NCT07147608

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Dec 2025

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Dec 2025Jun 2027

First Submitted

Initial submission to the registry

August 21, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

December 19, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

1.4 years

First QC Date

August 21, 2025

Last Update Submit

December 19, 2025

Conditions

Keywords

exercisesedentary behaviorsports medicine

Outcome Measures

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

    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.

    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

    7 days

  • correlation between the initial SAPHIR score and the IPAQ score (baseline)

    inclusion

  • correlation between the final SAPHIR score and the final IPAQ score

    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

    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

    7 days

Study Arms (1)

SAPHIR2 cohort

Initial physical activity questionnaire, wearing the actimeter for 7 days, final physical activity questionnaire

Other: actimeter wearingOther: physical activities questionnaires

Interventions

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

SAPHIR2 cohort

IPAQ and SAPHIR questionnaires

SAPHIR2 cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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)

You may qualify if:

  • 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
  • Patients unable to understand the objectives or instructions of the study

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU d'Angers

Angers, 49933, France

RECRUITING

CH de Cholet

Cholet, 49325, France

NOT YET RECRUITING

CH du Mans

Le Mans, 72037, France

NOT YET RECRUITING

Related Publications (7)

  • 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.

  • Kwak 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.

  • Joseph 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.

  • Curry 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.

  • Wu 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.

  • Tudor-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.

  • Tudor-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.

MeSH Terms

Conditions

DiseaseMotor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Simon LECOQ, MD

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2025

First Posted

August 29, 2025

Study Start

December 19, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations