University of British Columbia
Vancouver, British Columbia, Canada
NCT Number: NCT04748354
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.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Vancouver, British Columbia, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
1) 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.
Exclusion criteria
1) 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).
An individualized and home-based program of progressive strength and balance training exercises delivered by a physical therapist
Other names: Exercise
Clinical care provided by a geriatrician.
Time frame: Baseline to 6 Months
A measure of fall risk (z-score).
Time frame: Baseline to 3 Months and 6 Months
A measure of balance and mobility (out of 12 points).
Time frame: Baseline to 3 Months and 6 Months
Gait speed over 4 meters (m/s).
Time frame: Baseline to 3 Months and 6 Months
Mobility within a life-space level.
Time frame: Baseline to 3 Months and 6 Months
Cognitive performance of executive functions.
Time frame: Baseline to 3 Months and 6 Months
Cognitive performance of processing speed.
Time frame: Baseline to 3 Months and 6 Months
Mood
Time frame: Baseline to 3 Months and 6 Months
Mood
Time frame: Baseline to 3 Months and 6 Months
Quality of Life
Time frame: Baseline to 3 Months and 6 Months
Wellbeing
Time frame: Monthly from Baseline to 6 Months
Physical activity over the last 7 days
Time frame: Monthly from Baseline to 6 Months
Self-report of falls using calendars
Time frame: Baseline to 3 Months and 6 Months
Fall-related self efficacy
Time frame: Baseline to 3 Months
A measure of fall risk (z-score); higher z scores indicate higher risk of falls.
Time frame: Baseline to 3 Months and 6 Months
A measure of functional mobility; greater time for completion indicate poorer performance.
Time frame: Baseline to 3 Months and 6 Months
A measure of physical frailty
Time frame: Baseline to 3 Months and 6 Months
A measure of frailty; higher value indicate more frailty
Time frame: Baseline to 3 Month and 6 Months
A measure of subjective sleep quality
Time frame: Baseline to 3 Month and 6 Months
A measure of episodic memory; higher scores indicate bettter episodic performance.
University of British Columbia
Other
Reshaping the Path Post Hip Fracture in Mild Cognitive Impairment
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