- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03670511
Validation and Predictive Equation for Sit-to-stand Test in Children
September 13, 2018 updated by: G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Validation and development of predictive values for the one minute sit-to-stand test in children between 6 and 18 years.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
397
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brussels, Belgium, 1200
- Cliniques Universitaires Saint-Luc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: sit-to-stand
|
to sit and stand from a chair
|
|
Active Comparator: six minute walking test
|
to walk for six minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
number of sit-to-stand
Time Frame: 1 minute
|
1 minute
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
heart rate
Time Frame: 1 minute
|
1 minute
|
|
pulsed oxygen saturation
Time Frame: 1 minute
|
1 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2016
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
September 12, 2018
First Submitted That Met QC Criteria
September 12, 2018
First Posted (Actual)
September 13, 2018
Study Record Updates
Last Update Posted (Actual)
September 17, 2018
Last Update Submitted That Met QC Criteria
September 13, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- STSTvalid
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.