Other: Spirometer; Other: Trunk Muscles Endurance Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal voluntary inspiratory (PImax)
inspiratory pressure measurement in cm H2O
Measured: Baseline assessment no follow- up
Prone Bridge Test
Trunk endurance test aganist the time
Measured: Baseline assessment no follow- up
Secondary outcomes (6)
Maximal voluntary expiratory (PEmax)
Expiratory pressure measurement in cm H2O
Measured: Baseline assessment no follow- up
Side Bride Test
Trunk endurance test aganist the time
Measured: Baseline assessment no follow- up
Forced Vital Capacity ( FVC)
Dinamic volume measure for lungs
Measured: Baseline assessment no follow- up
Forced Expiratuar Volume 1. Second ( Fev1)
Dinamic volume measure for lungs
Measured: Baseline assessment no follow- up
Abdominal Flexor Endurance Test
Trunk endurance test aganist the time
Measured: Baseline assessment no follow- up
Sorensen Test
Back Muscles endurance test aganist the time
Measured: Baseline assessment no follow- up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start10 Mar 2017
- Primary completion15 Jun 2017
- Study completion15 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Muscles and Core StabilizationStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- T.C. Dumlupınar Üniversitesi
- Responsible party
- Principal investigator, Fuat YÜKSEL, Gazi University
- Investigators
- Nevin Güzel, prof. dr., Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699566
- Sponsor's protocol ID
- Fuat1
- Status last verified
- Oct 2018
- First submitted
- 5 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Trunk Muscle Endurance, Respiratory Functions and Respiratory Muscle Strength in Healthy Individuals
- ClinicalTrials.gov ID
- NCT03699566
- Acronym / sponsor ID
- Fuat1
- Keywords
- Trunk muscle endurance, respiratory muscle strength, respiratory functions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- T.C. Dumlupınar Üniversitesi
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 9 Oct 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.
The diaphragm forms the upper segment of the core structure. At the same time, the diaphragm muscle acts as the first muscle in the inspiratory function. The aim of this study was to investigate the relationship between respiratory functions and trunk muscle endurance. In this context, respiratory muscle strengths, respiratory functions and body muscle endurance of the cases were measured.
Detailed description
The study was conducted on 60 healthy volunteers ranging in age from 20 to 36 years. 27 woman and 33 men participated in the study. Respiratory muscle strength, trunk muscle endurance, pulmonary function test values and physical activity levels were evaluated for the subjects participating in the study.Respiratory muscle strength and respiratory function tests were performed with a Cosmed Pony Fx portable spirometer. Trunk muscle endurance of the individuals were evaluated by prone bridge, side bridge, flexor endurance and sorensen test.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Other: Assessment of Respiratory Muscle Strength, Other: Spirometer, Other: Trunk Muscles Endurance TestsIndividuals aged 18-65 without chronic disease. Interventions: Assessment of Respiratory Muscle Strength, Spirometer, Trunk Muscles Endurance Tests |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (2 listed)
- Not having any chronic disease
- Not being pregnant
Key exclusion criteria (3 listed)
- History of cardiopulmonary disease.
- Morbid obesity
- Major surgical history
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 |
|---|---|---|
| Assessment of Respiratory Muscle StrengthThe maximal voluntary inspiratory (PImax) and expiratory (PEmax) pressure measurements of the subjects were performed using Cosmed Pony FX model (Italy 2001) while the subjects were in the sitting position with a nose clip. | Other | Healthy volunteers |
| SpirometerSpirometric measurements were conducted with Cosmed, Pony FX (descopt spirometer- Italy 2001) spirometer using a nose clips while the subjects were in 90 degree relaxed sitting position. | Other | Healthy volunteers |
| Trunk Muscles Endurance TestsTrunk muscle endurance of the subjects was measured using four different tests (Side Bridge Test- SBT, Prone Bridge Test- PBT, Flexor Endurance Test- FET, Sorenson Test- ST). | Other | Healthy volunteers |
Primary outcome
Maximal voluntary inspiratory (PImax)
Time frame: Baseline assessment no follow- up
inspiratory pressure measurement in cm H2O
Prone Bridge Test
Time frame: Baseline assessment no follow- up
Trunk endurance test aganist the time
6 secondary outcomes
Maximal voluntary expiratory (PEmax)
Time frame: Baseline assessment no follow- up
Side Bride Test
Time frame: Baseline assessment no follow- up
Forced Vital Capacity ( FVC)
Time frame: Baseline assessment no follow- up
Forced Expiratuar Volume 1. Second ( Fev1)
Time frame: Baseline assessment no follow- up
Abdominal Flexor Endurance Test
Time frame: Baseline assessment no follow- up
Sorensen Test
Time frame: Baseline assessment no follow- up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: Undecided
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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.
Nevin Güzel, prof. dr. study chair
Gazi University
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 Respiratory Muscles and Core Stabilization, run by Gazi 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 2 inclusion and 3 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 9 Oct 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?
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?
Maximal voluntary inspiratory (PImax) (time frame: Baseline assessment no follow- up). The study lists 2 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 9 Oct 2018.