Reducing Fall Risk Post Hip Fracture in Mild Cognitive Impairment

NCT04748354 | Completed DMC

• 1 other identifier: H19-03812
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures; Mild Cognitive Impairment

Keywords

Mobility; Exercise; Fall Risk

Outcome Measures

Primary Outcomes (1)

• Change in Physiological Profile Assessment

  A measure of fall risk (z-score).

  Baseline to 6 Months

Secondary Outcomes (18)

• Change in Short Physical Performance Battery

  Baseline to 3 Months and 6 Months

• Change in Usual Gait Speed

  Baseline to 3 Months and 6 Months

• Change in Life Space Assessment

  Baseline to 3 Months and 6 Months

• Change in NIH Cognitive Toolbox

  Baseline to 3 Months and 6 Months

• Change in Digit Symbol Substitute Test

  Baseline to 3 Months and 6 Months

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

Usual Care with Exercise

EXPERIMENTAL

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

Otago Exercise Program BEHAVIORAL

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

Also known as: Exercise

Usual Care with Exercise

Usual Care OTHER

Clinical care provided by a geriatrician.

Usual Care; Usual Care with Exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

Sponsors & Collaborators

• University of British Columbia: lead
• Amgen: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Hip Fractures; Cognitive Dysfunction; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Teresa Liu-Ambrose, PhD

  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

  PRINCIPAL INVESTIGATOR

• Pierre Guy, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessor and study investigators are blinded to group allocation of participants. Participant cannot be blinded due to the nature of the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Usual care vs. Usual Care with Exercise

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 10, 2021
• Study Start: May 3, 2021
• Primary Completion: March 30, 2024
• Study Completion: May 9, 2024
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

CA (1)