Healthy ParticipantNCT05520216
Effect of Rib Cage and Spine Mobility on Maximum Breath-Hold Time
An observational study of Healthy Participant, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to look at the effect of rib cage and spine mobility on maximum breath holding time. To determine the relationship between spine and rib cage mobility level and respiratory capacity. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participant
- What is being tested?
- Spinal mouse (idiag m360), chest circumference measurement and Maximum Breath Hold Test
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2022to 20 Dec 2023
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: asymptomatic individual
Who may be able to join
- Being between the ages of 18-25
- Being cooperative
- Those who want to participate in the study voluntarily
Who cannot join
- Having had any lower extremity or spine surgery
- Having a vestibular system disorder
- Pregnancy or the possibility of pregnancy
- Known, diagnosed spinal cord, visceral, or other musculoskeletal disorders
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Saglik Bilimleri University
Istanbul
Duygu DEMİR, dyg.demir_17@hotmail.com
About this study
In this study, it was aimed to look at the effect of rib cage and spine mobility on maximum breath holding time. To determine the relationship between spine and rib cage mobility level and respiratory capacity.
Read the detailed description
The demographic information of the participants (gender, age, height, body weight, body mass index, occupation, dominant extremity, education level, marital status) will be questioned with the Demographic Data Form to be created by the researchers. Except for the demographic data form, the breath-holding capacity of the participants will be evaluated by measuring the breath-holding times, and the thoracic cage mobility will be evaluated by measuring the chest circumference during normal respiration, maximal inspiration and maximal expiration. The curvature of the spine, the presence of kyphosis and lordosis will be measured using the Spinal Mouse (IDIAG m360) device, which is an objective measurement method. The flexibility of the spine and indirectly the mobility of the rib cage will be checked with the sit and lie test. The results of the evaluations will be recorded.
A consent form stating that they are healthy female and male volunteer participants aged between 18-25 years old and who meet the inclusion criteria will be filled in to participate in the study. After the consent form is signed, clinical evaluations will begin.
Study Design: Experimental nonrandomized field study
- Conditions
- Healthy Participant
- Being tested
- Spinal mouse (idiag m360), chest circumference measurement, Maximum Breath Hold Test, Sit and Reach
- Keywords
- Maximum breath hold test, Spinal Mouse, Mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal mouse (idiag m360)Device
A noninvasive Spinal Mouse device will be used to measure the thoracic kyphosis and lumbar lordosis angle of the spinal column in the sagittal plane. It will be displayed on the computer aided software screen where the thoracic and lumbar region angles are calculated by swiping over the spinal processes from top to bottom with the Spinal Mouse (IDIAG m360) device. Measurements will be taken while standing on a flat surface. The volunteer will take off his upper clothes and shoes during the examination. Relax your arms and torso will be positioned next to you. The distance between the feet will be approximately waist width and parallel to each other, the knees will be straight and face motionless. He will stand where he feels comfortable. A Spinal Mouse examination will be performed and data will be recorded.
chest circumference measurementBehavioural
Measurements will be taken from the axillary (4th rib level - two fingers below the axilla), epigastric (xiphoid process level) and subcostal (9th rib level) regions at the time of normal, maximal inspiration, and maximal expiration using a tape measure while the patient is in a sitting position. The tape measure will be placed in the area to be measured. Care will be taken that there is no folding or horizontal level difference in the tape measure and that the fingers are not under the tape measure. Normal respiration will be measured first and recorded in centimeters (cm). The patient will then be asked to take a deep, long breath towards the bottom of the tape measure. The value obtained will be recorded as the deep inspiration value. Immediately after deep inspiration, the patient will be asked to make a deep and long expiration. The obtained value will be recorded as deep expiration.
Maximum Breath Hold TestBehavioural
During the breath-hold measurement, the subject will sit in a chair with a backrest. He will take a deep breath through his nose. We do not want maneuvers (Valsalva and Müller) and diaphragm contractions that will affect the breath-hold time, so volunteers will be observed throughout the test. The test will be terminated as soon as involuntary diaphragm contractions are seen. This test will be applied 3 times by resting the volunteer with breaks for 5 minutes. The average of 3 test results will be taken (Lin, Y. C.: Effect of O2 and CO2 on breath hold breaking point. In The Physiology of Breath Hold Diving. (eds): CEG Lundgren, M Ferringo, Undersea and Hyperbaric Medical Society Inc, Bethesda, Maryland, p: 75-87 1987.).
