Preventing Falls in Older Adults With Cognitive Frailty
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 and Strength Training Exercises with Health Coaching, Education Session.
- Кому может быть актуально
- Состояния в реестре: Falls, Frailty, Mild Cognitive Impairment. Базовые параметры: 65 лет — 89 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
- Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
ACTIVE: Adding Life to Years in Cognitive Frailty by Preventing Falls
Обзор
The Problem: The proposed trial will address the problem of how to effectively prevent subsequent falls in community-dwelling cognitively frail older adults with a history of falls. Primary Question: In community-dwelling older adults with cognitive frailty and a history of falls, can a home-based exercise program with behavioural change techniques significantly reduce falls vs. health education (i.e., control; CON)?
Подробное описание
Rationale: Falls are a significant cause of functional decline and often a sentinel event. Older adults with cognitive frailty - those with concurrent physical frailty and mild cognitive impairment - are at particular risk for falls. Notably, falls can cause a sudden and severe change in their health state from one of independence to one of dependence. Thus, effective falls prevention strategies need to be identified for older adults with cognitive frailty.
The Otago Exercise Program (OEP) - a physical therapist (PT) delivered home-based exercise program - is an evidence-based falls prevention program for community-dwelling older adults. Our pilot data show the OEP vs. usually care significantly reduced subsequent falls in 192 community-dwelling older adults with cognitive frailty and a history of falls; the incident rate ratio was 0.64 (95% CI, 0.43-0.98; P = .042). These preliminary findings need to be confirmed in a rigorously designed RCT powered for falls in older adults with cognitive frailty; none exist to date.
We also observed lower OEP adherence among older adults with cognitive frailty vs. those without cognitive frailty. Thus, strategies to support adherence must be considered in RCTs of exercise to prevent falls in this high-risk population. Evidence-based strategies include health coaching.
Thus, we propose a 12-month multi-site randomized controlled trial (RCT) in older adults with cognitive frailty and a history of falls to assess the efficacy of the OEP combined with health coaching (i.e., OEP+) to prevent falls.
Primary Question: In community-dwelling older adults with cognitive frailty and a history of falls, can the OEP+ significantly reduce falls vs. health education (i.e., control; CON)?
Secondary Questions: 1) What are additional benefits of the OEP+ vs. CON? 2) Do the benefits of OEP+ persist 6 months post cessation? 3) Can the OEP+ reduce falls or improve quality of life at similar or lower costs vs. CON?
Methods: A 12-month assessor-blinded, multi-site RCT, with a 6-month follow-up, in older adults, with cognitive frailty - defined by a Short Physical Performance Battery score \< 9/12 and a Montreal Cognitive Assessment score between 18-25/30 - and a history of falls. Participants will be randomized to either: a) OEP+ or b) CON. The OEP+ intervention will include Brief Action Planning-based health coaching. The CON group will include monthly interactive education sessions via Zoom. Measurement will occur at baseline, 6, 12, and 18 months, with falls tracked daily.
Вмешательства
- Поведенческое Balance and Strength Training Exercises with Health Coaching
The OEP+ intervention integrates the OEP with health coaching by a physical therapists or kinesiologist. The OEP is an individualized home-based balance and strength exercise training program delivered by a PT or kinesiologist coach over 5 home visits. - Другое Education Session
All active comparator participants will be invited to join monthly interactive social and education sessions via Zoom or in-person (hybrid delivery).
Первичные конечные точки
- Falls [Срок оценки: Daily tracking over 12 months]
Вторичные конечные точки (12)
- Short Physical Performance Battery [Срок оценки: Baseline, 6 months, 12 months, 18 months]
- Montreal Cognitive Assessment [Срок оценки: Baseline, 6 months, 12 months, 18 months]
- Falls during followup period [Срок оценки: Daily tracking from 12 months (trial completion) to end of 6-month followup (18 months)]
- NIH Cognitive Toolbox [Срок оценки: Baseline, 6 months, 12 months, 18 months]
- Processing speed [Срок оценки: Baseline, 6 months, 12 months, 18 months]
- Memory [Срок оценки: Baseline, 6 months, 12 months, 18 months]
- Gait Speed [Срок оценки: Baseline, 6 months, 12 months, 18 months]
- Muscle Strength [Срок оценки: Baseline, 6 months, 12 months, 18 months]
- Community Mobility [Срок оценки: Baseline, 6 months, 12 months, 18 months]
- Functional Mobility [Срок оценки: Baseline, 6 months, 12 months, 18 months]
- Fatigue [Срок оценки: Baseline, 6 months, 12 months, 18 months]
- Quality of Life [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months]
Критерии участия
Критерии включения
- We will include individuals who: 1) are aged 70 to 89 years\*; 2) live in Greater Vancouver; 3) are community-dwelling (i.e., not residing in a nursing home or extended care unit); 4) experienced a non-syncopal fall in the prior 12 months; 5) scored < 9/12 on the SPPB; 6) have subjective cognitive complaints based on interview; 7) scored 18-25/30 on the MoCA; 8) are able to walk independently; use of cane is acceptable; 9) are able to safely engage in exercise as indicated by the Physical Activity Readiness Questionnaire Plus (PAR-Q+) and confirmed by their physician; 10) have internet at home; and 11) are able to provide written informed consent.
- The age maximum of 89 was set due to the increased risk of significant adverse health outcomes cognitively frail older adults face. As this population has an increased risk of falls, functional disability with loss of independence, hospitalization, and death, setting an age maximum aims to increase the likelihood that participants will be able to complete the 18-month study without interruptions due to health complications. This age limit has been reviewed and approved by CIHR.
Критерии исключения
- We will exclude those who are: 1) diagnosed with dementia, as measured by a Clinical Dementia Rating (CDR) score above 0.5, a neurodegenerative disease, or stroke; 2) self-report engaging in strength training and/or balance training exercises > 2 times per week, in the prior 3 months; or 3) unable to understand, speak, and read English proficiently.
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
- Тройное слепое
- Основная цель
- Профилактика
Центры проведения
Канада · 1 центр
- Centre for Aging SMART at VCH, University of BC — Vancouver
Идентификаторы
NCT: NCT06854731 · H23-01584