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Not yet recruiting NCT07582406

Codesign, Physical Activity, and Seniors

No phase Interventional Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Co-designed tailored physical activity program, Classical tailored physical activity program.
Who it may be relevant to
Registry conditions: Aging. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Codesign, Physical Activity and Seniors

Overview

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.

Interventions

  • Other 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.
  • Other 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.

Primary outcome measures

  • Maintenance of physical activity [Time frame: 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.]
Secondary outcome measures (10)
  • 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)]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU de Nice — Nice

Identifiers

NCT: NCT07582406 · 25-PP-26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