Reducing Fall Risk Post Hip Fracture in Mild Cognitive Impairment
- Conditions
- Hip FracturesMild Cognitive Impairment
- Interventions
- Behavioral: Otago Exercise ProgramOther: Usual Care
- Registration Number
- NCT04748354
- Lead Sponsor
- University of British Columbia
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care with Exercise Usual Care Clinical care provided by geriatricians. Each participant will see the geriatrician at baseline and 6 months. In addition, they will receive the Otago Exercise Program, an individualized and home-based program of progressive strength and balance training exercises delivered by a physical therapist. Usual Care Usual Care Clinical care provided by geriatricians. Each participant will see the geriatrician at baseline and 6 months. Usual Care with Exercise Otago Exercise Program Clinical care provided by geriatricians. Each participant will see the geriatrician at baseline and 6 months. In addition, they will receive the Otago Exercise Program, an individualized and home-based program of progressive strength and balance training exercises delivered by a physical therapist.
- Primary Outcome Measures
Name Time Method Change in Physiological Profile Assessment Baseline to 6 Months A measure of fall risk (z-score).
- Secondary Outcome Measures
Name Time Method Change in Short Physical Performance Battery Baseline to 3 Months and 6 Months A measure of balance and mobility (out of 12 points).
Change in Usual Gait Speed Baseline to 3 Months and 6 Months Gait speed over 4 meters (m/s).
Change in Life Space Assessment Baseline to 3 Months and 6 Months Mobility within a life-space level.
Change in NIH Cognitive Toolbox Baseline to 3 Months and 6 Months Cognitive performance of executive functions.
Change in Digit Symbol Substitute Test Baseline to 3 Months and 6 Months Cognitive performance of processing speed.
Change in Center for Epidemiological Studies Depression Scale Baseline to 3 Months and 6 Months Mood
Change in Positive and Negative Affect Scale Baseline to 3 Months and 6 Months Mood
Change in EQ-5D-5L Baseline to 3 Months and 6 Months Quality of Life
Change in ICE-CAP Baseline to 3 Months and 6 Months Wellbeing
Change in Physical Activity for the Elderly Monthly from Baseline to 6 Months Physical activity over the last 7 days
Total Number of Prospective Falls Monthly from Baseline to 6 Months Self-report of falls using calendars
Change in Activities Specific Balance Confidence Baseline to 3 Months and 6 Months Fall-related self efficacy
Change in Physiological Profile Assessment Baseline to 3 Months A measure of fall risk (z-score); higher z scores indicate higher risk of falls.
Change in Timed Up and Go Test Baseline to 3 Months and 6 Months A measure of functional mobility; greater time for completion indicate poorer performance.
Change in Fried Frailty Baseline to 3 Months and 6 Months A measure of physical frailty
Change in Clinical Frailty Scale Baseline to 3 Months and 6 Months A measure of frailty
Change in Pittsburgh Sleep Quality Index Baseline to 3 Month and 6 Months A measure of subjective sleep quality
Change in Rey Auditory Verbal Learning Baseline to 3 Month and 6 Months A measure of episodic memory; higher scores indicate bettter episodic performance.
Trial Locations
- Locations (1)
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada