- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07582406
Codesign, Physical Activity, and Seniors (CAPS)
7 mei 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
60
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Olivier GUERIN, Pr
- Telefoonnummer: +33 492034194
- E-mail: guerin.o@chu-nice.fr
Studie Locaties
-
-
-
Nice, Frankrijk
- Chu De Nice
-
Contact:
- Virginie PIOVANO
- Telefoonnummer: +33 492034194
- E-mail: piovano.v@chu-nice.fr
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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).
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Actieve vergelijker: Classical tailored physical activity program
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Maintenance of physical activity
Tijdsspanne: 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.
|
6 months and 1 year after the end of the intervention (T2, T3)
|
|
Adherence of physical activity program
Tijdsspanne: Through intervention completion, for 12 weeks.
|
Adherence corresponds to attendance rates at physical activity sessions during the program.
|
Through intervention completion, for 12 weeks.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Stages of behavior change according to the transtheoretical model of behavior change
Tijdsspanne: 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
Tijdsspanne: 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.
|
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)
|
|
Decisionnal balance according to the transtheoretical model of behavior change
Tijdsspanne: 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.
|
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 according to the transtheoretical model of behavior change
Tijdsspanne: 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)
|
|
Body composition
Tijdsspanne: 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).
|
Before the intervention (T0) and at the end of the intervention (T1)
|
|
Walking capacities (physical capacities)
Tijdsspanne: Before the intervention (T0) and at the end of the intervention (T1)
|
Walking speed (meter/sec)
|
Before the intervention (T0) and at the end of the intervention (T1)
|
|
Balance (physical capacities)
Tijdsspanne: 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
|
Before the intervention (T0) and at the end of the intervention (T1)
|
|
Functional strength of lower limbs (physical capacities)
Tijdsspanne: Before the intervention (T0) and at the end of the intervention (T1)
|
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
|
Before the intervention (T0) and at the end of the intervention (T1)
|
|
Muscular endurance (physical capacities)
Tijdsspanne: 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.
|
Before the intervention (T0) and at the end of the intervention (T1)
|
|
Cardiorespiratory capacities
Tijdsspanne: Before the intervention (T0) and at the end of the intervention (T1)
|
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)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Olivier GUERIN, Pr, Centre Hospitalier Universitaire De Nice
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
5 mei 2026
Primaire voltooiing (Geschat)
5 mei 2028
Studie voltooiing (Geschat)
5 mei 2028
Studieregistratiedata
Eerst ingediend
8 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
7 mei 2026
Eerst geplaatst (Werkelijk)
12 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
12 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
7 mei 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 25-PP-26
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .