HealthyNCT03670511
Validation and Predictive Equation for Sit-to-stand Test in Children
A study testing sit-to-stand test and six minute walking test in people with Healthy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Validation and development of predictive values for the one minute sit-to-stand test in children between 6 and 18 years. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- sit-to-stand test and six minute walking test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 397 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- participation in the national physical education program at school
- free of physical activity during one hour preceding the experiments
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Validation and development of predictive values for the one minute sit-to-stand test in children between 6 and 18 years.
- Conditions
- Healthy
- Being tested
- sit-to-stand test, six minute walking test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sit-to-stand testOther
to sit and stand from a chair
six minute walking testOther
to walk for six minutes
| Study group | Role | What they receive |
|---|---|---|
| sit-to-stand | Experimental | Not described Receives: Other: sit-to-stand test |
| six minute walking test | Active comparator | Not described Receives: Other: six minute walking test |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of sit-to-stand
Measured: 1 minute
Secondary outcomes (2)
pulsed oxygen saturation
Measured: 1 minute
heart rate
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study startNov 2016
- Primary completionNov 2016
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670511
- Sponsor's protocol ID
- STSTvalid
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2018
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Predictive Equation for Sit-to-stand Test in Children
- ClinicalTrials.gov ID
- NCT03670511
- Acronym / sponsor ID
- STSTvalid
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Validation and development of predictive values for the one minute sit-to-stand test in children between 6 and 18 years.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sit-to-stand | Experimental | Other: sit-to-stand test |
| six minute walking test | Active comparator | Other: six minute walking test |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- participation in the national physical education program at school
- free of physical activity during one hour preceding the experiments
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sit-to-stand testto sit and stand from a chair | Other | sit-to-stand |
| six minute walking testto walk for six minutes | Other | six minute walking test |
Primary outcome
number of sit-to-stand
Time frame: 1 minute
2 secondary outcomes
pulsed oxygen saturation
Time frame: 1 minute
heart rate
Time frame: 1 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sit-to-stand test and six minute walking test in people with Healthy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of sit-to-stand (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.