Asymmetric Movement of the Diaphragm | NCT05767411

Studies
Asymmetric Movement of the Diaphragm

NCT05767411

Sponsor

University Hospital, Motol

Status

Completed

Last Update Posted

Jun 22, 2023Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2023Actual

Primary Completion Date

Jun 14, 2023Actual

Completion Date

Jun 21, 2023Actual

First Submitted Date

Mar 2, 2023

First Submission Date that Met QC Criteria

Mar 2, 2023

First Posted Date

Mar 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2023

Last Update Posted Date

Jun 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to investigate the movement of the right hemidiaphragm when lifting a load with the left and right hand.

Detailed Description

Hemidiaphragm movement will be assessed by m-mode ultrasonography in a standing position. The study will include 30-40 healthy adult volunteers. The examination will consist of two tidal inspirations and expirations, two inspirations and expirations during lifting the kettlebell with the left hand and two inspirations and expirations during lifting the kettlebell with the right hand. The weight of the kettlebell will correspond to about 10% of the participant's body weight.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemidiaphragm movement	Distance of the diaphragm from the ultrasound transducer in millimeters during tidal breathing, and when lifting a load with the left and right hand.	7 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent form
Able to comply with the study protocol, in the investigator's judgment
Aged 18-40 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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Healthy Subjects

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pavel Kolar, Prof, PhD	Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, Czech Republic	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pavel Kolar´s Centre of Physical Medicine		Prague		158 00	Czechia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided