Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors

Not Applicable

Completed

• Conditions: Hip Fractures; Femoral Fractures
• Interventions: Other: B4 Clinic; Other: Usual Care

• Registration Number: NCT01254942
• Lead Sponsor: University of British Columbia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2010-12-03
• Study First Posted: 2010-12-07
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Results First Submitted: 2021-06-22
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-21
• Last Update Submitted: 2023-09-21
• Results First Posted: 2023-09-25
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

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

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	B4 Clinic	Follow-up Fracture Clinic
Usual Care	Usual Care	Usual care following hip fracture

Primary Outcome Measures

Name	Time	Method
Short Physical Performance Battery	12 months post-fracture	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life (ICECAP-O)	12 months	self-reported quality of life measure, scores range from 0 to 1 (0 = no capability, 1 = full capability); the higher the score the better.
Lower Extremity Measure	12 months	Self reported measure of lower extremity function. Scored 0 to 100. The higher the score the better.
Difference in Sedentary Behavior Minutes/Day	12 months	difference between groups in minutes of sedentary behavior as captured by accelerometry
Falls	12 months	number of self-reported falls over 12 months/group
Gait Speed (m/s)	12 months	measurement of walking speed over 3 or 4 meters
Grip Strength (Bilateral)	12 months	measurement of grip strength using a dynamometer
Timed up and Go (TUG)	baseline	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.
Health Related Quality of Life (EQ5D-5L)	12 months	self-reported health related quality of life (Visual Analogue Scale, 0 to 100). The higher the score means a better outcome.
Leg Strength (Fractured Leg)	12 months	measurement of leg strength using a hand-held dynamometer
Falls Self-efficacy International (FES-I)	baseline	16 items, the lower the score the better, e.g., more falls efficacy (range from 7-28)

Trial Locations

Locations (1)

University of British Columbia - VCHRI; 🇨🇦 Vancouver, British Columbia, Canada