- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07582406
Codesign, Physical Activity, and Seniors (CAPS)
7 mai 2026 mis à jour par: Centre Hospitalier Universitaire de Nice
Codesign, Physical Activity and Seniors
The benefits of physical activity are well-established.
However, adherence to and sustained participation remain limited.
These difficulties are partly explained by a lack of consideration for individual differences and the psychosocial factors influencing motivation and participation.
Models from the psychology of motivation, such as the transtheoretical model of change, emphasize the importance of support tailored to each individual's level of commitment and personal needs.
From this perspective, social design, based on co-creation and the active participation of users, could be a promising approach for individualizing interventions with defined, sustainable, and replicable methodologies.
By involving seniors in the design and adjustment of programs, this approach promotes autonomy, a sense of competence, and long-term continuity of practice.
Thus, the objective of this study is to determine the effects of co-created physical activity programs with participants on program adherence and long-term physical activity adoption.
The hypothesis is that co-created physical activity would lead to better adherence and long-term commitment.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Olivier GUERIN, Pr
- Numéro de téléphone: +33 492034194
- E-mail: guerin.o@chu-nice.fr
Lieux d'étude
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Nice, France
- Chu De Nice
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Contact:
- Virginie PIOVANO
- Numéro de téléphone: +33 492034194
- E-mail: piovano.v@chu-nice.fr
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Be 60 years of age or older
- Be characterized by stage 1, 2, or 3 according to the Transtheoretical Model of Behavior Change (Prochaska and DiClemente, 1992).
- Be registered with social security
- Sign the informed consent form
Exclusion Criteria:
- Presence of a physical or cognitive condition preventing completion of the adapted physical activity protocol over 3 months.
- Being characterized by stage 4 or 5 according to the Transtheoretical Model of Behavior Change (Prochaska and DiClemente, 1992).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Co-designed tailored physical activity program
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The 'Co-designed tailored physical activity program' group follows a co-created adapted physical activity program, consisting of two sessions per week for 12 weeks, including adapted physical and sporting activities (APSA) chosen by the participants themselves (3 out of 5 offered).
Within the experimental group, participants are grouped according to their level of physical ability.
In addition, a group discussion with the Adapted Physical Activity Instructor is scheduled every four weeks.
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Comparateur actif: Classical tailored physical activity program
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The 'Classical tailored physical activity program'(control) group follows a classic adapted physical activity program not co-created, of the same duration of 12 weeks with 2 sessions per week.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Maintenance of physical activity
Délai: 6 months and 1 year after the end of the intervention (T2, T3)
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Maintenance of physical activity corresponds to the physical activity levels at 6 months and 1 year post-program.
It will be measured by the Dijon questionnaire which is a self-administered questionnaire, comprising 9 items assessing the frequency, duration and intensity of physical activities carried out in daily life and leisure.
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6 months and 1 year after the end of the intervention (T2, T3)
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Adherence of physical activity program
Délai: Through intervention completion, for 12 weeks.
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Adherence corresponds to attendance rates at physical activity sessions during the program.
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Through intervention completion, for 12 weeks.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Stages of behavior change according to the transtheoretical model of behavior change
Délai: Before the intervention (T0), at the end of the intervention (T1), 6 month after the end of the intervention (T2) and 1 year after the end of the intervention (T3)
|
Stages of behavior change corresponds to the stage a person is at in a behavioral change process.
It is measured via questionnaire which give the stages of behavior of the person (Stage 1, 2, 3 or 4)
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Before the intervention (T0), at the end of the intervention (T1), 6 month after the end of the intervention (T2) and 1 year after the end of the intervention (T3)
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Change process according to the transtheoretical model of behavior change
Délai: Before the intervention (T0), at the end of the intervention (T1), 6 month after the end of the intervention (T2) and 1 year after the end of the intervention (T3)
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Change process corresponds to the mechanisms (strategies) that allow a person to move from one stage to another.
It is the "levers" of change.
It is measured via questionnaire.
Each process is evaluated via several items.
A score is obtained for each process.
The higher the score, the more the person uses that process.
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Before the intervention (T0), at the end of the intervention (T1), 6 month after the end of the intervention (T2) and 1 year after the end of the intervention (T3)
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Decisionnal balance according to the transtheoretical model of behavior change
Délai: Before the intervention (T0), at the end of the intervention (T1), 6 month after the end of the intervention (T2) and 1 year after the end of the intervention (T3)
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The decisional balance refers to how a person weighs the advantages and disadvantages of a change in behavior.
It is measured via questionnaire which provides a score for the advantages and one for the disadvantages.
The overall score represents the ratio between the two, indicating whether the person perceives more advantages or disadvantages in engaging in a behavior.
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Before the intervention (T0), at the end of the intervention (T1), 6 month after the end of the intervention (T2) and 1 year after the end of the intervention (T3)
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Self-efficacy according to the transtheoretical model of behavior change
Délai: Before the intervention (T0), at the end of the intervention (T1), 6 month after the end of the intervention (T2) and 1 year after the end of the intervention (T3)
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Self-efficacy corresponds to a person's confidence in their ability to successfully change their behavior.
It is measured via questionnaire.
The higher the score the more capable the person feels of succeeding.
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Before the intervention (T0), at the end of the intervention (T1), 6 month after the end of the intervention (T2) and 1 year after the end of the intervention (T3)
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Body composition
Délai: Before the intervention (T0) and at the end of the intervention (T1)
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Composition in lean mass and fat mass.
It will assessed by dual-energy X-ray absorptiometry (DXA).
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Before the intervention (T0) and at the end of the intervention (T1)
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Walking capacities (physical capacities)
Délai: Before the intervention (T0) and at the end of the intervention (T1)
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Walking speed (meter/sec)
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Before the intervention (T0) and at the end of the intervention (T1)
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Balance (physical capacities)
Délai: Before the intervention (T0) and at the end of the intervention (T1)
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Postural balance, assessed using a K-Invent stabilometric platform, corresponds to the average speed of oscillations during standing
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Before the intervention (T0) and at the end of the intervention (T1)
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Functional strength of lower limbs (physical capacities)
Délai: Before the intervention (T0) and at the end of the intervention (T1)
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It is measured via the "Five Sit-to-Stand" clinical test, which measures the time to perform five movements consisting of standing up and sitting down as quickly as possible from a chair.
A shorter time reflects better functional performance
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Before the intervention (T0) and at the end of the intervention (T1)
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Muscular endurance (physical capacities)
Délai: Before the intervention (T0) and at the end of the intervention (T1)
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It corresponds to the ability to sustain muscular effort for a long period.
It is measured using the One-Minute Sit-to-Stand test, which involves standing up and sitting down in a chair as many times as possible within one minute.
A higher number of repetitions indicates better performance.
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Before the intervention (T0) and at the end of the intervention (T1)
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Cardiorespiratory capacities
Délai: Before the intervention (T0) and at the end of the intervention (T1)
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It is assessed via a test onsisting of performing ascents and descents of a step at a prescribed pace over a prolonged period.
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Before the intervention (T0) and at the end of the intervention (T1)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Olivier GUERIN, Pr, Centre Hospitalier Universitaire De Nice
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
5 mai 2026
Achèvement primaire (Estimé)
5 mai 2028
Achèvement de l'étude (Estimé)
5 mai 2028
Dates d'inscription aux études
Première soumission
8 avril 2026
Première soumission répondant aux critères de contrôle qualité
7 mai 2026
Première publication (Réel)
12 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 mai 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 25-PP-26
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .