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Not yet recruitingNCT07582406CAPSUpdated May 12, 2026

Codesign, Physical Activity, and Seniors

An interventional study of Co-designed tailored physical activity program and Classical tailored physical activity program in Aging, sponsored by Centre Hospitalier Universitaire de Nice. Not yet recruiting at 1 site in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Aging
03

In context

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Co-designed tailored physical activity program

    Other: Co-designed tailored physical activity program

  • Active comparator
    Classical tailored physical activity program

    Other: Classical tailored physical activity program

Interventions

  • OtherCo-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.

  • OtherClassical 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months and 1 year after the end of the intervention (T2, T3)

  2. Adherence of physical activity program

    Adherence corresponds to attendance rates at physical activity sessions during the program.

    Time frame: Through intervention completion, for 12 weeks.

Secondary outcomes

  1. 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)

    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)

  2. 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.

    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)

  3. 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.

    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)

  4. 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.

    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)

  5. Body composition

    Composition in lean mass and fat mass. It will assessed by dual-energy X-ray absorptiometry (DXA).

    Time frame: Before the intervention (T0) and at the end of the intervention (T1)

  6. Walking capacities (physical capacities)

    Walking speed (meter/sec)

    Time frame: Before the intervention (T0) and at the end of the intervention (T1)

  7. Balance (physical capacities)

    Postural balance, assessed using a K-Invent stabilometric platform, corresponds to the average speed of oscillations during standing

    Time frame: Before the intervention (T0) and at the end of the intervention (T1)

  8. 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

    Time frame: Before the intervention (T0) and at the end of the intervention (T1)

  9. 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.

    Time frame: Before the intervention (T0) and at the end of the intervention (T1)

  10. 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.

    Time frame: Before the intervention (T0) and at the end of the intervention (T1)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07582406
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
May 12, 2026
Start date
May 5, 2026 (estimated)
Primary completion
May 5, 2028 (estimated)
Completion
May 5, 2028 (estimated)
Last update
May 12, 2026

Study contacts

Olivier GUERIN, Pr
Contact
guerin.o@chu-nice.fr
+33 492034194
Olivier GUERIN, Pr
principal investigator · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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