General Population (no Specific Condition or Disease)SAPHIR2NCT07147608
SAPHIR2 : Simplification of PHysical Activity Assessment by Rapid Interrogation
An observational study of General Population (no Specific Condition or Disease), run by University Hospital, Angers at 3 sites in France.
Trial summary
A multicentric, non-interventional study using a clinical questionnaire (SAPHIR) and activity monitor (Activ-PAL) to estimate the level of physical activity in the general population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Population (no Specific Condition or Disease)
- What is being tested?
- actimeter wearing and physical activities questionnaires
- How many people
- 118 participants
- Where
- 3 sitesFrance
- Study dates
- 19 Dec 2025to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients referred for consultation in the department of sports medicine (generally active patients, although patients may also be sedentary and/or inactive) or in the department of vascular medicine (patients with lower limb peripheral artery disease, mostly inactive)
Who may be able to join
- Patients referred for a consultation at one of the participating centers
- Patients over 18 years old with no upper age limit
- Non-inclusion criteria:
- Patients with a contra-indication to walking
- Professional athletes or patients participating in endurance sports competitions
- Patients refusing to participate in the study
- Patients unable to understand the objectives or instructions of the study
Who cannot join
- -Patients with Activ-PAL recordings of less than 3 days
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CHU d'Angers
Angers, 49933
Simon LECOQ, MD, 0241353637 ext. +33, simon.lecoq@chu-angers.fr
- Not yet recruiting
CH de Cholet
Cholet, 49325
Jean-Eudes TRIHAN, MD, 02 41 49 64 30 ext. +33, jean-eudes.trihan@ch-cholet.fr
- Not yet recruiting
CH du Mans
Le Mans, 72037
Muriel MECHENIN, MD, 02 43 43 43 43 ext. +33, mmechenin@ch-lemans.fr
About this study
Official title: Simplification of PHysical Activity Assessment by Rapid Interrogation - Phase 2
A multicentric, non-interventional study using a clinical questionnaire (SAPHIR) and activity monitor (Activ-PAL) to estimate the level of physical activity in the general population.
This study compares the level of physical activity reported by the SAPHIR questionnaire with the activity recorded by the activity monitor during the same period, in order to determine if the SAPHIR score is able to represent the measured physical activity, in a simple and easily calculable manner.
Read more
Hypothesis:
The aim of this work is to propose a new questionnaire that is simple to complete by the patient,quick to analyse and directly calculable by the doctor and adapted to the general population, whether during the initial evaluation or the follow-up.
Indeed, these scores are rarely used outside the context of the prescription of physical activity in specialized centers. Moreover, a tool suited to the constraints of community medicine seems necessary, given the growth of the prescription of physical activity in primary care.
The idea behind this new questionnaire is to obtain a score ranging from 0 to 100 that can be calculated through simple mental arithmetic, which is not the case for most existing questionnaires, in particular the IPAQ.
Read the detailed description
Promotion of physical activity has been an important public health issue in France for around ten years, as demonstrated by numerous reports and public health plans 'qui ont vu le jour" with this aim. (Plan national nutrition santé PNNS 2011-2015 ; Plan obésité PO 2010-2013 ; Plan cancer 2014-2019). In order to continue promoting physical activity (PA), it is necessary to have a well-adapted, simple and rapid tool is that allows precise evaluation and monitoring within the general population.
Currently, the French National Authority for Health (la Haute Autorité de Santé), through its guide for the promotion, consultation and medical prescription of physical and sports activity for health in adults, updated in July 2022, proposes an estimate of the "usual level of PA (…) using the two-question Marshall questionnaire (30 seconds)" or alternatively, "it can be calculated more precisely with the Global Physical Activity Questionnaire (GPAQ), a 16-question self-administered questionnaire that patients can complete online at www.mangerbouger.fr."
The GPAQ is one of the most widely used questionnaires. While its strength lies in its precision, it is long to complete and score. Therefore, despite being validated by many studies, it is not practical for routine use. In practice, the "Ricci and Gagnon" questionnaire is used for the follow-up of patients, using tracking logs. (Sport santé sur ordonnance. Contexte et exemples de mise en oeuvre. Octobre 2017. ONAPS) . This categorizes individuals as inactive, active or very active, and has never been scientifically validated in a study, to the best of our knowledge.
Finally, the International Physical Activity Questionnaire (IPAQ) is a test validated both in long and short forms. It allows a precise calculation of the amount of physical activity expressed in MET (metabolic equivalent)/min/week but does not provide information on its distribution throughout the week. Like the GPAQ, with 27 different questions it is also lengthy to complete, making it impractical for routine use. The short version tends to underestimate physical activity levels, and the final score cannot be easily calculated in real time. Nevertheless, this version will be used as a reference.
