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Набор по приглашению NCT07564076

Comparison of the Effects of Different Exercise Protocols in Frail Elderly Individuals

Без фазы С лечением Frail Elderly

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: Vivifrail Exercise Program, Otago Exercise Program.
Кому может быть актуально
Состояния в реестре: Frail Elderly. 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

Comparison of the Effects of Different Exercise Programs on Fall Risk, Fall Fear, and Physical Performance in Frail Geriatric Individuals

Обзор

The aim of this research is to investigate and compare the effects of two different exercise programs developed for frail geriatric individuals on fall risk, fear of falling, and physical performance.

Подробное описание

Frailty is a syndrome characterized by a decline across multiple physiological systems associated with aging. It results in diminished physiological reserve and increased vulnerability to stressors, leading to limitations in activities of daily living. This condition is closely linked to adverse outcomes, including falls, illness, hospitalization, and mortality. The frailty phenotype is generally defined by five criteria: weight loss, exhaustion, low grip strength, slowness, and reduced physical activity. The presence of three or more of these criteria indicates frailty, while one or two criteria signify a pre-frail state. Research indicates that frail geriatric individuals face a significantly higher risk of falling compared to their non-frail peers. Furthermore, a heightened fear of falling is associated with an increased risk of frailty. Consequently, prioritizing frailty management in geriatric care is essential for mitigating fall risks.

Exercise interventions have been shown to produce positive effects on physical function and quality of life in frail older adults. By improving muscle mass and strength, exercise plays a pivotal role in the treatment of frailty. Various exercise programs specifically designed as fall prevention strategies are recommended for this population. Notably, the frailty status of elderly individuals residing in nursing homes requires greater clinical attention compared to those living in the community. Nursing home residents often exhibit lower physical activity levels and a higher need for structured exercise interventions. Investigating and comparing the effectiveness of different exercise programs for this vulnerable group is crucial for selecting the most efficient protocols to reduce fall risks and enhance physical performance.

The Otago Exercise Program (OEP) is a well-established, evidence-based fall prevention protocol frequently utilized in geriatric care. It comprises warming up, progressive strengthening and balance exercises, walking sessions, and aerobic components. OEP has the potential to delay or even reverse frailty while improving the overall health status of participants. Current evidence suggests that OEP can reduce frailty, increase grip strength, and improve balance and mobility in frail and pre-frail individuals, although its impact on quality of life remains less certain. Despite its widespread use, there is a need for more robust study designs to confirm its efficacy, particularly regarding its effects on the fear of falling, where existing research is limited.

In addition, multicomponent exercise programs-which integrate strengthening, balance, aerobic, and flexibility training within a single session-are considered a viable and effective alternative for geriatric populations. Such programs are recommended as part of routine clinical practice for frail or sedentary individuals. A prominent example is the Vivifrail project, developed by international experts to provide personalized exercise prescriptions for preventing frailty and falls. In the Vivifrail program, the exercise regimen is tailored to the individual's functional status and fall risk, encompassing strength, balance, flexibility, and cardiovascular endurance. Studies have demonstrated that Vivifrail can reverse functional decline associated with hospitalization and improve functional capacity in older women with dynapenia as well as in frail individuals with mild cognitive impairment. The program is noted for its ease of implementation, offering a quick assessment to guide exercise prescription.

Currently, there is a paucity of research regarding the impact of the Vivifrail program on fall risk and the fear of falling in frail geriatric individuals. Similarly, further high-quality studies are required to fully establish the benefits of OEP in this population. Furthermore, there is a notable gap in the literature regarding direct comparisons between the Vivifrail and Otago programs. Therefore, this study is designed to investigate and compare the effects of these two distinct exercise protocols on fall risk, fear of falling, and physical performance among frail geriatric individuals residing in nursing homes.

Вмешательства

  • Другое Vivifrail Exercise Program
    Following an initial assessment and random assignment to exercise groups, participants will undergo a multicomponent exercise program (Vivifrail) consisting of 60 sessions, 5 days a week, for 12 weeks. Each session will last approximately 60 minutes and will be conducted on two non-consecutive days with a physiotherapist present, and on the other three days following instructions given by the physiotherapist and patient education. The program will be supervised by the institution's physician, wh
  • Другое Otago Exercise Program
    The Otago Exercise Program (OEP) consists of balance and strengthening exercises and walking exercises. Each exercise session in the OEP begins with 5-7 minutes of light warm-up exercises and continues with approximately 30-35 minutes of strengthening and balance exercises. Additionally, participants are included in moderate-paced walking sessions for 30 minutes at least twice a week on days when the exercise program is not in progress. The number of repetitions, frequency, intensity, and durati

Первичные конечные точки

  • Mini-BESTest: Balance Evaluation Systems Test [Срок оценки: two weeks]
  • Falls Efficacy Scale [Срок оценки: two weeks]
  • Short Physical Performance Battery (SPPB) [Срок оценки: two weeks]
Вторичные конечные точки (3)
  • Fear of Falling Questionnaire Revised (FFQ-R) [Срок оценки: two weeks]
  • The Four Square Step Test (FSST) [Срок оценки: two weeks]
  • Nottingham Health Profile [Срок оценки: two weeks]

Критерии участия

Критерии включения

  • Volunteering to participate in the study
  • Having been diagnosed as frail according to Fried Frail Phenotype (3 or more criteria)
  • Being able to walk with or without a walking aid

Критерии исключения

  • Being in the terminal stage of illness
  • Presence of cognitive impairment (Mini Mental State Assessment score below 24)
  • Severe vision and hearing loss
  • Acute myocardial infarction (within the last 3-6 months) or unstable angina;
  • Uncontrolled atrial or ventricular arrhythmias;
  • Aortic dissection aneurysm;
  • Severe aortic stenosis;
  • Acute endocarditis/pericarditis;
  • Uncontrolled high blood pressure (> 180/100 mmHg);
  • Acute thromboembolism;
  • Acute or severe heart failure;
  • Acute or severe respiratory failure;
  • Uncontrolled postural hypotension;
  • Uncontrolled acute decompensated diabetes or low blood sugar;
  • History of fracture within the last 3 months

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
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Marmara University — Istanbul

Идентификаторы

NCT: NCT07564076 · MU-FTR-OSK-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