Hip Fractures, Mild Cognitive Impairment
Conditions
Keywords
Mobility, Exercise, Fall Risk
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.
Interventions
BEHAVIORALOtago Exercise Program
An individualized and home-based program of progressive strength and balance training exercises delivered by a physical therapist
OTHERUsual Care
Clinical care provided by a geriatrician.
Sponsors
Amgen
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Assessor and study investigators are blinded to group allocation of participants. Participant cannot be blinded due to the nature of the intervention.
Intervention model description
Usual care vs. Usual Care with Exercise
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physiological Profile Assessment | Baseline to 6 Months | A measure of fall risk (z-score). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Short Physical Performance Battery | Baseline to 3 Months and 6 Months | A measure of balance and mobility (out of 12 points). |
| 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; higher value indicate more 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. |
| Change in Physical Activity for the Elderly | Monthly from Baseline to 6 Months | Physical activity over the last 7 days |
Countries
Canada
Outcome results
None listed