- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07582406
Codesign, Physical Activity, and Seniors (CAPS)
7 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Olivier GUERIN, Pr
- Número de teléfono: +33 492034194
- Correo electrónico: guerin.o@chu-nice.fr
Ubicaciones de estudio
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Nice, Francia
- Chu De Nice
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Contacto:
- Virginie PIOVANO
- Número de teléfono: +33 492034194
- Correo electrónico: piovano.v@chu-nice.fr
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Maintenance of physical activity
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Stages of behavior change according to the transtheoretical model of behavior change
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Olivier GUERIN, Pr, Centre Hospitalier Universitaire De Nice
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
5 de mayo de 2026
Finalización primaria (Estimado)
5 de mayo de 2028
Finalización del estudio (Estimado)
5 de mayo de 2028
Fechas de registro del estudio
Enviado por primera vez
8 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de mayo de 2026
Publicado por primera vez (Actual)
12 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de mayo de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 25-PP-26
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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