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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Clinical care provided by geriatricians. Each participant will see the geriatrician at baseline and 6 months. |
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| Usual Care with Exercise | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Otago Exercise Program | Behavioral | An individualized and home-based program of progressive strength and balance training exercises delivered by a physical therapist |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Physiological Profile Assessment | A measure of fall risk (z-score). | Baseline to 6 Months |
| 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). |
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Teresa Liu-Ambrose, PhD | University of British Columbia | Principal Investigator |
| Larry Dian, MD | University of British Columbia | Principal Investigator |
| Jennifer C Davis, PhD | University of British Columbia | Principal Investigator |
| Deborha Jehu, PhD | University of British Columbia | Principal Investigator |
| Pierre Guy, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Vancouver | British Columbia | Canada |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D060825 | Cognitive Dysfunction |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Usual care vs. Usual Care with Exercise
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Assessor and study investigators are blinded to group allocation of participants. Participant cannot be blinded due to the nature of the intervention.
|
| Usual Care | Other | Clinical care provided by a geriatrician. |
|
| 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 Clinical Frailty Scale | A measure of frailty; higher value indicate more 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 |
| D007869 |
| Leg Injuries |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |