Reshaping the Path Post Hip Fracture in Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Physiological Profile Assessment
研究概览
简要总结
Hip fracture is recognized as one of the most serious consequences of osteoporosis, less than half regain pre-fracture independence. 95% of all hip fractures in older adults are due to falls. Thus, reducing fall risk while restoring function post-hip fracture is critical. Many with fall-related hip fractures have cognitive impairment; cognitive impairment increases the risk of falls. The purpose of this 6-month proof-of-concept randomized controlled trial (RCT) is to assess the efficacy of the home-based Otago Exercise Program (OEP) compared with usual care in reducing fall risk among older adults with mild cognitive impairment (MCI) and a fall-related hip fracture.
详细描述
Hip fracture is recognized as one of the most serious consequences of osteoporosis, less than half regain pre-fracture independence. 95% of all hip fractures in older adults are due to falls. Thus, reducing fall risk while restoring function post-hip fracture is critical. Many with fall-related hip fractures have cognitive impairment and they are less likely to regain pre-fracture level of function than those without cognitive impairment. Cognitive impairment also increase falls risk. It is currently unknown whether exercise is efficacious in reducing fall risk and promoting function among older adults with mild cognitive impairment (MCI) and a fall-related hip fracture. The purpose of this 6-month proof-of-concept RCT is to assess the efficacy of the home-based Otago Exercise Program (OEP) compared with usual care in reducing fall risk among community-dwelling older adults with MCI and a fall-related hip fracture.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Assessor and study investigators are blinded to group allocation of participants. Participant cannot be blinded due to the nature of the intervention.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 65 or older; 2) sustained a fall-related hip fracture in the last 12 months and have returned home; 3) have preserved general cognition as indicated by a Mini-Mental State Examination (MMSE) score = or > 20/30; 4) have subjective memory complaints, determined by interview;22 5) score < 26/30 on the Montreal Cognitive Assessment (MoCA); 6) have an absence of significant functional impairment and no dementia as determined by a physician; 7) are not expected to start, or are stable (i.e., > 3 months) on a fixed dose of anti-dementia medications (e.g., donepezil, galantamine) during the RCT; 8) are expected to live > 12 months (based on the geriatricians' expert opinion); 9) can read, write, and speak English with acceptable visual and auditory acuity; 10) are able to walk 3 meters with or without an assistive device; and 1) provide written informed consent.
排除标准
- •diagnosed with or suspected to have (by the geriatrician) a neurodegenerative disease (e.g., Parkinson's disease) or dementia; 2) had a clinical stroke; or 3) have a history indicative of carotid sinus sensitivity (i.e., syncopal falls).
结局指标
主要结局
Change in Physiological Profile Assessment
时间窗: Baseline to 6 Months
A measure of fall risk (z-score).
次要结局
- Change in Fried Frailty(Baseline to 3 Months and 6 Months)
- Change in Clinical Frailty Scale(Baseline to 3 Months and 6 Months)
- Change in Pittsburgh Sleep Quality Index(Baseline to 3 Month and 6 Months)
- Change in Rey Auditory Verbal Learning(Baseline to 3 Month and 6 Months)
- Change in Short Physical Performance Battery(Baseline to 3 Months and 6 Months)
- Change in Usual Gait Speed(Baseline to 3 Months and 6 Months)
- Change in Life Space Assessment(Baseline to 3 Months and 6 Months)
- Change in NIH Cognitive Toolbox(Baseline to 3 Months and 6 Months)
- Change in Digit Symbol Substitute Test(Baseline to 3 Months and 6 Months)
- Change in Center for Epidemiological Studies Depression Scale(Baseline to 3 Months and 6 Months)
- Change in Positive and Negative Affect Scale(Baseline to 3 Months and 6 Months)
- Change in ICE-CAP(Baseline to 3 Months and 6 Months)
- Change in Physical Activity for the Elderly(Monthly from Baseline to 6 Months)
- Total Number of Prospective Falls(Monthly from Baseline to 6 Months)
- Change in Activities Specific Balance Confidence(Baseline to 3 Months and 6 Months)
- Change in Physiological Profile Assessment(Baseline to 3 Months)
- Change in Timed Up and Go Test(Baseline to 3 Months and 6 Months)
- Change in Short Physical Performance Battery(Baseline to 3 Months and 6 Months)
- Change in Usual Gait Speed(Baseline to 3 Months and 6 Months)
- Change in Life Space Assessment(Baseline to 3 Months and 6 Months)
- Change in NIH Cognitive Toolbox(Baseline to 3 Months and 6 Months)
- Change in Digit Symbol Substitute Test(Baseline to 3 Months and 6 Months)
- Change in Center for Epidemiological Studies Depression Scale(Baseline to 3 Months and 6 Months)
- Change in Positive and Negative Affect Scale(Baseline to 3 Months and 6 Months)
- Change in EQ-5D-5L(Baseline to 3 Months and 6 Months)
- Change in ICE-CAP(Baseline to 3 Months and 6 Months)
- Change in Physical Activity for the Elderly(Monthly from Baseline to 6 Months)
- Total Number of Prospective Falls(Monthly from Baseline to 6 Months)
- Change in Activities Specific Balance Confidence(Baseline to 3 Months and 6 Months)
- Change in Physiological Profile Assessment(Baseline to 3 Months)
- Change in Timed Up and Go Test(Baseline to 3 Months and 6 Months)
- Change in Fried Frailty(Baseline to 3 Months and 6 Months)
- Change in Clinical Frailty Scale(Baseline to 3 Months and 6 Months)
- Change in Pittsburgh Sleep Quality Index(Baseline to 3 Month and 6 Months)
- Change in Rey Auditory Verbal Learning(Baseline to 3 Month and 6 Months)
研究者
Teresa Liu-Ambrose
Professor
University of British Columbia