The aim of this work is to propose a new questionnaire that is simple for patients to complete, quick to analyse, can be calculated directly by the doctor, and is adapted to the general population, whether for an initial assessment or a follow-up.
Moreover, the prescription of physical activity is usually carried out over short, renewable periods, whereas long-term changes are necessary to achieve significant improvements in morbidity and mortality.
The developed questionnaire ultimately aims to be useful for monitoring the evolution of physical activity.
- Being tested
- actimeter wearing, physical activities questionnaires
- Keywords
- exercise, sedentary behavior, sports medicine
- Medical subject headings
- Disease, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
actimeter wearingOther
actimeter wearing during 7 days : recording of physical activity over 7 days using a non-invasive external sensor
physical activities questionnairesOther
IPAQ and SAPHIR questionnaires
| Study group | Role | What they receive |
|---|---|---|
| SAPHIR2 cohort | Initial physical activity questionnaire, wearing the actimeter for 7 days, final physical activity questionnaire Receives: Other: actimeter wearing; Other: physical activities questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between SAPHIR score completed at inclusion and the level of physical activity estimated from measurement data collected using the Activ-PAL® activity monitor
A score is based on the time spent at each intensity level of physical activity, using the correlation between cadence and METs extrapolated from the literature (Tudor-Locke et al, 2020). The primary outcome measure is the correlation coefficient between the amount of physical activity estimated by the SAPHIR score and that estimated from the Activ-PAL data.
Measured: 7 days
Secondary outcomes (5)
correlation between the final SAPHIR score (completed at the end of the measurement week) and the amount of physical activity calculated from the Activ-PAL® activity monitor data
The first secondary outcome measure is the correlation coefficient between the SAPHIR score and the amount of activity estimated from Activ-PAL® data.
Measured: 7 days
correlation between the initial SAPHIR score and the IPAQ score (baseline)
The second secondary outcome measure is the correlation coefficient between the initial SAPHIR score and the initial IPAQ score
Measured: inclusion
correlation between the final SAPHIR score and the final IPAQ score
The third secondary outcome measure is the correlation coefficient between the final SAPHIR score and the final IPAQ score
Measured: 7 days
correlation between the initial IPAQ score (at the beginning of the week) and the amount of physical activity calculated using Activ-PAL® data i
The fourth secondary outcome measure is the correlation coefficient between the initial IPAQ score and the amount of physical activity estimated from Activ-PAL® data, using the method described for the primary outcome
Measured: 7 days
correlation between the final IPAQ score (at the end of the recording week) and the amount of physical activity calculated using Activ-PAL® data
The fifth secondary outcome measure is the correlation coefficient between the final IPAQ score and the amount of activity measured from Activ-PAL® data, following the method described for the primary outcome
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start19 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for General Population (no Specific Condition or Disease)Studies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Simon LECOQ, MD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147608
- Sponsor's protocol ID
- 49RC25_0220
- Acronym
- SAPHIR2
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Publications
Hillsdon M, Foster C, Thorogood M. Interventions for promoting physical activity. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD003180. doi: 10.1002/14651858.CD003180.pub2.
PubMed 15674903Kwak L, Hagstromer M, Sjostrom M. Can the IPAQ-long be used to assess occupational physical activity? J Phys Act Health. 2012 Nov;9(8):1130-7. doi: 10.1123/jpah.9.8.1130. Epub 2011 Dec 27.
PubMed 22207150Joseph KL, Dagfinrud H, Christie A, Hagen KB, Tveter AT. Criterion validity of The International Physical Activity Questionnaire-Short Form (IPAQ-SF) for use in clinical practice in patients with osteoarthritis. BMC Musculoskelet Disord. 2021 Feb 27;22(1):232. doi: 10.1186/s12891-021-04069-z.
PubMed 33639913Curry WB, Thompson JL. Comparability of accelerometer- and IPAQ-derived physical activity and sedentary time in South Asian women: A cross-sectional study. Eur J Sport Sci. 2015;15(7):655-62. doi: 10.1080/17461391.2014.957728. Epub 2014 Sep 24.
PubMed 25252088Wu Y, Johns JA, Poitras J, Kimmerly DS, O'Brien MW. Improving the criterion validity of the activPAL in determining physical activity intensity during laboratory and free-living conditions. J Sports Sci. 2021 Apr;39(7):826-834. doi: 10.1080/02640414.2020.1847503. Epub 2020 Nov 18.
PubMed 33203323Tudor-Locke C, Aguiar EJ, Han H, Ducharme SW, Schuna JM Jr, Barreira TV, Moore CC, Busa MA, Lim J, Sirard JR, Chipkin SR, Staudenmayer J. Walking cadence (steps/min) and intensity in 21-40 year olds: CADENCE-adults. Int J Behav Nutr Phys Act. 2019 Jan 17;16(1):8. doi: 10.1186/s12966-019-0769-6.
