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Completed

NCT Number: NCT04748354

Reducing Fall Risk 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Vancouver, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Otago Exercise Program

Behavioral

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

Other names: Exercise

Usual Care

Other

Clinical care provided by a geriatrician.

Primary outcomes

  1. Change in Physiological Profile Assessment

    Time frame: Baseline to 6 Months

    A measure of fall risk (z-score).

Secondary outcomes

  1. Change in Short Physical Performance Battery

    Time frame: Baseline to 3 Months and 6 Months

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

  2. Change in Usual Gait Speed

    Time frame: Baseline to 3 Months and 6 Months

    Gait speed over 4 meters (m/s).

  3. Change in Life Space Assessment

    Time frame: Baseline to 3 Months and 6 Months

    Mobility within a life-space level.

  4. Change in NIH Cognitive Toolbox

    Time frame: Baseline to 3 Months and 6 Months

    Cognitive performance of executive functions.

  5. Change in Digit Symbol Substitute Test

    Time frame: Baseline to 3 Months and 6 Months

    Cognitive performance of processing speed.

  6. Change in Center for Epidemiological Studies Depression Scale

    Time frame: Baseline to 3 Months and 6 Months

    Mood

  7. Change in Positive and Negative Affect Scale

    Time frame: Baseline to 3 Months and 6 Months

    Mood

  8. Change in EQ-5D-5L

    Time frame: Baseline to 3 Months and 6 Months

    Quality of Life

  9. Change in ICE-CAP

    Time frame: Baseline to 3 Months and 6 Months

    Wellbeing

  10. Change in Physical Activity for the Elderly

    Time frame: Monthly from Baseline to 6 Months

    Physical activity over the last 7 days

  11. Total Number of Prospective Falls

    Time frame: Monthly from Baseline to 6 Months

    Self-report of falls using calendars

  12. Change in Activities Specific Balance Confidence

    Time frame: Baseline to 3 Months and 6 Months

    Fall-related self efficacy

  13. Change in Physiological Profile Assessment

    Time frame: Baseline to 3 Months

    A measure of fall risk (z-score); higher z scores indicate higher risk of falls.

  14. Change in Timed Up and Go Test

    Time frame: Baseline to 3 Months and 6 Months

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

  15. Change in Fried Frailty

    Time frame: Baseline to 3 Months and 6 Months

    A measure of physical frailty

  16. Change in Clinical Frailty Scale

    Time frame: Baseline to 3 Months and 6 Months

    A measure of frailty; higher value indicate more frailty

  17. Change in Pittsburgh Sleep Quality Index

    Time frame: Baseline to 3 Month and 6 Months

    A measure of subjective sleep quality

  18. Change in Rey Auditory Verbal Learning

    Time frame: Baseline to 3 Month and 6 Months

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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Amgen

Registry information

Official study title

Reshaping the Path Post Hip Fracture in Mild Cognitive Impairment

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 10, 2021
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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