Reducing Fall Risk Post Hip Fracture in Mild Cognitive Impairment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reshaping the Path Post Hip Fracture in Mild Cognitive Impairment

Conditions
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Hip Fractures, Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Otago Exercise Program
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Usual care vs. Usual Care with Exercise
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Clinical care provided by geriatricians. Each participant will see the geriatrician at baseline and 6 months. | Other: Usual Care<br>* Clinical care provided by a geriatrician.<br>|
| Experimental: Usual Care with Exercise<br>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. | Behavioral: Otago Exercise Program<br>* An individualized and home-based program of progressive strength and balance training exercises delivered by a physical therapist<br>* Other names: Exercise;Other: Usual Care<br>* Clinical care provided by a geriatrician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physiological Profile Assessment | A measure of fall risk (z-score). | Baseline to 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short Physical Performance Battery | A measure of balance and mobility (out of 12 points). | Baseline to 3 Months and 6 Months | 
| Change in Usual Gait Speed | Gait speed over 4 meters (m/s). | Baseline to 3 Months and 6 Months | 
| Change in Life Space Assessment | Mobility within a life-space level. | Baseline to 3 Months and 6 Months | 
| Change in NIH Cognitive Toolbox | Cognitive performance of executive functions. | Baseline to 3 Months and 6 Months | 
| Change in Digit Symbol Substitute Test | Cognitive performance of processing speed. | Baseline to 3 Months and 6 Months | 
| Change in Center for Epidemiological Studies Depression Scale | Mood | Baseline to 3 Months and 6 Months | 
| Change in Positive and Negative Affect Scale | Mood | Baseline to 3 Months and 6 Months | 
| Change in EQ-5D-5L | Quality of Life | Baseline to 3 Months and 6 Months | 
| Change in ICE-CAP | Wellbeing | Baseline to 3 Months and 6 Months | 
| Change in Physical Activity for the Elderly | Physical activity over the last 7 days | Monthly from Baseline to 6 Months | 
| Total Number of Prospective Falls | Self-report of falls using calendars | Monthly from Baseline to 6 Months | 
| Change in Activities Specific Balance Confidence | Fall-related self efficacy | Baseline to 3 Months and 6 Months | 
| Change in Physiological Profile Assessment | A measure of fall risk (z-score); higher z scores indicate higher risk of falls. | Baseline to 3 Months | 
| Change in Timed Up and Go Test | A measure of functional mobility; greater time for completion indicate poorer performance. | Baseline to 3 Months and 6 Months | 
| Change in Fried Frailty | A measure of physical frailty | Baseline to 3 Months and 6 Months | 
| Change in Pittsburgh Sleep Quality Index | A measure of subjective sleep quality | Baseline to 3 Month and 6 Months | 
| Change in Rey Auditory Verbal Learning | A measure of episodic memory; higher scores indicate bettter episodic performance. | Baseline to 3 Month and 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobility, Exercise, Fall Risk