PubMed 30654810Tudor-Locke C, Ducharme SW, Aguiar EJ, Schuna JM Jr, Barreira TV, Moore CC, Chase CJ, Gould ZR, Amalbert-Birriel MA, Mora-Gonzalez J, Chipkin SR, Staudenmayer J. Walking cadence (steps/min) and intensity in 41 to 60-year-old adults: the CADENCE-adults study. Int J Behav Nutr Phys Act. 2020 Nov 10;17(1):137. doi: 10.1186/s12966-020-01045-z.
PubMed 33168018
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplification of PHysical Activity Assessment by Rapid Interrogation - Phase 2
- ClinicalTrials.gov ID
- NCT07147608
- Acronym / sponsor ID
- SAPHIR2 / 49RC25_0220
- Keywords
- exercise, sedentary behavior, sports medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Aug 2025 (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.
A multicentric, non-interventional study using a clinical questionnaire (SAPHIR) and activity monitor (Activ-PAL) to estimate the level of physical activity in the general population.
This study compares the level of physical activity reported by the SAPHIR questionnaire with the activity recorded by the activity monitor during the same period, in order to determine if the SAPHIR score is able to represent the measured physical activity, in a simple and easily calculable manner.
Hypothesis:
The aim of this work is to propose a new questionnaire that is simple to complete by the patient,quick to analyse and directly calculable by the doctor and adapted to the general population, whether during the initial evaluation or the follow-up.
Indeed, these scores are rarely used outside the context of the prescription of physical activity in specialized centers. Moreover, a tool suited to the constraints of community medicine seems necessary, given the growth of the prescription of physical activity in primary care.
The idea behind this new questionnaire is to obtain a score ranging from 0 to 100 that can be calculated through simple mental arithmetic, which is not the case for most existing questionnaires, in particular the IPAQ.
Detailed description
Promotion of physical activity has been an important public health issue in France for around ten years, as demonstrated by numerous reports and public health plans 'qui ont vu le jour" with this aim. (Plan national nutrition santé PNNS 2011-2015 ; Plan obésité PO 2010-2013 ; Plan cancer 2014-2019). In order to continue promoting physical activity (PA), it is necessary to have a well-adapted, simple and rapid tool is that allows precise evaluation and monitoring within the general population.
Currently, the French National Authority for Health (la Haute Autorité de Santé), through its guide for the promotion, consultation and medical prescription of physical and sports activity for health in adults, updated in July 2022, proposes an estimate of the "usual level of PA (…) using the two-question Marshall questionnaire (30 seconds)" or alternatively, "it can be calculated more precisely with the Global Physical Activity Questionnaire (GPAQ), a 16-question self-administered questionnaire that patients can complete online at www.mangerbouger.fr."
The GPAQ is one of the most widely used questionnaires. While its strength lies in its precision, it is long to complete and score. Therefore, despite being validated by many studies, it is not practical for routine use. In practice, the "Ricci and Gagnon" questionnaire is used for the follow-up of patients, using tracking logs. (Sport santé sur ordonnance. Contexte et exemples de mise en oeuvre. Octobre 2017. ONAPS) . This categorizes individuals as inactive, active or very active, and has never been scientifically validated in a study, to the best of our knowledge.
Finally, the International Physical Activity Questionnaire (IPAQ) is a test validated both in long and short forms. It allows a precise calculation of the amount of physical activity expressed in MET (metabolic equivalent)/min/week but does not provide information on its distribution throughout the week. Like the GPAQ, with 27 different questions it is also lengthy to complete, making it impractical for routine use. The short version tends to underestimate physical activity levels, and the final score cannot be easily calculated in real time. Nevertheless, this version will be used as a reference.
The aim of this work is to propose a new questionnaire that is simple for patients to complete, quick to analyse, can be calculated directly by the doctor, and is adapted to the general population, whether for an initial assessment or a follow-up.
Moreover, the prescription of physical activity is usually carried out over short, renewable periods, whereas long-term changes are necessary to achieve significant improvements in morbidity and mortality.
