- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07582406
Codesign, Physical Activity, and Seniors (CAPS)
7 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
60
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Olivier GUERIN, Pr
- Numero di telefono: +33 492034194
- Email: guerin.o@chu-nice.fr
Luoghi di studio
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Nice, Francia
- CHU de Nice
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Contatto:
- Virginie PIOVANO
- Numero di telefono: +33 492034194
- Email: piovano.v@chu-nice.fr
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Maintenance of physical activity
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Stages of behavior change according to the transtheoretical model of behavior change
Lasso di tempo: 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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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Olivier GUERIN, Pr, Centre Hospitalier Universitaire de Nice
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
5 maggio 2026
Completamento primario (Stimato)
5 maggio 2028
Completamento dello studio (Stimato)
5 maggio 2028
Date di iscrizione allo studio
Primo inviato
8 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
7 maggio 2026
Primo Inserito (Effettivo)
12 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 maggio 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 25-PP-26
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .