Reducing Fall Risk Post Hip Fracture in Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

Reshaping the Path Post Hip Fracture in Mild Cognitive Impairment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04748354
• Other study ID #: H19-03812
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2024
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Fractures, Bone
• Hip Fractures
• Mild Cognitive Impairment

Intervention

Behavioral:
• Otago Exercise Program
An individualized and home-based program of progressive strength and balance training exercises delivered by a physical therapist

Other:
• Usual Care
Clinical care provided by a geriatrician.

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Amgen

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Physiological Profile Assessment	A measure of fall risk (z-score).	Baseline to 6 Months
Secondary	Change in Short Physical Performance Battery	A measure of balance and mobility (out of 12 points).	Baseline to 3 Months and 6 Months
Secondary	Change in Usual Gait Speed	Gait speed over 4 meters (m/s).	Baseline to 3 Months and 6 Months
Secondary	Change in Life Space Assessment	Mobility within a life-space level.	Baseline to 3 Months and 6 Months
Secondary	Change in NIH Cognitive Toolbox	Cognitive performance of executive functions.	Baseline to 3 Months and 6 Months
Secondary	Change in Digit Symbol Substitute Test	Cognitive performance of processing speed.	Baseline to 3 Months and 6 Months
Secondary	Change in Center for Epidemiological Studies Depression Scale	Mood	Baseline to 3 Months and 6 Months
Secondary	Change in Positive and Negative Affect Scale	Mood	Baseline to 3 Months and 6 Months
Secondary	Change in EQ-5D-5L	Quality of Life	Baseline to 3 Months and 6 Months
Secondary	Change in ICE-CAP	Wellbeing	Baseline to 3 Months and 6 Months
Secondary	Change in Physical Activity for the Elderly	Physical activity over the last 7 days	Monthly from Baseline to 6 Months
Secondary	Total Number of Prospective Falls	Self-report of falls using calendars	Monthly from Baseline to 6 Months
Secondary	Change in Activities Specific Balance Confidence	Fall-related self efficacy	Baseline to 3 Months and 6 Months
Secondary	Change in Physiological Profile Assessment	A measure of fall risk (z-score); higher z scores indicate higher risk of falls.	Baseline to 3 Months
Secondary	Change in Timed Up and Go Test	A measure of functional mobility; greater time for completion indicate poorer performance.	Baseline to 3 Months and 6 Months
Secondary	Change in Fried Frailty	A measure of physical frailty	Baseline to 3 Months and 6 Months
Secondary	Change in Pittsburgh Sleep Quality Index	A measure of subjective sleep quality	Baseline to 3 Month and 6 Months
Secondary	Change in Rey Auditory Verbal Learning	A measure of episodic memory; higher scores indicate bettter episodic performance.	Baseline to 3 Month and 6 Months