Sit and ReachBehavioural
While the participant is sitting on the floor with his back to the wall and his legs are fully extended in front of him, his knees should be in full contact with the floor. The box will be placed on the sole of the participant's feet (without shoes) in full contact with the volunteer's feet. The participant will be instructed to lean forward as slowly as possible, keeping their fingertips level with each other and their legs straight on the floor. He will be asked to slowly lie down along the ruler three times, and on the third attempt the volunteer will be instructed to reach out as far as possible and hold for 2 seconds. This value will be saved
| Study group | Role | What they receive |
|---|---|---|
| asymptomatic individuals | The demographic information of the participants (gender, age, height, body weight, body mass index, occupation, dominant extremity, education level, marital status) will be questioned with the Demographic Data Form to be created by the researchers. Except for the demographic data form, the breath-holding capacity of the participants will be evaluated by measuring the breath-holding times, and the thoracic cage mobility will be evaluated by measuring the chest circumference during normal respiration, maximal inspiration and maximal expiration. The curvature of the spine, the presence of kyphosis and lordosis will be measured using the Spinal Mouse (IDIAG m360) device, which is an objective measurement method. The flexibility of the spine and indirectly the mobility of the rib cage will be checked with the sit and lie test. The results of the evaluations will be recorded. Receives: Device: Spinal mouse (idiag m360); Behavioral: chest circumference measurement; Behavioral: Maximum Breath Hold Test; Behavioral: Sit and Reach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum breat-hold time
In conclusion, in this study, a significant relationship was found between maximum breath holding time and age, BMI, and smoking.
Measured: 20 05 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start20 Sep 2022 (estimated)
- Primary completion20 Jan 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duygu DEMİR, Principal investigator, Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520216
- Sponsor's protocol ID
- Thesis
- Other IDs
- 21/778
- Status last verified
- Jul 2022
- First submitted
- 25 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Masaki M, Ogawa Y, Inagaki Y, Sato Y, Yokota M, Maruyama S, Takeuchi M, Kasahara M, Minakawa K, Okamoto M, Chiyoda Y, Mino K, Aoyama K, Nishi T, Ando Y. Association of sagittal spinal alignment in the sitting position with the trunk and lower extremity muscle masses in children and adults with cerebral palsy: A pilot study. Clin Biomech (Bristol). 2021 Dec;90:105491. doi: 10.1016/j.clinbiomech.2021.105491. Epub 2021 Sep 25.
PubMed 34597916
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rib Cage and Spine Mobility on Maximum Breath-Hold Time
- ClinicalTrials.gov ID
- NCT05520216
- Acronym / sponsor ID
- Thesis
- Conditions
- Healthy Participant
- Keywords
- Maximum breath hold test, Spinal Mouse, Mobility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 20 Sep 2022 (estimated)
- Primary completion
- 20 Jan 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 29 Aug 2022 (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.
In this study, it was aimed to look at the effect of rib cage and spine mobility on maximum breath holding time. To determine the relationship between spine and rib cage mobility level and respiratory capacity.
Detailed description
The demographic information of the participants (gender, age, height, body weight, body mass index, occupation, dominant extremity, education level, marital status) will be questioned with the Demographic Data Form to be created by the researchers. Except for the demographic data form, the breath-holding capacity of the participants will be evaluated by measuring the breath-holding times, and the thoracic cage mobility will be evaluated by measuring the chest circumference during normal respiration, maximal inspiration and maximal expiration. The curvature of the spine, the presence of kyphosis and lordosis will be measured using the Spinal Mouse (IDIAG m360) device, which is an objective measurement method. The flexibility of the spine and indirectly the mobility of the rib cage will be checked with the sit and lie test. The results of the evaluations will be recorded.
A consent form stating that they are healthy female and male volunteer participants aged between 18-25 years old and who meet the inclusion criteria will be filled in to participate in the study. After the consent form is signed, clinical evaluations will begin.
