Hip FracturesNCT04748354
Reducing Fall Risk Post Hip Fracture in Mild Cognitive Impairment
A study testing Otago Exercise Program in people with Hip Fractures and Mild Cognitive Impairment, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Mild Cognitive Impairment
- What is being tested?
- Otago Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 3 May 2021to 9 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reshaping the Path 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.
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.
- Conditions
- Hip Fractures, Mild Cognitive Impairment
- Being tested
- Otago Exercise Program, Usual Care
- Keywords
- Mobility, Exercise, Fall Risk
- Medical subject headings
- Hip Fractures, Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago Exercise ProgramBehavioural
Also called Exercise
An individualized and home-based program of progressive strength and balance training exercises delivered by a physical therapist
Usual CareOther
Clinical care provided by a geriatrician.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Clinical care provided by geriatricians. Each participant will see the geriatrician at baseline and 6 months. Receives: 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. Receives: Behavioral: Otago Exercise Program; Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physiological Profile Assessment
A measure of fall risk (z-score).
Measured: Baseline to 6 Months
Secondary outcomes (18)
Change in Short Physical Performance Battery
A measure of balance and mobility (out of 12 points).
Measured: Baseline to 3 Months and 6 Months
Change in Usual Gait Speed
Gait speed over 4 meters (m/s).
Measured: Baseline to 3 Months and 6 Months
Change in Life Space Assessment
Mobility within a life-space level.
Measured: Baseline to 3 Months and 6 Months
Change in NIH Cognitive Toolbox
Cognitive performance of executive functions.
Measured: Baseline to 3 Months and 6 Months
Change in Digit Symbol Substitute Test
Cognitive performance of processing speed.
Measured: Baseline to 3 Months and 6 Months
Change in Center for Epidemiological Studies Depression Scale
Mood
Measured: Baseline to 3 Months and 6 Months
Change in Positive and Negative Affect Scale
Mood
Measured: Baseline to 3 Months and 6 Months
Change in EQ-5D-5L
Quality of Life
Measured: Baseline to 3 Months and 6 Months
Change in ICE-CAP
Wellbeing
Measured: Baseline to 3 Months and 6 Months
Change in Physical Activity for the Elderly
Physical activity over the last 7 days
Measured: Monthly from Baseline to 6 Months
Total Number of Prospective Falls
Self-report of falls using calendars
Measured: Monthly from Baseline to 6 Months
Change in Activities Specific Balance Confidence
Fall-related self efficacy
Measured: Baseline to 3 Months and 6 Months
Change in Physiological Profile Assessment
A measure of fall risk (z-score); higher z scores indicate higher risk of falls.
Measured: Baseline to 3 Months
Change in Timed Up and Go Test
A measure of functional mobility; greater time for completion indicate poorer performance.
Measured: Baseline to 3 Months and 6 Months
Change in Fried Frailty
A measure of physical frailty
Measured: Baseline to 3 Months and 6 Months
Change in Clinical Frailty Scale
A measure of frailty; higher value indicate more frailty
Measured: Baseline to 3 Months and 6 Months
Change in Pittsburgh Sleep Quality Index
A measure of subjective sleep quality
Measured: Baseline to 3 Month and 6 Months
Change in Rey Auditory Verbal Learning
A measure of episodic memory; higher scores indicate bettter episodic performance.
Measured: Baseline to 3 Month and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start3 May 2021
- Primary completion30 Mar 2024
- Study completion9 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Usual care vs. Usual Care with Exercise
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Teresa Liu-Ambrose, University of British Columbia
- Investigators
- Teresa Liu-Ambrose, PhD, Principal investigator, University of British ColumbiaLarry Dian, MD, Principal investigator, University of British ColumbiaJennifer C Davis, PhD, Principal investigator, University of British ColumbiaDeborha Jehu, PhD, Principal investigator, University of British ColumbiaPierre Guy, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748354
- Sponsor's protocol ID
- H19-03812
- Status last verified
- Nov 2025
- First submitted
- 1 Feb 2021
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reshaping the Path Post Hip Fracture in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04748354
- Acronym / sponsor ID
- H19-03812
- Conditions
- Hip Fractures, Mild Cognitive Impairment
- Keywords
- Mobility, Exercise, Fall Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 3 May 2021 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 9 May 2024 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Usual care vs. Usual Care with Exercise
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareClinical care provided by geriatricians. Each participant will see the geriatrician at baseline and 6 months. |
| Usual Care with Exercise | Experimental | Behavioral: Otago Exercise Program, Other: Usual CareClinical 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Otago Exercise ProgramAlso: ExerciseAn individualized and home-based program of progressive strength and balance training exercises delivered by a physical therapist | Behavioural | Usual Care with Exercise |
| Usual CareClinical care provided by a geriatrician. | Other | Usual Care, Usual Care with Exercise |
Primary outcome
Change in Physiological Profile Assessment
Time frame: Baseline to 6 Months
A measure of fall risk (z-score).
18 secondary outcomes
Change in Short Physical Performance Battery
Time frame: Baseline to 3 Months and 6 Months
Change in Usual Gait Speed
Time frame: Baseline to 3 Months and 6 Months
Change in Life Space Assessment
Time frame: Baseline to 3 Months and 6 Months
Change in NIH Cognitive Toolbox
Time frame: Baseline to 3 Months and 6 Months
Change in Digit Symbol Substitute Test
Time frame: Baseline to 3 Months and 6 Months
Change in Center for Epidemiological Studies Depression Scale
Time frame: Baseline to 3 Months and 6 Months
Change in Positive and Negative Affect Scale
Time frame: Baseline to 3 Months and 6 Months
Change in EQ-5D-5L
Time frame: Baseline to 3 Months and 6 Months
Change in ICE-CAP
Time frame: Baseline to 3 Months and 6 Months
Change in Physical Activity for the Elderly
Time frame: Monthly from Baseline to 6 Months
Total Number of Prospective Falls
Time frame: Monthly from Baseline to 6 Months
Change in Activities Specific Balance Confidence
Time frame: Baseline to 3 Months and 6 Months
Change in Physiological Profile Assessment
Time frame: Baseline to 3 Months
Change in Timed Up and Go Test
Time frame: Baseline to 3 Months and 6 Months
Change in Fried Frailty
Time frame: Baseline to 3 Months and 6 Months
Change in Clinical Frailty Scale
Time frame: Baseline to 3 Months and 6 Months
Change in Pittsburgh Sleep Quality Index
Time frame: Baseline to 3 Month and 6 Months
Change in Rey Auditory Verbal Learning
Time frame: Baseline to 3 Month and 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otago Exercise Program in people with Hip Fractures and Mild Cognitive Impairment, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physiological Profile Assessment (time frame: Baseline to 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.