NCT03670511

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
397

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable healthy

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

Study Start

First participant enrolled

November 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
Last Updated

September 17, 2018

Status Verified

September 1, 2018

Enrollment Period

Same day

First QC Date

September 12, 2018

Last Update Submit

September 13, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • number of sit-to-stand

    1 minute

Secondary Outcomes (2)

  • pulsed oxygen saturation

    1 minute

  • heart rate

    1 minute

Study Arms (2)

sit-to-stand

EXPERIMENTAL
Other: sit-to-stand test

six minute walking test

ACTIVE COMPARATOR
Other: six minute walking test

Interventions

sit-to-stand testOTHER

to sit and stand from a chair

sit-to-stand
six minute walking testOTHER

to walk for six minutes

six minute walking test

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 13, 2018

Study Start

November 1, 2016

Primary Completion

November 1, 2016

Study Completion

June 1, 2018

Last Updated

September 17, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)