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SAPHIR2 : Simplification of PHysical Activity Assessment by Rapid Interrogation

Simplification of PHysical Activity Assessment by Rapid Interrogation - Phase 2

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07147608
Acronym
SAPHIR2
Enrollment
118
Registered
2025-08-29
Start date
2025-12-19
Completion date
2027-06-01
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Population (no Specific Condition or Disease)

Keywords

exercise, sedentary behavior, sports medicine

Brief 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. 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.

Interventions

OTHERactimeter wearing

actimeter wearing during 7 days : recording of physical activity over 7 days using a non-invasive external sensor

OTHERphysical activities questionnaires

IPAQ and SAPHIR questionnaires

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

-Patients with Activ-PAL recordings of less than 3 days

Design outcomes

Primary

MeasureTime frameDescription
correlation between SAPHIR score completed at inclusion and the level of physical activity estimated from measurement data collected using the Activ-PAL® activity monitor7 daysA 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.

Secondary

MeasureTime frameDescription
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 data7 daysThe first secondary outcome measure is the correlation coefficient between the SAPHIR score and the amount of activity estimated from Activ-PAL® data.
correlation between the initial SAPHIR score and the IPAQ score (baseline)inclusionThe second secondary outcome measure is the correlation coefficient between the initial SAPHIR score and the initial IPAQ score
correlation between the final SAPHIR score and the final IPAQ score7 daysThe third secondary outcome measure is the correlation coefficient between the final SAPHIR score and the final IPAQ score
correlation between the initial IPAQ score (at the beginning of the week) and the amount of physical activity calculated using Activ-PAL® data i7 daysThe 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
correlation between the final IPAQ score (at the end of the recording week) and the amount of physical activity calculated using Activ-PAL® data7 daysThe 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

Countries

France

Contacts

CONTACTSimon LECOQ, MD
Simon.Lecoq@chu-angers.fr02 41 35 36 37
CONTACTAnthéa LOIEZ
DRCI-Promotion-Interne@chu-angers.fr02 41 35 36 37
PRINCIPAL_INVESTIGATORSimon LECOQ, MD

University Hospital, Angers

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026