Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors

Hip Fractures Clinical Trial

Official title:

Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254942
• Other study ID #: H09-01291
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: September 2014

Study information

• Verified date: September 2023
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a parallel Randomized Controlled Trial comparing two different delivery modes of post hip fracture management-a specialized Fracture Follow-up Clinic versus Usual Care alone. The Fracture Follow-up Clinic will focus on bone health and fall risk factors. The investigators will evaluate the effect of the clinic and exercise program on mobility and falls. The investigators primary hypothesis is that within the first year following a hip fracture, older adults who are assessed in the B4 Clinic and prescribed an exercise program will have significantly improved Short Physical Performance Battery (SPPB) scores compared with participants who receive usual care alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 65 years +
• community-dwelling
• residents of Metro Vancouver
• recent history (within 12 months) of femoral fracture

Exclusion Criteria:

• unable to ambulate 10 meters prior to the femoral fracture were(with/without a walking aid)
• discharged to a residential care facility
• and/or diagnosed with any type of dementia (Alzheimer's, vascular etc.)

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Hip Fractures

Intervention

Other:
• B4 Clinic
Fracture Follow-Up Clinic plus Exercise Program
• Usual Care

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Cook WL, Brasher PMA, Guy P, Bryan S, Donaldson MG, Sims-Gould J, McKay HA, Khan KM, Ashe MC. Comprehensive Geriatric Care to Improve Mobility after Hip Fracture: An RCT. Gerontology. 2020;66(6):542-548. doi: 10.1159/000510903. Epub 2020 Nov 11. — View Citation

Cook WL, Khan KM, Bech MH, Brasher PM, Brown RA, Bryan S, Donaldson MG, Guy P, Hanson HM, Leia C, Macri EM, Sims-Gould J, McKay HA, Ashe MC. Post-discharge management following hip fracture--get you back to B4: a parallel group, randomized controlled trial study protocol. BMC Geriatr. 2011 Jun 9;11:30. doi: 10.1186/1471-2318-11-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Physical Performance Battery	The primary outcome for this trial is the Short Physical Performance Battery (SPPB). The SPPB is composed of three separate tests that are timed and categorized depending on performance. The three domains evaluated in the SPPB are standing balance, gait speed, and sit to stand performance.; The SPPB scores can range from 0-12, a higher score indicates better performance. The subscales are combined.	12 months post-fracture
Secondary	Difference in Sedentary Behavior Minutes/Day	difference between groups in minutes of sedentary behavior as captured by accelerometry	12 months
Secondary	Falls	number of self-reported falls over 12 months/group	12 months
Secondary	Quality of Life (ICECAP-O)	self-reported quality of life measure, scores range from 0 to 1 (0 = no capability, 1 = full capability); the higher the score the better.	12 months
Secondary	Health Related Quality of Life (EQ5D-5L)	self-reported health related quality of life (Visual Analogue Scale, 0 to 100). The higher the score means a better outcome.	12 months
Secondary	Lower Extremity Measure	Self reported measure of lower extremity function. Scored 0 to 100. The higher the score the better.	12 months
Secondary	Gait Speed (m/s)	measurement of walking speed over 3 or 4 meters	12 months
Secondary	Grip Strength (Bilateral)	measurement of grip strength using a dynamometer	12 months
Secondary	Leg Strength (Fractured Leg)	measurement of leg strength using a hand-held dynamometer	12 months
Secondary	Timed up and Go (TUG)	Measure of global mobility, reported in s. Participant is asked to rise from a chair, walk 3 meters, turn and walk back to chair and sit down.	baseline
Secondary	Falls Self-efficacy International (FES-I)	16 items, the lower the score the better, e.g., more falls efficacy (range from 7-28)	baseline