Validation and Predictive Equation for Sit-to-stand Test... | NCT03670511

Studies
Validation and Predictive Equation for Sit-to-stand Test in Children

NCT03670511

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Completed

Last Update Posted

Sep 17, 2018Actual

Enrollment

397Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

sit-to-stand test
six minute walking test

Countries

Belgium

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

Sep 2018

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

Nov 2016Actual

Primary Completion Date

Nov 2016Actual

Completion Date

Jun 2018Actual

First Submitted Date

Sep 12, 2018

First Submission Date that Met QC Criteria

Sep 12, 2018

First Posted Date

Sep 13, 2018Actual

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

Sep 13, 2018

Last Update Posted Date

Sep 17, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

G.Reychler, Physiotherapist, Cliniques universitaires Saint-Luc- Université Catholique de LouvainPrincipal Investigator

Lead Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de LouvainOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Validation and development of predictive values for the one minute sit-to-stand test in children between 6 and 18 years.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

397Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sit-to-stand	Experimental		Other: sit-to-stand test
six minute walking test	Active Comparator		Other: six minute walking test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sit-to-stand test	Other	to sit and stand from a chair	sit-to-stand

Measure	Description	Time Frame
number of sit-to-stand		1 minute

Measure	Description	Time Frame
pulsed oxygen saturation		1 minute
heart rate		1 minute

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

participation in the national physical education program at school
free of physical activity during one hour preceding the experiments

Exclusion Criteria:

diagnosis of chronic lung, cardiac or neuromuscular disease
BMI higher than 85th percentile for children of the same age and sex
a motor disability based on parents' answer to standardized questions.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques universitaires Saint-Luc		Brussels		1200	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided