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Reducing Fall Risk Post Hip Fracture in Mild Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT04748354
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : August 31, 2022
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Teresa Liu-Ambrose, University of British Columbia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hip Fractures Mild Cognitive Impairment Behavioral: Otago Exercise Program Other: Usual Care Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Usual care vs. Usual Care with Exercise
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Assessor and study investigators are blinded to group allocation of participants. Participant cannot be blinded due to the nature of the intervention.
Primary Purpose: Prevention
Official Title: Reshaping the Path Post Hip Fracture in Mild Cognitive Impairment
Actual Study Start Date : May 3, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Behavioral: Otago Exercise Program
An individualized and home-based program of progressive strength and balance training exercises delivered by a physical therapist
Other Name: Exercise

Other: Usual Care
Clinical care provided by a geriatrician.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Physiological Profile Assessment [ Time Frame: Baseline to 6 Months ]
    A measure of fall risk (z-score).


Secondary Outcome Measures :
  1. Change in Short Physical Performance Batter [ 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. Health Resource Utilization [ Time Frame: Monthly from Baseline to 6 Months ]
    Self-report of health resources

  12. Total Number of Prospective Falls [ Time Frame: Monthly from Baseline to 6 Months ]
    Self-report of falls using calendars

  13. Change in Activities Specific Balance Confidence [ Time Frame: Baseline to 3 Months and 6 Months ]
    Fall-related self efficacy

  14. Change in PROMIS Sleep Disturbance [ Time Frame: Monthly from Baseline to 6 Months ]
    Sleep quality

  15. Change in Physiological Profile Assessment [ Time Frame: Baseline to 3 Months ]
    A measure of fall risk (z-score).


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 > 24/30; 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).

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04748354


Contacts
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Contact: Teresa Liu-Ambrose, PhD 6046178047 teresa.ambrose@ubc.ca

Locations
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Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada
Contact: Stephanie Doherty, BA    604-875-4111 ext 69313    Stephanie.Doherty@hiphealth.ca   
Principal Investigator: Teresa Liu-Ambrose, Ph.D, PT         
Sponsors and Collaborators
University of British Columbia
Amgen
Investigators
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Principal Investigator: 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
More Information
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Responsible Party: Teresa Liu-Ambrose, Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04748354    
Other Study ID Numbers: H19-03812
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: August 31, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teresa Liu-Ambrose, University of British Columbia:
Mobility
Exercise
Fall Risk
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Cognitive Dysfunction
Wounds and Injuries
Cognition Disorders
 Neurocognitive Disorders
Mental Disorders
Femoral Fractures
Hip Injuries
Leg Injuries