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Reducing Fall Risk Post Hip Fracture in Mild Cognitive Impairment

Primary Purpose

Hip Fractures, Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Otago Exercise Program
Usual Care
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hip Fractures focused on measuring Mobility, Exercise, Fall Risk

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of British ColumbiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care

Usual Care with Exercise

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in Physiological Profile Assessment
A measure of fall risk (z-score).

Secondary Outcome Measures

Change in Short Physical Performance Battery
A measure of balance and mobility (out of 12 points).
Change in Usual Gait Speed
Gait speed over 4 meters (m/s).
Change in Life Space Assessment
Mobility within a life-space level.
Change in NIH Cognitive Toolbox
Cognitive performance of executive functions.
Change in Digit Symbol Substitute Test
Cognitive performance of processing speed.
Change in Center for Epidemiological Studies Depression Scale
Mood
Change in Positive and Negative Affect Scale
Mood
Change in EQ-5D-5L
Quality of Life
Change in ICE-CAP
Wellbeing
Change in Physical Activity for the Elderly
Physical activity over the last 7 days
Total Number of Prospective Falls
Self-report of falls using calendars
Change in Activities Specific Balance Confidence
Fall-related self efficacy
Change in Physiological Profile Assessment
A measure of fall risk (z-score); higher z scores indicate higher risk of falls.
Change in Timed Up and Go Test
A measure of functional mobility; greater time for completion indicate poorer performance.
Change in Fried Frailty
A measure of physical frailty
Change in Pittsburgh Sleep Quality Index
A measure of subjective sleep quality
Change in Rey Auditory Verbal Learning
A measure of episodic memory; higher scores indicate bettter episodic performance.

Full Information

First Posted
February 1, 2021
Last Updated
September 23, 2023
Sponsor
University of British Columbia
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT04748354
Brief Title
Reducing Fall Risk Post Hip Fracture in Mild Cognitive Impairment
Official Title
Reshaping the Path Post Hip Fracture in Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Mild Cognitive Impairment
Keywords
Mobility, Exercise, Fall Risk

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Usual care vs. Usual Care with Exercise
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Clinical care provided by geriatricians. Each participant will see the geriatrician at baseline and 6 months.
Arm Title
Usual Care with Exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Otago Exercise Program
Other Intervention Name(s)
Exercise
Intervention Description
An individualized and home-based program of progressive strength and balance training exercises delivered by a physical therapist
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Clinical care provided by a geriatrician.
Primary Outcome Measure Information:
Title
Change in Physiological Profile Assessment
Description
A measure of fall risk (z-score).
Time Frame
Baseline to 6 Months
Secondary Outcome Measure Information:
Title
Change in Short Physical Performance Battery
Description
A measure of balance and mobility (out of 12 points).
Time Frame
Baseline to 3 Months and 6 Months
Title
Change in Usual Gait Speed
Description
Gait speed over 4 meters (m/s).
Time Frame
Baseline to 3 Months and 6 Months
Title
Change in Life Space Assessment
Description
Mobility within a life-space level.
Time Frame
Baseline to 3 Months and 6 Months
Title
Change in NIH Cognitive Toolbox
Description
Cognitive performance of executive functions.
Time Frame
Baseline to 3 Months and 6 Months
Title
Change in Digit Symbol Substitute Test
Description
Cognitive performance of processing speed.
Time Frame
Baseline to 3 Months and 6 Months
Title
Change in Center for Epidemiological Studies Depression Scale
Description
Mood
Time Frame
Baseline to 3 Months and 6 Months
Title
Change in Positive and Negative Affect Scale
Description
Mood
Time Frame
Baseline to 3 Months and 6 Months
Title
Change in EQ-5D-5L
Description
Quality of Life
Time Frame
Baseline to 3 Months and 6 Months
Title
Change in ICE-CAP
Description
Wellbeing
Time Frame
Baseline to 3 Months and 6 Months
Title
Change in Physical Activity for the Elderly
Description
Physical activity over the last 7 days
Time Frame
Monthly from Baseline to 6 Months
Title
Total Number of Prospective Falls
Description
Self-report of falls using calendars
Time Frame
Monthly from Baseline to 6 Months
Title
Change in Activities Specific Balance Confidence
Description
Fall-related self efficacy
Time Frame
Baseline to 3 Months and 6 Months
Title
Change in Physiological Profile Assessment
Description
A measure of fall risk (z-score); higher z scores indicate higher risk of falls.
Time Frame
Baseline to 3 Months
Title
Change in Timed Up and Go Test
Description
A measure of functional mobility; greater time for completion indicate poorer performance.
Time Frame
Baseline to 3 Months and 6 Months
Title
Change in Fried Frailty
Description
A measure of physical frailty
Time Frame
Baseline to 3 Months and 6 Months
Title
Change in Pittsburgh Sleep Quality Index
Description
A measure of subjective sleep quality
Time Frame
Baseline to 3 Month and 6 Months
Title
Change in Rey Auditory Verbal Learning
Description
A measure of episodic memory; higher scores indicate bettter episodic performance.
Time Frame
Baseline to 3 Month and 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teresa Liu-Ambrose, PhD
Phone
6046178047
Email
teresa.ambrose@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Liu-Ambrose, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Larry Dian, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer C Davis, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deborha Jehu, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre Guy, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Doherty, BA
Phone
604-875-4111
Ext
69313
Email
Stephanie.Doherty@hiphealth.ca
First Name & Middle Initial & Last Name & Degree
Teresa Liu-Ambrose, Ph.D, PT

12. IPD Sharing Statement

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Reducing Fall Risk Post Hip Fracture in Mild Cognitive Impairment

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