The developed questionnaire ultimately aims to be useful for monitoring the evolution of physical activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAPHIR2 cohort | – | Other: actimeter wearing, Other: physical activities questionnairesInitial physical activity questionnaire, wearing the actimeter for 7 days, final physical activity questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients referred for consultation in the department of sports medicine (generally active patients, although patients may also be sedentary and/or inactive) or in the department of vascular medicine (patients with lower limb peripheral artery disease, mostly inactive)
Key inclusion criteria (7 listed)
- Patients referred for a consultation at one of the participating centers
- Patients over 18 years old with no upper age limit
- Patients with a contra-indication to walking
- Professional athletes or patients participating in endurance sports competitions
- Patients refusing to participate in the study
Key exclusion criteria (1 listed)
- -Patients with Activ-PAL recordings of less than 3 days
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 |
|---|---|---|
| actimeter wearingactimeter wearing during 7 days : recording of physical activity over 7 days using a non-invasive external sensor | Other | SAPHIR2 cohort |
| physical activities questionnairesIPAQ and SAPHIR questionnaires | Other | SAPHIR2 cohort |
Primary outcome
correlation between SAPHIR score completed at inclusion and the level of physical activity estimated from measurement data collected using the Activ-PAL® activity monitor
Time frame: 7 days
A score is based on the time spent at each intensity level of physical activity, using the correlation between cadence and METs extrapolated from the literature (Tudor-Locke et al, 2020). The primary outcome measure is the correlation coefficient between the amount of physical activity estimated by the SAPHIR score and that estimated from the Activ-PAL data.
5 secondary outcomes
correlation between the final SAPHIR score (completed at the end of the measurement week) and the amount of physical activity calculated from the Activ-PAL® activity monitor data
Time frame: 7 days
correlation between the initial SAPHIR score and the IPAQ score (baseline)
Time frame: inclusion
correlation between the final SAPHIR score and the final IPAQ score
Time frame: 7 days
correlation between the initial IPAQ score (at the beginning of the week) and the amount of physical activity calculated using Activ-PAL® data i
Time frame: 7 days
correlation between the final IPAQ score (at the end of the recording week) and the amount of physical activity calculated using Activ-PAL® data
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Results publication: PubMed 15674903Hillsdon M, Foster C, Thorogood M. Interventions for promoting physical activity. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD003180. doi: 10.1002/14651858.CD003180.pub2.
- Results publication: PubMed 22207150Kwak L, Hagstromer M, Sjostrom M. Can the IPAQ-long be used to assess occupational physical activity? J Phys Act Health. 2012 Nov;9(8):1130-7. doi: 10.1123/jpah.9.8.1130. Epub 2011 Dec 27.
- Results publication: PubMed 33639913Joseph KL, Dagfinrud H, Christie A, Hagen KB, Tveter AT. Criterion validity of The International Physical Activity Questionnaire-Short Form (IPAQ-SF) for use in clinical practice in patients with osteoarthritis. BMC Musculoskelet Disord. 2021 Feb 27;22(1):232. doi: 10.1186/s12891-021-04069-z.
- Results publication: PubMed 25252088Curry WB, Thompson JL. Comparability of accelerometer- and IPAQ-derived physical activity and sedentary time in South Asian women: A cross-sectional study. Eur J Sport Sci. 2015;15(7):655-62. doi: 10.1080/17461391.2014.957728. Epub 2014 Sep 24.
- Results publication: PubMed 33203323Wu Y, Johns JA, Poitras J, Kimmerly DS, O'Brien MW. Improving the criterion validity of the activPAL in determining physical activity intensity during laboratory and free-living conditions. J Sports Sci. 2021 Apr;39(7):826-834. doi: 10.1080/02640414.2020.1847503. Epub 2020 Nov 18.
- Results publication: PubMed 30654810Tudor-Locke C, Aguiar EJ, Han H, Ducharme SW, Schuna JM Jr, Barreira TV, Moore CC, Busa MA, Lim J, Sirard JR, Chipkin SR, Staudenmayer J. Walking cadence (steps/min) and intensity in 21-40 year olds: CADENCE-adults. Int J Behav Nutr Phys Act. 2019 Jan 17;16(1):8. doi: 10.1186/s12966-019-0769-6.
- Results publication: PubMed 33168018Tudor-Locke C, Ducharme SW, Aguiar EJ, Schuna JM Jr, Barreira TV, Moore CC, Chase CJ, Gould ZR, Amalbert-Birriel MA, Mora-Gonzalez J, Chipkin SR, Staudenmayer J. Walking cadence (steps/min) and intensity in 41 to 60-year-old adults: the CADENCE-adults study. Int J Behav Nutr Phys Act. 2020 Nov 10;17(1):137. doi: 10.1186/s12966-020-01045-z.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
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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.
Simon LECOQ, MD principal investigator
University Hospital, Angers
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Population (no Specific Condition or Disease), run by University Hospital, Angers at 3 sites 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 7 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon LECOQ, MD (02 41 35 36 37 ext. +33, Simon.Lecoq@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between SAPHIR score completed at inclusion and the level of physical activity estimated from measurement data collected using the Activ-PAL® activity monitor (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07147608, which also lists 7 linked publications.
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 15 Jun 2026.