Sedentary BehaviorSAPHIRNCT04548141
Quick Questionnaire to Evaluate Physical Activity
A study testing Questionnaire in people with Sedentary Behavior, run by University Hospital, Angers at 1 site in France.
Trial summary
The purpose of this study is to test and validate a new questionnaire (SAPHIR) in order to get an evaluation of patients physical activity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2020to 21 Sep 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- French Native language
- Covered by the French social care system
- Be referred for a consultation to the Sports Medicine Service of Angers Hospital or to the CRSS of Angers
Who cannot join
- Person opposed to participating in the research
- Person unable to understand the objectives of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simplification de l'évaluation de l'Activité PHysique Par Interrogatoire Rapide
The purpose of this study is to test and validate a new questionnaire (SAPHIR) in order to get an evaluation of patients physical activity.
Read the detailed description
Two questionnaires the SAPHIR and the "International Physical Activity Questionnaire" (IPAQ) are submitted (self completion) to patients referred for consultation.
Retrival of physical activity data on podometer if available
- Conditions
- Sedentary Behavior
- Being tested
- Questionnaire
- Keywords
- Physical activity, Questionnaire
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Scoring of the IPAQ is performed according to references. Scoring of the SAPHIR has been submitted for copyright protection (involves a series of 23 additions)
| Study group | Role | What they receive |
|---|---|---|
| Active adults | Experimental | Adults coming for a visit for sports activity participation and submitted the SAPHIR questionnaire Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of questionnaires with errors after self completion
Estimation of the percentage of errors with 90% confidence interval Comparison of the two percentages
Measured: 1 day
Secondary outcomes (3)
Facility of the filling of the questionnaires
Ease of use évaluation for the patient using Likert scale (from "Totally agree" to "not agree at all" in 5 grades)
Measured: 1 day
Correlation of the SAPHIR questionnaire to the IPAQ questionnaire
Correlation coefficient with the IPAQ questionnaire
Measured: 1 day
Correlation of the SAPHIR questionnaire to the number of weekly steps for patients who have a pedometer available
The correlation coefficient with the number of steps will be studied
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start26 Nov 2020
- Primary completion21 Sep 2021
- Study completion21 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Self completion of questionnaire in the waiting room
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Principal investigator, DENISE JOLIVOT, University Hospital, Angers
- Investigators
- Pierre ABRAHAM, Principal investigator, University and Hospital in Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548141
- Sponsor's protocol ID
- SAPHIR
- Acronym
- SAPHIR
- Status last verified
- Jun 2022
- First submitted
- 8 Sep 2020
- Last updated
- 24 Jun 2022
- 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 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplification de l'évaluation de l'Activité PHysique Par Interrogatoire Rapide
- ClinicalTrials.gov ID
- NCT04548141
- Acronym / sponsor ID
- SAPHIR / SAPHIR
- Conditions
- Sedentary Behavior
- Keywords
- Physical activity, Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 21 Sep 2021 (actual)
- First posted
- 14 Sep 2020 (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.
The purpose of this study is to test and validate a new questionnaire (SAPHIR) in order to get an evaluation of patients physical activity.
Detailed description
Two questionnaires the SAPHIR and the "International Physical Activity Questionnaire" (IPAQ) are submitted (self completion) to patients referred for consultation.
Retrival of physical activity data on podometer if available
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Self completion of questionnaire in the waiting room
| Arm | Type | Receives |
|---|---|---|
| Active adults | Experimental | Other: QuestionnaireAdults coming for a visit for sports activity participation and submitted the SAPHIR questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- French Native language
- Covered by the French social care system
- Be referred for a consultation to the Sports Medicine Service of Angers Hospital or to the CRSS of Angers
Key exclusion criteria (2 listed)
- Person opposed to participating in the research
- Person unable to understand the objectives of the study
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 |
|---|---|---|
| QuestionnaireScoring of the IPAQ is performed according to references. Scoring of the SAPHIR has been submitted for copyright protection (involves a series of 23 additions) | Other | Active adults |
Primary outcome
Proportion of questionnaires with errors after self completion
Time frame: 1 day
Estimation of the percentage of errors with 90% confidence interval Comparison of the two percentages
3 secondary outcomes
Facility of the filling of the questionnaires
Time frame: 1 day
Correlation of the SAPHIR questionnaire to the IPAQ questionnaire
Time frame: 1 day
Correlation of the SAPHIR questionnaire to the number of weekly steps for patients who have a pedometer available
Time frame: 1 day
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 24 Jun 2022.
- 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.
Pierre ABRAHAM principal investigator
University and Hospital in Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Sedentary Behavior, run by University Hospital, Angers at 1 site in France.
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 3 inclusion and 2 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 24 Jun 2022. 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 France. 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?
Proportion of questionnaires with errors after self completion (time frame: 1 day). 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 24 Jun 2022.