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CompletedNCT04748354Updated Nov 24, 2025

Reducing Fall Risk Post Hip Fracture in Mild Cognitive Impairment

An interventional study of Otago Exercise Program and Usual Care in Hip Fractures and Mild Cognitive Impairment, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-11-24.

Sponsored by University of British Columbia · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hip Fractures
  • Mild Cognitive Impairment

Keywords

  • Mobility
  • Exercise
  • Fall Risk
03

In context

Hip Fractures

822 studies on the registry are indexed under Hip Fractures; 160 are open to participants now.

This study's enrollment of 60 is below the median of 90 across 529 interventional studies indexed under Hip Fractures.

Browse Hip Fractures studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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).

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Usual Care

    Clinical care provided by geriatricians. Each participant will see the geriatrician at baseline and 6 months.

    Other: Usual Care

  • 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.

    Behavioral: Otago Exercise Program · Other: Usual Care

Interventions

  • BehavioralOtago Exercise Program

    An individualized and home-based program of progressive strength and balance training exercises delivered by a physical therapist

    Also known as: Exercise

  • OtherUsual Care

    Clinical care provided by a geriatrician.

06

What researchers measure

Primary outcomes

  1. Change in Physiological Profile Assessment

    A measure of fall risk (z-score).

    Time frame: Baseline to 6 Months

Secondary outcomes

  1. 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

  2. Change in Usual Gait Speed

    Gait speed over 4 meters (m/s).

    Time frame: Baseline to 3 Months and 6 Months

  3. Change in Life Space Assessment

    Mobility within a life-space level.

    Time frame: Baseline to 3 Months and 6 Months

  4. Change in NIH Cognitive Toolbox

    Cognitive performance of executive functions.

    Time frame: Baseline to 3 Months and 6 Months

  5. Change in Digit Symbol Substitute Test

    Cognitive performance of processing speed.

    Time frame: Baseline to 3 Months and 6 Months

  6. Change in Center for Epidemiological Studies Depression Scale

    Mood

    Time frame: Baseline to 3 Months and 6 Months

  7. Change in Positive and Negative Affect Scale

    Mood

    Time frame: Baseline to 3 Months and 6 Months

  8. Change in EQ-5D-5L

    Quality of Life

    Time frame: Baseline to 3 Months and 6 Months

  9. Change in ICE-CAP

    Wellbeing

    Time frame: Baseline to 3 Months and 6 Months

  10. Change in Physical Activity for the Elderly

    Physical activity over the last 7 days

    Time frame: Monthly from Baseline to 6 Months

  11. Total Number of Prospective Falls

    Self-report of falls using calendars

    Time frame: Monthly from Baseline to 6 Months

  12. Change in Activities Specific Balance Confidence

    Fall-related self efficacy

    Time frame: Baseline to 3 Months and 6 Months

  13. 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

  14. 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

  15. Change in Fried Frailty

    A measure of physical frailty

    Time frame: Baseline to 3 Months and 6 Months

  16. Change in Clinical Frailty Scale

    A measure of frailty; higher value indicate more frailty

    Time frame: Baseline to 3 Months and 6 Months

  17. Change in Pittsburgh Sleep Quality Index

    A measure of subjective sleep quality

    Time frame: Baseline to 3 Month and 6 Months

  18. 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

07

Study locations

1 site
  • University of British Columbia
    Vancouver, British Columbia, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04748354
Lead sponsor
University of British Columbia
Collaborators
Amgen
Responsible party
Teresa Liu-Ambrose (Professor, University of British Columbia) — Principal investigator
First posted
Feb 10, 2021
Start date
May 3, 2021
Primary completion
Mar 30, 2024
Completion
May 9, 2024
Last update
Nov 24, 2025

Study contacts

Teresa Liu-Ambrose, PhD
principal investigator · University of British Columbia
Larry Dian, MD
principal investigator · University of British Columbia
Jennifer C Davis, PhD
principal investigator · University of British Columbia
Deborha Jehu, PhD
principal investigator · University of British Columbia
Pierre Guy, MD
principal investigator · University of British Columbia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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