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Набор скоро начнётся NCT07596056

Long-Term Engagement and Motivation Through Innovative Strategies in Adapted Physical Activity

Без фазы С лечением Aging, Healthy Aging

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Group A autonomy arm and classical practice, GROUP B autonomy arm and TEMPA practice, Group C non-autonomy arm and classical practice, Group D non-autonomy arm and TEMPA practice.
Кому может быть актуально
Состояния в реестре: Aging, Healthy, Aging. Базовые параметры: от 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

IMPULSION: Long-Term Engagement and Motivation Through Innovative Strategies in Adapted Physical Activity

Обзор

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.

Вмешательства

  • Другое 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
  • Другое 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.
  • Другое 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.
  • Другое 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 sessio

Первичные конечные точки

  • effectiveness of different Adapted Physical Activity (APA) programs [Срок оценки: at 12 months]
Вторичные конечные точки (9)
  • Analyze functional outcomes: strength [Срок оценки: at 3 months, and 6 months and 12 months]
  • perceptual and motivational factors of engagement [Срок оценки: at base line and at 3 months]
  • perceptual and motivational factors of engagement [Срок оценки: at base line and at 3 months]
  • perceptual and motivational factors of engagement [Срок оценки: at baseline and at 3 months]
  • Analyze functional outcomes: Muscular endurance [Срок оценки: at 3 months, and 6 months and 12 months]
  • Analyze functional outcomes: Gait analysis [Срок оценки: at 3 months, and 6 months and 12 months]
  • Analyze functional outcomes: Balance [Срок оценки: at 3 months, and 6 months and 12 months]
  • Analyze functional outcomes: Body composition [Срок оценки: at 3 months, and 6 months and 12 months]
  • Analyze functional outcomes: Cardiorespiratory endurance [Срок оценки: at 3 months, and 6 months and 12 months]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

Франция · 1 центр
  • CHU de Nice - Hopital de Cimiez — Nice

Идентификаторы

NCT: NCT07596056 · 25-PP-27

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