ACTIVE: Adding Life to Years in Cognitive Frailty by Preventing Falls
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Falls
研究概览
简要总结
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)?
详细描述
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)?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •We will include individuals who meet the following criteria: 1) aged between 65 and 89 years; 2) live in Greater Vancouver, British Columbia; 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 impairment based on interview; 7) scored 18-25/30 on the MoCA [62,64]; 8) are able to walk with or without a gait aid; 9) scored ≥ 6/8 on Lawton and Brody Instrumental Activities of Daily Living Scale (IADL) [65]; 10) are able to safely engage in exercise as indicated by the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) [66]; and 11) are able to understand, speak, and read English with sufficient proficiency to complete the assessments.
- •*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.
排除标准
- •We will exclude individuals who: 1) have been diagnosed with dementia, a neurodegenerative disease, or stroke; 2) report engaging in strength and balance training exercises ≥ 2 times per week in the prior 3 months; 3) have severe depression based on a score of ≥ 11/15 on the GDS.
研究组 & 干预措施
Educational Control
All active control participants will be invited to join monthly interactive education sessions via Zoom or in-person.
干预措施: Education Session (Other)
Otago Exercise Program (OEP) Plus
The OEP+ intervention integrates the OEP with health coaching by a physical therapist 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 and 6 phone check-ins
干预措施: Balance and Strength Training Exercises with Health Coaching (Behavioral)
结局指标
主要结局
Falls
时间窗: Daily tracking over 12 months
The number of self-reported falls during the 12-month intervention period (i.e., rate of falls).
次要结局
- Community Mobility(Baseline, 6 months, 12 months, 18 months)
- NIH Cognitive Toolbox(Baseline, 6 months, 12 months, 18 months)
- Processing speed(Baseline, 6 months, 12 months, 18 months)
- Fatigue(Baseline, 6 months, 12 months, 18 months)
- Quality of Life(Baseline, 3 months, 6 months, 9 months, 12 months, 18 months)
- Physical Frailty(Baseline, 6 months, 12 months, 18 months)
- Physical Activity(Baseline, 6 months, 12 months, 18 months)
- Mood(Baseline, 6 months, 12 months, 18 months)
- Fall Risk(Baseline, 6 months, 12 months, 18 months)
- Frailty Index(Baseline, 6 months, 12 months, 18 months)
- Short Physical Performance Battery(Baseline, 6 months, 12 months, 18 months)
- Montreal Cognitive Assessment(Baseline, 6 months, 12 months, 18 months)
- Falls during followup period(Daily tracking from 12 months (trial completion) to end of 6-month followup (18 months))
- Memory(Baseline, 6 months, 12 months, 18 months)
- Gait Speed(Baseline, 6 months, 12 months, 18 months)
- Muscle Strength(Baseline, 6 months, 12 months, 18 months)
- Functional Mobility(Baseline, 6 months, 12 months, 18 months)
- Fear of Falling(Baseline, 6 months, 12 months, 18 months)
- Health Resource Utilization (HRU)(Baseline, 3 months, 6 months, 9 months, 12 months, 18 months)
- Sleep Quality (Objective) - Optional(Baseline, 6 months, 12 months, 18 months)
- Brain Function - Optional(Baseline, 6 months, 12 months)
研究者
Teresa Liu-Ambrose
Professor
University of British Columbia