Reducing Fall Risk Post Hip Fracture in Mild Cognitive Impairment

Reshaping the Path Post Hip Fracture in Mild Cognitive Impairment

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hip Fractures; Mild Cognitive Impairment
• Intervention / Treatment: Other: Usual Care; Behavioral: Otago Exercise Program

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Teresa Liu-Ambrose, PhD; Phone Number: 6046178047; Email: teresa.ambrose@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • University of British Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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 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 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 Short Physical Performance Battery	A measure of balance and mobility (out of 12 points).	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 Rey Auditory Verbal Learning	A measure of episodic memory; higher scores indicate bettter episodic performance.	Baseline to 3 Month and 6 Months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Amgen
• Investigators: Principal Investigator: Teresa Liu-Ambrose, PhD, University of British Columbia; Principal Investigator: Pierre Guy, MD, 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

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 6, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Mobility; Fall Risk
• Additional Relevant MeSH Terms: Mental Disorders; Wounds and Injuries; Neurocognitive Disorders; Leg Injuries; Cognition Disorders; Femoral Fractures; Hip Injuries; Cognitive Dysfunction; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: H19-03812

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No