Clinical trial NCT04748354: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Mild Cognitive Impairment
Keywords: Mobility
Exercise
Fall Risk
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2021-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Usual care vs. Usual Care with Exercise
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Change in Physiological Profile Assessment
timeFrame: Baseline to 6 Months
Secondary outcomes:
measure: Change in Short Physical Performance Battery
timeFrame: Baseline to 3 Months and 6 Months
measure: Change in Usual Gait Speed
timeFrame: Baseline to 3 Months and 6 Months
measure: Change in Life Space Assessment
timeFrame: Baseline to 3 Months and 6 Months
measure: Change in NIH Cognitive Toolbox
timeFrame: Baseline to 3 Months and 6 Months
measure: Change in Digit Symbol Substitute Test
timeFrame: Baseline to 3 Months and 6 Months
measure: Change in Center for Epidemiological Studies Depression Scale
timeFrame: Baseline to 3 Months and 6 Months
measure: Change in Positive and Negative Affect Scale
timeFrame: Baseline to 3 Months and 6 Months
measure: Change in EQ-5D-5L
timeFrame: Baseline to 3 Months and 6 Months
measure: Change in ICE-CAP
timeFrame: Baseline to 3 Months and 6 Months
measure: Change in Physical Activity for the Elderly
timeFrame: Monthly from Baseline to 6 Months
measure: Total Number of Prospective Falls
timeFrame: Monthly from Baseline to 6 Months
measure: Change in Activities Specific Balance Confidence
timeFrame: Baseline to 3 Months and 6 Months
measure: Change in Physiological Profile Assessment
timeFrame: Baseline to 3 Months
measure: Change in Timed Up and Go Test
timeFrame: Baseline to 3 Months and 6 Months
measure: Change in Fried Frailty
timeFrame: Baseline to 3 Months and 6 Months
measure: Change in Clinical Frailty Scale
timeFrame: Baseline to 3 Months and 6 Months
measure: Change in Pittsburgh Sleep Quality Index
timeFrame: Baseline to 3 Month and 6 Months
measure: Change in Rey Auditory Verbal Learning
timeFrame: Baseline to 3 Month and 6 Months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Teresa Liu-Ambrose, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Larry Dian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Jennifer C Davis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Deborha Jehu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Pierre Guy, MD
role: PRINCIPAL_INVESTIGATOR
References: