- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07582406
Codesign, Physical Activity, and Seniors (CAPS)
7. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Olivier GUERIN, Pr
- Telefonnummer: +33 492034194
- E-post: guerin.o@chu-nice.fr
Studiesteder
-
-
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Nice, Frankrike
- Chu De Nice
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Ta kontakt med:
- Virginie PIOVANO
- Telefonnummer: +33 492034194
- E-post: piovano.v@chu-nice.fr
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Co-designed tailored physical activity program
|
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.
|
|
Aktiv komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maintenance of physical activity
Tidsramme: 6 months and 1 year after the end of the intervention (T2, T3)
|
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
Tidsramme: Through intervention completion, for 12 weeks.
|
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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Stages of behavior change according to the transtheoretical model of behavior change
Tidsramme: 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)
|
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)
|
|
Change process according to the transtheoretical model of behavior change
Tidsramme: 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)
|
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
Tidsramme: 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)
|
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
Tidsramme: 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)
|
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.
|
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
Tidsramme: Before the intervention (T0) and at the end of the intervention (T1)
|
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)
Tidsramme: Before the intervention (T0) and at the end of the intervention (T1)
|
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)
Tidsramme: Before the intervention (T0) and at the end of the intervention (T1)
|
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)
Tidsramme: 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)
Tidsramme: Before the intervention (T0) and at the end of the intervention (T1)
|
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
Tidsramme: 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.
|
Before the intervention (T0) and at the end of the intervention (T1)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Olivier GUERIN, Pr, Centre Hospitalier Universitaire De Nice
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
5. mai 2026
Primær fullføring (Antatt)
5. mai 2028
Studiet fullført (Antatt)
5. mai 2028
Datoer for studieregistrering
Først innsendt
8. april 2026
Først innsendt som oppfylte QC-kriteriene
7. mai 2026
Først lagt ut (Faktiske)
12. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. mai 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 25-PP-26
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