NCT05520216

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

September 2, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

August 25, 2022

Last Update Submit

August 31, 2022

Conditions

Keywords

Maximum breath hold testSpinal MouseMobility

Outcome Measures

Primary Outcomes (1)

  • Maximum breat-hold time

    In conclusion, in this study, a significant relationship was found between maximum breath holding time and age, BMI, and smoking.

    20 05 2022

Study Arms (1)

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.

Device: Spinal mouse (idiag m360)Behavioral: chest circumference measurementBehavioral: Maximum Breath Hold TestBehavioral: Sit and Reach

Interventions

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.

asymptomatic individuals

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.

asymptomatic individuals

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.).

asymptomatic individuals
Sit and ReachBEHAVIORAL

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

asymptomatic individuals

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

asymptomatic individual

You may qualify if:

  • Being between the ages of 18-25
  • Being cooperative
  • Those who want to participate in the study voluntarily

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saglik Bilimleri University

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34597916BACKGROUND

MeSH Terms

Interventions

4-Acetamido-4'-isothiocyanatostilbene-2,2'-disulfonic Acid

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsIsothiocyanatesIsocyanatesSulfur Compounds

Study Officials

  • Duygu DEMİR

    Saglik Bilimleri University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2022

First Posted

August 29, 2022

Study Start

September 20, 2022

Primary Completion

January 20, 2023

Study Completion

December 20, 2023

Last Updated

September 2, 2022

Record last verified: 2022-07

Locations