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Набор скоро начнётся NCT07741513

Balance Workshops Focusing on Learning to Stand Up From the Floor for Older Adults Living at Home: A Pilot Study Sol'Up

Без фазы С лечением Balance Control in Elderly Fall Prevention

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: Balance Workshops, "getting up from the floor" module.
Кому может быть актуально
Состояния в реестре: Balance Control in Elderly, Fall Prevention. Базовые параметры: от 65 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

Balance Workshops Focusing on Learning to Stand Up From the Floor for Older Adults Living at Home: A Pilot Study - Sol'Up

Обзор

Falls among older adults are a major public health issue, accounting for approximately 2 million incidents annually in France, resulting in more than 10,000 deaths and 130,000 hospitalizations. Their cost is estimated at nearly 2 billion euros per year and is expected to rise as the population ages. Falls result from multiple factors, including biological, behavioral, and environmental factors, with balance and gait disorders playing a central role. Their consequences include loss of independence, restricted activity, and fear of falling. The ability to get back up from the ground after a fall is still largely overlooked. Yet up to two-thirds of older adults who have fallen are unable to get up on their own, exposing them to serious complications and an increased risk of further falls. This skill remains under-assessed and under-trained. Physical activity-particularly programs combining balance, muscle strengthening, and functional training-can reduce the risk of falling by approximately 20 to 30 percent. Balance workshops are widely used for this purpose. However, these interventions primarily focus on fall prevention and rarely address fall management, particularly the ability to get up from the floor. Specific interventions targeting this skill are still underdeveloped, with mixed results. The integration of structured training in getting up from the floor into balance workshops

Подробное описание

The primary objective of this study is to explore the feasibility and acceptability of integrating a soil survey training module into a balance workshop program for older adults living at home.

The secondary objectives of this study are to explore the potential effects of the program on certain functional and psychosocial dimensions among participants, by conducting an exploratory comparison between the intervention group and the control group.

The study will aim to assess:

* the ability to get up from the floor; * functional mobility; * functional strength of the lower limbs; * postural balance; * confidence in balance during daily activities; * perceived self-efficacy for getting up from the floor; * level of physical activity; * the number of falls The feasibility of the intervention will be assessed based on the fidelity of its implementation: adherence to the content, the instructional progression, and the duration of the scheduled sessions. This aspect will be evaluated by the research team using a standardized monitoring form completed by the physical therapists.

The acceptability of the intervention will be assessed based on the following factors:

* Participants' satisfaction with the program, as measured by a satisfaction questionnaire administered at the end of the intervention. * Physical therapists' satisfaction with the program, as measured by a satisfaction questionnaire administered at the end of the intervention. * Program adherence, assessed by the session attendance rate (number of sessions attended relative to the total number of sessions offered) as well as the dropout rate during the program.

The secondary outcome measures aim to explore the potential impact of the intervention by comparing the intervention group and the control group. Measurements will be taken at the beginning of the program (T0) and at the end (T1) regarding:

* Ability to stand up from the floor, assessed using a standardized floor-to-standing test, which evaluates the level of assistance required (0: cannot stand up, 1: with assistance, 2: without assistance) and the time required to stand up. * Functional mobility, assessed using the Timed Up and Go (TUG) test: * Functional strength of the lower limbs, assessed using the Five-Time Sit-to-Stand Test (FTSST) * Postural balance, assessed using the Romberg test, the tandem stance test, and the single-leg stance test. * Confidence in balance during daily activities (Activities-specific Balance Confidence Scale (ABC)) * Perceived self-efficacy for getting up from the floor, assessed via a direct question (scale from 0 to 10). * Level of physical activity, assessed using a validated self-administered questionnaire (International Physical Activity Questionnaire - Short Form, IPAQ-SF). * Number of falls and circumstances

The criteria assessed via questionnaire (balance confidence during daily activities, perceived self-efficacy for getting up from the floor, level of physical activity, number of falls) will also be assessed by telephone 12 weeks after the intervention (T2).

Вмешательства

  • Другое Balance Workshops
    Participants take part in the standard program, which includes one-hour group sessions designed to improve balance, mobility, coordination, muscle strength, confidence in moving around, and fall-prevention behaviors. The sessions include: * static and dynamic balance exercises; * muscle-strengthening exercises; * coordination and dual-task exercises; * joint mobility exercises; * educational sessions on physical activity, the environment, nutrition, and fall prevention; * discussion and wrap-u
  • Другое "getting up from the floor" module
    This 20 minutes module includes a safe progression covering: * lower-body mobility, particularly the ankles, knees, and hips; * weight shifts; * gradual transitions to the floor; * exercises in intermediate positions: lunge, knight's stance, all fours; * strategies for turning and moving on the floor; * learning to transition from the floor to a standing position; * identifying secure points of support; * managing apprehension; * applying what has been learned to everyday situations. Progressio

Первичные конечные точки

  • Feasibility of the intervention [Срок оценки: 6 months]
  • Feasibility of the intervention [Срок оценки: 6 months]
  • Feasibility of the intervention [Срок оценки: 6 months]
  • Acceptability of the intervention [Срок оценки: 6 months]
  • Acceptability of the intervention [Срок оценки: 6 months]
  • Acceptability of the intervention [Срок оценки: 6 months]
Вторичные конечные точки (8)
  • Ability to stand up from the floor [Срок оценки: at the beginning of the program (T0) and at the end (T1)]
  • Functional mobility [Срок оценки: at the beginning of the program (T0) and at the end (T1)]
  • Functional lower-limb strength [Срок оценки: at the beginning of the program (T0) and at the end (T1)]
  • Postural balance [Срок оценки: at the beginning of the program (T0) and at the end (T1)]
  • Confidence in balance during daily activities [Срок оценки: at the beginning of the program (T0) and at the end (T1)]
  • Perceived self-efficacy for getting up from the floor [Срок оценки: at the beginning of the program (T0) and at the end (T1)]
  • Level of physical activity [Срок оценки: at the beginning of the program (T0) and at the end (T1)]
  • Number of falls [Срок оценки: at the beginning of the program (T0) and at the end (T1)]

Критерии участия

Критерии включения

  • People over the age of 65
  • Able to walk 100 m independently, with or without a walking aid (1 cane or 1 crutch)
  • Individuals who have fallen at least once in the past 12 months
  • Individuals who feel unsteady while standing or walking
  • Individuals who express a fear of falling
  • Individuals enrolled in the social security system or a similar program
  • Individuals who have been informed and have given their written consent to participate in the study

Критерии исключения

  • Refusal to participate in the study
  • Individuals who walk with two canes or a walker, or who are unable to walk
  • Medical contraindications to physical activity (cardiac conditions, acute illness, uncompensated vestibular disorder).
  • Major cognitive impairment or dementia preventing active participation.
  • Individuals with other contraindications, at the investigator's discretion
  • Recent orthopedic surgery (<3 months).
  • Major uncompensated sensory impairment

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Франция · 1 центр
  • Association KPAURA RHONE — Valence

Идентификаторы

NCT: NCT07741513 · RIPH2-BIGEARD-SOLUP · 2026-A01178-43

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