- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07582406
Codesign, Physical Activity, and Seniors (CAPS)
May 7, 2026 updated by: 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Olivier GUERIN, Pr
- Phone Number: +33 492034194
- Email: guerin.o@chu-nice.fr
Study Locations
-
-
-
Nice, France
- CHU de Nice
-
Contact:
- Virginie PIOVANO
- Phone Number: +33 492034194
- Email: piovano.v@chu-nice.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maintenance of physical activity
Time Frame: 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
Time Frame: Through intervention completion, for 12 weeks.
|
Adherence corresponds to attendance rates at physical activity sessions during the program.
|
Through intervention completion, for 12 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stages of behavior change according to the transtheoretical model of behavior change
Time Frame: 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
Time Frame: 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)
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Decisionnal balance according to the transtheoretical model of behavior change
Time Frame: 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)
|
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Self-efficacy according to the transtheoretical model of behavior change
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
|
|
Balance (physical capacities)
Time Frame: 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)
|
|
Functional strength of lower limbs (physical capacities)
Time Frame: 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
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Before the intervention (T0) and at the end of the intervention (T1)
|
|
Muscular endurance (physical capacities)
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Olivier GUERIN, Pr, Centre Hospitalier Universitaire de Nice
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 5, 2026
Primary Completion (Estimated)
May 5, 2028
Study Completion (Estimated)
May 5, 2028
Study Registration Dates
First Submitted
April 8, 2026
First Submitted That Met QC Criteria
May 7, 2026
First Posted (Actual)
May 12, 2026
Study Record Updates
Last Update Posted (Actual)
May 12, 2026
Last Update Submitted That Met QC Criteria
May 7, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 25-PP-26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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