actimeter wearing
Otheractimeter wearing during 7 days : recording of physical activity over 7 days using a non-invasive external sensor
NCT Number: NCT07147608
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
CHU d'Angers, Angers, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non-inclusion criteria:
Exclusion criteria
-Patients with Activ-PAL recordings of less than 3 days
actimeter wearing during 7 days : recording of physical activity over 7 days using a non-invasive external sensor
IPAQ and SAPHIR questionnaires
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.
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.
Time frame: inclusion
The second secondary outcome measure is the correlation coefficient between the initial SAPHIR score and the initial 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
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
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
Contact information is provided by the study sponsor or research team.
University Hospital, Angers
Other Gov
Simplification of PHysical Activity Assessment by Rapid Interrogation - Phase 2
Acronym: SAPHIR2
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.
Published trials that share one or more normalized conditions with this study.
NCT07212400
Disease, General Population (no Specific Condition or Disease)
Jouy-en-Josas, France
View Trial DetailsNCT05562128
Disease, General Population (no Specific Condition or Disease)
Berlin, State of Berlin, Germany
View Trial DetailsNCT07492056
Disease, General Population (no Specific Condition or Disease)
View Trial DetailsNCT07473466
Disease, General Population (no Specific Condition or Disease)
Paris, France
View Trial Details