Long-Term Engagement and Motivation Through Innovative Strategies in Adapted Physical Activity (IMPULSION)
IMPULSION: Long-Term Engagement and Motivation Through Innovative Strategies in Adapted Physical Activity
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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: FREDERIC CHORIN, PhD
- Número de telefone: +33 492034924
- E-mail: chorin.f@chu-nice.fr
Estude backup de contato
- Nome: VIRGINIE PIOVANO
- Número de telefone: +33 492034194
- E-mail: piovano.v@chu-nice.fr
Locais de estudo
-
-
-
Nice, França
- CHU de Nice - Hopital de Cimiez
-
Contato:
- FREDERIC CHORIN, PhD
- Número de telefone: +33 0492034924
- E-mail: chorin.f@chu-nice.fr
-
Contato:
- Virginie PIOVANO
- E-mail: piovano.v@chu-nice.fr
-
Investigador principal:
- Olivier GUERIN, Professor
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age 60 or older
- Affiliation with, or beneficiary of, a social security system
- No objection to the study
Exclusion Criteria:
- 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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: group A
autonomy arm and classical practice
|
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
|
|
Experimental: group B
autonomy arm and TEMPA practice
|
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 |
|
Experimental: group C
non-autonomy arm and classical practice
|
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.
|
|
Experimental: group D
non-autonomy arm and TEMPA practice
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
effectiveness of different Adapted Physical Activity (APA) programs
Prazo: at 12 months
|
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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Analyze functional outcomes: strength
Prazo: at 3 months, and 6 months and 12 months
|
Strength: time to complete the Five Sit-to-Stand test
|
at 3 months, and 6 months and 12 months
|
|
perceptual and motivational factors of engagement
Prazo: at base line and at 3 months
|
EMAPS questionnaires: The Motivation Scale for Physical Activity for Health Purposes (EMAPS) is a tool that assesses individuals' motivations and engagement in physical activity.
It measures intrinsic and extrinsic motivation, based on 7 main constructs: achievement, knowledge and stimulation, external, introjected and identified regulations, and amotivation.
The scale includes 28 statements, each measured on a 1 to 7-point scale, thus allowing a precise assessment of participants' motivations.
|
at base line and at 3 months
|
|
perceptual and motivational factors of engagement
Prazo: at base line and at 3 months
|
PES questionnaire: The Physical Effort Scale (PES) is a tool designed to measure the approach and avoidance tendencies towards physical effort.
It is used to understand the engagement in physical activity.
The scale consists of two factors: approach and avoidance, with each factor having a high internal consistency.
The PES-FR has been shown to be valid for measuring individual differences in physical effort evaluation and has implications for promoting physical activity.
|
at base line and at 3 months
|
|
perceptual and motivational factors of engagement
Prazo: at baseline and at 3 months
|
PANES questionnaire: PANES is a 17-item, self-administered questionnaire that assesses environmental factors in physical activity participation, such as neighborhood safety, aesthetic qualities, neighborhood infrastructure, and access to destinations
|
at baseline and at 3 months
|
|
Analyze functional outcomes: Muscular endurance
Prazo: at 3 months, and 6 months and 12 months
|
Muscular endurance: time to complete the One-Minute Sit-to-Stand test
|
at 3 months, and 6 months and 12 months
|
|
Analyze functional outcomes: Gait analysis
Prazo: at 3 months, and 6 months and 12 months
|
Gait analysis: walking speed over 10 meters
|
at 3 months, and 6 months and 12 months
|
|
Analyze functional outcomes: Balance
Prazo: at 3 months, and 6 months and 12 months
|
Balance: stabilometric measurements
|
at 3 months, and 6 months and 12 months
|
|
Analyze functional outcomes: Body composition
Prazo: at 3 months, and 6 months and 12 months
|
Body composition: bioelectrical impedance analysis
|
at 3 months, and 6 months and 12 months
|
|
Analyze functional outcomes: Cardiorespiratory endurance
Prazo: at 3 months, and 6 months and 12 months
|
Cardiorespiratory endurance: VO₂ max and Harvard index assessed via the Harvard Step Test
|
at 3 months, and 6 months and 12 months
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 25-PP-27
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .