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Идёт набор NCT05642260

Effects of Fall Prevention Program on the Number of Falls Among Elderly Following Total Knee Replacement

Без фазы С лечением Fall Osteo Arthritis Knee Total Knee Replacement

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: fall prevention programe.
Кому может быть актуально
Состояния в реестре: Fall, Osteo Arthritis Knee, Total Knee Replacement. Базовые параметры: от 60 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Кувейт
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Short- and Long-term Effects of Fall Prevention Program on the Number of Falls Among Elderly Following Total Knee Replacement: a Pragmatic Single-blinded Randomized Controlled Trial.

Обзор

the aim of the proposed research is to investigate the short and long-term effects of integrating a comprehensive fall prevention programme into conventional physiotherapy on the number of falls, balance, and functional ability among elderly following TKR. the investigator hypothesize that conventional physiotherapy integrated with a fall prevention program is more effective than conventional physiotherapy alone in improving balance and functional ability and preventing the occurrence of falls among elderly following TKR. Study type: The proposed study is a parallel group prospective (24 weeks) randomised single-blinded pragmatic controlled trial. Participants: Older adults operated for TKR at Al-Razi orthopedic hospital, who met the inclusion criteria.

Подробное описание

Falls constitute a serious and common threat to the health and well-being of older individuals, and this threat increases with aging. Falls in older individuals place a significant burden on the health care system as well as the caregivers (i.e., family). Importantly, however, many falls could be prevented.

Osteoarthritis (OA) of the knee is a common degenerative musculoskeletal condition among elderly that results in ambulatory dysfunction. This progressive degenerative disorder is usually associated with pain, muscle weakness, and poor balance, all of which are considered primary risk factors for falling among older adults. Total knee replacement (TKR) is the most replicable and effective orthopaedic procedure used to treat advanced-stage knee OA. The goal of TKR is to relieve pain, increase knee mobility, and improve functional ability and the overall quality of life. Despite the promising results of TKR surgery, it is associated with a high prevalence of falls. In this regard, falls rate have been reported to be between 6.2% and 42.6% in the first 12 months following TKR. Persistence of muscle weakness and poor balance may contribute to the high fall rate following TKR. This highlights the importance of targeting muscle strength and balance during rehabilitation, considering the short-term implications that could reflect on long-term recovery.

A substantial amount of evidence supports the use of exercise-based interventions (i.e., muscle strengthening and balance training) to prevent falls and fall-related injuries. A Cochrane systematic review by on 108 RCTs (n=23,407) provided high-certainty evidence that exercises, particularly balance and functional based-exercises, are more effective in reducing the falls rate compared to the control interventions. Moreover, exercise-based interventions have been shown to be superior to other interventions for mitigating age-related decline and reducing falls and falls-related injuries with the least harm and greatest cost-effectiveness.

Conventional physiotherapy following TKR involves, primarily, strengthening and knee range of motion exercises and gait re-education. However, there is a lack of balance training/exercises in the rehabilitation program. Given the high prevalence of falls following TKR, integrating a comprehensive fall prevention program into conventional physiotherapy may be of importance. Thus, the aim of the proposed research is to investigate the short and long-term effects of integrating a comprehensive fall prevention programme into conventional physiotherapy on the number of falls, balance, and functional ability among elderly following TKR.

Вмешательства

  • Другое fall prevention programe
    Patients in the experimental group will receive a comprehensive fall prevention program (guided by the post-TKR protocol followed at Al-Razi Orthopedic Hospital) into the conventional physiotherapy treatment

Первичные конечные точки

  • falls rate [Срок оценки: baseline]
  • falls rate [Срок оценки: 12 weeks]
  • falls rate [Срок оценки: 1 year]
Вторичные конечные точки (6)
  • Knee range of motion (ROM) [Срок оценки: baseline]
  • Knee range of motion (ROM) [Срок оценки: 12 weeks]
  • Patient's satisfaction [Срок оценки: 12 weeks]
  • Patient's satisfaction [Срок оценки: 1 year]
  • Adherence: [Срок оценки: 12 weeks]
  • Adherence: [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Female gender.
  • Aged 60 years and older.
  • Diagnosed with primary osteoarthritis of the knee.
  • Underwent unilateral TKR.

Критерии исключения

  • revision TKR surgery
  • history of systemic inflammatory conditions (i.e., rheumatoid arthritis, Lupus erythematosus),
  • neurological disorders (i.e., multiple sclerosis, Parkinson's disease, stroke)
  • lower limb surgery/trauma in the past 12 months
  • have cognitive and/or vision impairments
  • post-surgical complications (e.g., infection, intraoperative fracture)
  • any health condition that may preclude them from undertaking physiotherapy.

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
Простое слепое
Основная цель
Профилактика

Центры проведения

Кувейт · 1 центр
  • Alrazi orthopedic hospital — Kuwait City

Публикации

  • Al-Saleh H, Merza E, Al-Adwanie B, Pearson S, Malliaras P. The short- and long-term effects of a fall prevention program on the frequency of falls following total knee replacement: A pragmatic single-blinded randomized controlled trial protocol. Contemp Clin Trials. 2025 Mar;150:107837. doi: 10.1016/j.cct.2025.107837. Epub 2025 Feb 6. PMID 39921156

Идентификаторы

NCT: NCT05642260 · 2146/2022

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