NCT07596056

Brief Summary

Aging is associated with progressive declines in physical, functional, and psychosocial capacities, leading to reduced autonomy, increased risk of falls, chronic diseases, and decreased quality of life. Physical inactivity is a major aggravating factor, despite strong evidence that regular physical activity helps prevent age-related decline. Adapted Physical Activity (APA) has demonstrated beneficial effects on physical function, mental health, pain, and healthcare utilization. However, long-term adherence to APA programs among older adults remains low, with fewer than 20% meeting World Health Organization recommendations. Therefore, innovative strategies are needed to improve sustained engagement in physical activity. This multicenter, randomized, single-blind interventional study aims to compare the effectiveness of different APA strategies on long-term engagement in physical activity among adults aged 60 years and older. A total of 600 participants will be randomized into four groups combining two key factors: (1) autonomy-based vs. non-autonomy-based approaches, and (2) classical APA vs. TEMPA-based APA programs. Each intervention consists of a 12-week program including 24 supervised sessions, with some groups incorporating a progressive transition toward autonomous practice. The primary outcome is long-term physical activity engagement assessed using the QAPPA questionnaire at baseline, 6 months, and 12 months. Secondary outcomes include: Objective and self-reported physical activity levels (questionnaires and wearable devices) Functional capacities (muscle strength, endurance, gait speed, balance, cardiorespiratory fitness) Motivational and perceptual factors (e.g., enjoyment, fatigue, perceived effort, motivation) Quality of life (EQ-5D-5L) Biological markers (inflammatory, metabolic, metabolomic, and epigenetic profiles) to identify predictors of adherence and physiological response Cost-effectiveness and cost-utility analyses (incremental cost-effectiveness ratio) Statistical analyses will be conducted using mixed linear models for repeated measures to evaluate time, group, and interaction effects. Additional analyses will include descriptive statistics, group comparisons, longitudinal trends, and economic evaluations. This study aims to identify effective and sustainable APA strategies to improve long-term physical activity engagement and inform public health policies for older adults.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
61mo left

Started Sep 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2031

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

5 years

First QC Date

May 5, 2026

Last Update Submit

May 12, 2026

Conditions

Keywords

Adapted Physical Activityaging

Outcome Measures

Primary Outcomes (1)

  • effectiveness of different Adapted Physical Activity (APA) programs

    The primary objective of this study is to compare the effectiveness of different Adapted Physical Activity (APA) programs on long-term engagement in physical activity among older adults. Long-term engagement will be assessed through the level of physical activity, measured using the QAPPA questionnaire The Physical Activity Questionnaire for Older Adults (QAPPA) is a tool for measuring the physical activity of people aged 60 and over. It was developed to meet the objective of assessing the level of physical activity of older adults, taking into account their age and health.

    at 12 months

Secondary Outcomes (9)

  • Analyze functional outcomes: strength

    at 3 months, and 6 months and 12 months

  • perceptual and motivational factors of engagement

    at base line and at 3 months

  • perceptual and motivational factors of engagement

    at base line and at 3 months

  • perceptual and motivational factors of engagement

    at baseline and at 3 months

  • Analyze functional outcomes: Muscular endurance

    at 3 months, and 6 months and 12 months

  • +4 more secondary outcomes

Study Arms (4)

group A

EXPERIMENTAL

autonomy arm and classical practice

Other: Group A autonomy arm and classical practice

group B

EXPERIMENTAL

autonomy arm and TEMPA practice

Other: GROUP B autonomy arm and TEMPA practice

group C

EXPERIMENTAL

non-autonomy arm and classical practice

Other: Group C non-autonomy arm and classical practice

group D

EXPERIMENTAL

non-autonomy arm and TEMPA practice

Other: Group D non-autonomy arm and TEMPA practice

Interventions

All participants in Group A will receive a total of 24 Adapted Physical Activity (APA) sessions delivered by a qualified APA professional over a 15-week period. Two sessions per week will be provided during the first 9 weeks. From week 10 to week 15, only one supervised in-person session per week will be offered, and participants will be asked to complete the second session independently. This transition in session planning is expected to promote more sustainable long-term engagement in physical activity, Each session will consist of a warm-up (approximately 10-15 minutes), a main exercise phase (including endurance, strength, balance, flexibility, and coordination exercises), and a cool-down period. The structure of the sessions will be consistent and will comply with physical activity prescription guidelines for older adults

group A

In Group B, sessions will more explicitly incorporate effort minimization strategies (TEMPA), which will be clearly communicated to participants. These strategies include encouraging focus on perceived enjoyment during exercise, allowing participants to choose music, involving participants in leading warm-ups, integrating game-based activities (e.g., dodgeball-type games), strengthening group cohesion and sense of affiliation, and providing individualized feedback on performance during sessions. To ensure proper implementation, the instructor will receive specific training in the TEMPA theoretical model and its associated adaptations. The instructor will also be required to explicitly communicate the strategies used during sessions. A report documenting the strategies implemented will be completed by the instructor after each session

group B

All participants in Group C will receive a total of 24 Adapted Physical Activity (APA) sessions delivered by a qualified APA professional over a 12-week period. Participants will attend two APA sessions per week.

group C

In Group D, sessions will more explicitly incorporate effort minimization strategies (TEMPA), which will be clearly communicated to participants. These strategies include encouraging participants to focus on perceived enjoyment during exercise, allowing them to choose music, involving them in leading the warm-up, integrating game-based activities (e.g., dodgeball-type games), strengthening group cohesion and sense of affiliation, and providing individualized feedback on performance during sessions.

group D

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 60 or older
  • Affiliation with, or beneficiary of, a social security system
  • No objection to the study

You may not qualify if:

  • Neurocognitive disorder preventing the provision of informed consent (MOCA \<18)
  • Individuals under legal protection
  • Individuals deprived of liberty
  • Presence of a physical or cognitive condition preventing participation in the adapted physical activity protocol over 3 months:
  • Neurocognitive disorder (MOCA \<18)
  • Neurodegenerative disease with severe symptoms preventing participation in the protocol
  • Neuromuscular disease with severe symptoms preventing participation in the protocol
  • Severe sensory impairments (blindness or profound deafness)
  • Amputation of one or more limbs
  • Non-independent mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice - Hopital de Cimiez

Nice, France

Location

Central Study Contacts

FREDERIC CHORIN, PhD

CONTACT

VIRGINIE PIOVANO

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 19, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2031

Study Completion (Estimated)

September 1, 2031

Last Updated

May 19, 2026

Record last verified: 2026-05

Locations