AgingCAPSNCT07582406
Codesign, Physical Activity, and Seniors
A study testing Co-designed tailored physical activity program and Classical tailored physical activity program in people with Aging, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aging
- What is being tested?
- Co-designed tailored physical activity program and Classical tailored physical activity program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2026to 5 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Aging
- Being tested
- Co-designed tailored physical activity program, Classical tailored physical activity program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-designed tailored physical activity programOther
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.
Classical tailored physical activity programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Co-designed tailored physical activity program | Experimental | Not described Receives: Other: Co-designed tailored physical activity program |
| Classical tailored physical activity program | Active comparator | Not described Receives: Other: Classical tailored physical activity program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of physical activity
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.
Measured: 6 months and 1 year after the end of the intervention (T2, T3)
Adherence of physical activity program
Adherence corresponds to attendance rates at physical activity sessions during the program.
Measured: Through intervention completion, for 12 weeks.
Secondary outcomes (10)
Stages of behavior change according to the transtheoretical model of behavior change
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)
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Composition in lean mass and fat mass. It will assessed by dual-energy X-ray absorptiometry (DXA).
Measured: Before the intervention (T0) and at the end of the intervention (T1)
Walking capacities (physical capacities)
Walking speed (meter/sec)
Measured: Before the intervention (T0) and at the end of the intervention (T1)
Balance (physical capacities)
Postural balance, assessed using a K-Invent stabilometric platform, corresponds to the average speed of oscillations during standing
Measured: Before the intervention (T0) and at the end of the intervention (T1)
Functional strength of lower limbs (physical capacities)
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
Measured: Before the intervention (T0) and at the end of the intervention (T1)
Muscular endurance (physical capacities)
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.
Measured: Before the intervention (T0) and at the end of the intervention (T1)
Cardiorespiratory capacities
It is assessed via a test onsisting of performing ascents and descents of a step at a prescribed pace over a prolonged period.
Measured: Before the intervention (T0) and at the end of the intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start2 Sep 2026
- Primary completion7 Sep 2027 (estimated)
- Study completion5 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier GUERIN, Pr, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582406
- Sponsor's protocol ID
- 25-PP-26
- Acronym
- CAPS
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Codesign, Physical Activity and Seniors
- ClinicalTrials.gov ID
- NCT07582406
- Acronym / sponsor ID
- CAPS / 25-PP-26
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- 7 Sep 2027 (estimated)
- Study completion
- 5 May 2028 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Co-designed tailored physical activity program | Experimental | Other: Co-designed tailored physical activity program |
| Classical tailored physical activity program | Active comparator | Other: Classical tailored physical activity program |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Co-designed tailored physical activity programThe '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. | Other | Co-designed tailored physical activity program |
| Classical tailored physical activity programThe '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. | Other | Classical tailored physical activity program |
Primary outcome
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.
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.
10 secondary outcomes
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)
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)
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)
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)
Body composition
Time frame: 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)
Balance (physical capacities)
Time frame: 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)
Muscular endurance (physical capacities)
Time frame: Before the intervention (T0) and at the end of the intervention (T1)
Cardiorespiratory capacities
Time frame: Before the intervention (T0) and at the end of the intervention (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier GUERIN, Pr principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-designed tailored physical activity program and Classical tailored physical activity program in people with Aging, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of physical activity (time frame: 6 months and 1 year after the end of the intervention (T2, T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.