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NCT Number: NCT07582406

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.

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Key information

Conditions

Aging

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Co-designed tailored physical activity program

Other

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 program

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. Walking capacities (physical capacities)

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

    Walking speed (meter/sec)

  7. 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

  8. 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

  9. Muscular endurance (physical capacities)

    Time frame: 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.

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Olivier GUERIN, Pr

CONTACT

[email protected]

+33 492034194

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Codesign, Physical Activity and Seniors

Acronym: CAPS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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