NCT04841109

Brief Summary

The aim of this study is to describe the movement of the diaphragm during postural activation of the trunk muscles in comparison with tidal breathing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 22, 2021

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2021

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

28 days

First QC Date

April 8, 2021

Last Update Submit

June 28, 2021

Conditions

Diaphragm Movement

Keywords

diaphragmatic motionm-mode ultrasonographypostural function

Outcome Measures

Primary Outcomes (1)

  • Diaphragm movement

    Distance of the diaphragm from the ultrasound transducer in millimeters during tidal breathing, during holding a load, and during voluntary contraction of the trunk muscles

    6 months

Secondary Outcomes (2)

  • Tidal volume

    6 months

  • Activity of the trunk muscles

    6 months

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy Subjects

You may qualify if:

  • Signed informed consent form
  • Able to comply with the study protocol, in the investigator's judgment
  • Aged 20-40 years, inclusive
  • Healthy as determined by the Investigator based on medical history, physical examination, vital signs and neurological examination
  • Waist-to-height ratio \< 0,59

You may not qualify if:

  • Low back pain (acute or chronic)
  • Previous abdominal or spine surgery
  • Acute or chronic respiratory or musculoskeletal disorder
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks before initiation of the study
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pavel Kolar´s Centre of Physical Medicine

Prague, 158 00, Czechia

Location

Related Publications (1)

  • Sembera M, Busch A, Kobesova A, Hanychova B, Sulc J, Kolar P. The effect of abdominal bracing on respiration during a lifting task: a cross-sectional study. BMC Sports Sci Med Rehabil. 2023 Sep 15;15(1):112. doi: 10.1186/s13102-023-00729-w.

    PMID: 37715283DERIVED

Study Officials

  • Pavel Kolar, Prof, PhD

    Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, Czech Republic

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 12, 2021

Study Start

May 22, 2021

Primary Completion

June 19, 2021

Study Completion

June 19, 2021

Last Updated

June 29, 2021

Record last verified: 2021-06

Locations

CZ(1)