Study Design: Experimental nonrandomized field study
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| asymptomatic individuals | – | Device: Spinal mouse (idiag m360), Behavioral: chest circumference measurement, Behavioral: Maximum Breath Hold Test, Behavioral: Sit and ReachThe demographic information of the participants (gender, age, height, body weight, body mass index, occupation, dominant extremity, education level, marital status) will be questioned with the Demographic Data Form to be created by the researchers. Except for the demographic data form, the breath-holding capacity of the participants will be evaluated by measuring the breath-holding times, and the thoracic cage mobility will be evaluated by measuring the chest circumference during normal respiration, maximal inspiration and maximal expiration. The curvature of the spine, the presence of kyphosis and lordosis will be measured using the Spinal Mouse (IDIAG m360) device, which is an objective measurement method. The flexibility of the spine and indirectly the mobility of the rib cage will be checked with the sit and lie test. The results of the evaluations will be recorded. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- asymptomatic individual
Key inclusion criteria (3 listed)
- Being between the ages of 18-25
- Being cooperative
- Those who want to participate in the study voluntarily
Key exclusion criteria (5 listed)
- Having had any lower extremity or spine surgery
- Having a vestibular system disorder
- Pregnancy or the possibility of pregnancy
- Known, diagnosed spinal cord, visceral, or other musculoskeletal disorders
- Refusal to participate in the study
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 |
|---|---|---|
| Spinal mouse (idiag m360)A noninvasive Spinal Mouse device will be used to measure the thoracic kyphosis and lumbar lordosis angle of the spinal column in the sagittal plane. It will be displayed on the computer aided software screen where the thoracic and lumbar region angles are calculated by swiping over the spinal processes from top to bottom with the Spinal Mouse (IDIAG m360) device. Measurements will be taken while standing on a flat surface. The volunteer will take off his upper clothes and shoes during the examination. Relax your arms and torso will be positioned next to you. The distance between the feet will be approximately waist width and parallel to each other, the knees will be straight and face motionless. He will stand where he feels comfortable. A Spinal Mouse examination will be performed and data will be recorded. | Device | asymptomatic individuals |
| chest circumference measurementMeasurements will be taken from the axillary (4th rib level - two fingers below the axilla), epigastric (xiphoid process level) and subcostal (9th rib level) regions at the time of normal, maximal inspiration, and maximal expiration using a tape measure while the patient is in a sitting position. The tape measure will be placed in the area to be measured. Care will be taken that there is no folding or horizontal level difference in the tape measure and that the fingers are not under the tape measure. Normal respiration will be measured first and recorded in centimeters (cm). The patient will then be asked to take a deep, long breath towards the bottom of the tape measure. The value obtained will be recorded as the deep inspiration value. Immediately after deep inspiration, the patient will be asked to make a deep and long expiration. The obtained value will be recorded as deep expiration. | Behavioural | asymptomatic individuals |
| Maximum Breath Hold TestDuring the breath-hold measurement, the subject will sit in a chair with a backrest. He will take a deep breath through his nose. We do not want maneuvers (Valsalva and Müller) and diaphragm contractions that will affect the breath-hold time, so volunteers will be observed throughout the test. The test will be terminated as soon as involuntary diaphragm contractions are seen. This test will be applied 3 times by resting the volunteer with breaks for 5 minutes. The average of 3 test results will be taken (Lin, Y. C.: Effect of O2 and CO2 on breath hold breaking point. In The Physiology of Breath Hold Diving. (eds): CEG Lundgren, M Ferringo, Undersea and Hyperbaric Medical Society Inc, Bethesda, Maryland, p: 75-87 1987.). | Behavioural | asymptomatic individuals |
| Sit and ReachWhile the participant is sitting on the floor with his back to the wall and his legs are fully extended in front of him, his knees should be in full contact with the floor. The box will be placed on the sole of the participant's feet (without shoes) in full contact with the volunteer's feet. The participant will be instructed to lean forward as slowly as possible, keeping their fingertips level with each other and their legs straight on the floor. He will be asked to slowly lie down along the ruler three times, and on the third attempt the volunteer will be instructed to reach out as far as possible and hold for 2 seconds. This value will be saved | Behavioural | asymptomatic individuals |
Primary outcome
Maximum breat-hold time
Time frame: 20 05 2022
In conclusion, in this study, a significant relationship was found between maximum breath holding time and age, BMI, and smoking.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Background: PubMed 34597916Masaki M, Ogawa Y, Inagaki Y, Sato Y, Yokota M, Maruyama S, Takeuchi M, Kasahara M, Minakawa K, Okamoto M, Chiyoda Y, Mino K, Aoyama K, Nishi T, Ando Y. Association of sagittal spinal alignment in the sitting position with the trunk and lower extremity muscle masses in children and adults with cerebral palsy: A pilot study. Clin Biomech (Bristol). 2021 Dec;90:105491. doi: 10.1016/j.clinbiomech.2021.105491. Epub 2021 Sep 25.
- 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.
Duygu DEMİR principal investigator
Saglik Bilimleri 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 Healthy Participant, run by Saglik Bilimleri Universitesi 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 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 2 Sep 2022. 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?
Contact Esra PEHLİVAN (0216 346 36 36 ext. 2615, esra.pehlivan@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum breat-hold time (time frame: 20 05 2022). 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 NCT05520216, which also lists 1 linked publication.
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 2 Sep 2022.