Reducing Fall Risk Post Hip Fracture in Mild Cognitive Impairment

University of British Columbia60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Change in Physiological Profile Assessment

A measure of fall risk (z-score).

Time frame: Baseline to 6 Months

Secondary Outcomes

Change in Short Physical Performance Battery

A measure of balance and mobility (out of 12 points).

Time frame: Baseline to 3 Months and 6 Months

Change in Usual Gait Speed

Gait speed over 4 meters (m/s).

Time frame: Baseline to 3 Months and 6 Months

Change in Life Space Assessment

Mobility within a life-space level.

Time frame: Baseline to 3 Months and 6 Months

Change in NIH Cognitive Toolbox

Cognitive performance of executive functions.

Time frame: Baseline to 3 Months and 6 Months

Change in Digit Symbol Substitute Test

Cognitive performance of processing speed.

Time frame: Baseline to 3 Months and 6 Months

Change in Center for Epidemiological Studies Depression Scale

Mood

Time frame: Baseline to 3 Months and 6 Months

Change in Positive and Negative Affect Scale

Mood

Time frame: Baseline to 3 Months and 6 Months

Change in EQ-5D-5L

Quality of Life

Time frame: Baseline to 3 Months and 6 Months

Change in ICE-CAP

Wellbeing

Time frame: Baseline to 3 Months and 6 Months

Change in Physical Activity for the Elderly

Physical activity over the last 7 days

Time frame: Monthly from Baseline to 6 Months

Total Number of Prospective Falls

Self-report of falls using calendars

Time frame: Monthly from Baseline to 6 Months

Change in Activities Specific Balance Confidence

Fall-related self efficacy

Time frame: 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.

Time frame: Baseline to 3 Months

Change in Timed Up and Go Test

A measure of functional mobility; greater time for completion indicate poorer performance.

Time frame: Baseline to 3 Months and 6 Months

Change in Fried Frailty

A measure of physical frailty

Time frame: Baseline to 3 Months and 6 Months

Change in Clinical Frailty Scale

A measure of frailty; higher value indicate more frailty

Time frame: Baseline to 3 Months and 6 Months

Change in Pittsburgh Sleep Quality Index

A measure of subjective sleep quality

Time frame: Baseline to 3 Month and 6 Months

Change in Rey Auditory Verbal Learning

A measure of episodic memory; higher scores indicate bettter episodic performance.

Time frame: Baseline to 3 Month and 6 Months

Reducing Fall Risk Post Hip Fracture in Mild Cognitive Impairment

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes