SAPHIR2 : Simplification of PHysical Activity Assessment by Rapid Interrogation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
actimeter wearing
Other interventionactimeter wearing during 7 days : recording of physical activity over 7 days using a non-invasive external sensor
physical activities questionnaires
Other interventionIPAQ and SAPHIR questionnaires
Treatment groups
118 Participants
are divided into 1 treatment groupGroup A: SAPHIR2 cohort2 interventions
Trial outcomes
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.
Time frame
7 daysSecondary 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
The first secondary outcome measure is the correlation coefficient between the SAPHIR score and the amount of activity estimated from Activ-PAL® data.
Time frame
7 days2
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
Time frame
inclusion3
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
Time frame
7 days4
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
Time frame
7 daysSponsors and contacts
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Source ClinicalTrials.gov