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NCT Number: NCT07147608

SAPHIR2 : Simplification of PHysical Activity Assessment by Rapid Interrogation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

actimeter wearing

Other

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

physical activities questionnaires

Other

IPAQ and SAPHIR questionnaires

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    The first secondary outcome measure is the correlation coefficient between the SAPHIR score and the amount of activity estimated from Activ-PAL® data.

  2. correlation between the initial SAPHIR score and the IPAQ score (baseline)

    Time frame: inclusion

    The second secondary outcome measure is the correlation coefficient between the initial SAPHIR score and the initial IPAQ score

  3. correlation between the final SAPHIR score and the final IPAQ score

    Time frame: 7 days

    The third secondary outcome measure is the correlation coefficient between the final SAPHIR score and the final IPAQ score

  4. 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

    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

  5. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Anthéa LOIEZ

CONTACT

[email protected]

02 41 35 36 37 ext. +33

Simon LECOQ, MD

CONTACT

[email protected]

02 41 35 36 37 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

Simplification of PHysical Activity Assessment by Rapid Interrogation - Phase 2

Acronym: SAPHIR2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 29, 2025
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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