Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors

Study Overview
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Brief Summary
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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.

Official Title
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Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors

Conditions
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Hip Fractures, Femoral Fractures

Intervention / Treatment
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* Other: B4 Clinic
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Usual care following hip fracture | Other: Usual Care<br> <br> * Other names: usual care pathways for after hip fracture;|
| Experimental: Intervention<br>Follow-up Fracture Clinic | Other: B4 Clinic<br>* Fracture Follow-Up Clinic plus Exercise Program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Sedentary Behavior Minutes/Day | difference between groups in minutes of sedentary behavior as captured by accelerometry | 12 months | 
| Falls | number of self-reported falls over 12 months/group | 12 months | 
| 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 | 
| 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 | 
| Lower Extremity Measure | Self reported measure of lower extremity function. Scored 0 to 100. The higher the score the better. | 12 months | 
| Gait Speed (m/s) | measurement of walking speed over 3 or 4 meters | 12 months | 
| Grip Strength (Bilateral) | measurement of grip strength using a dynamometer | 12 months | 
| Leg Strength (Fractured Leg) | measurement of leg strength using a hand-held dynamometer | 12 months | 
| 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 | 
| Falls Self-efficacy International (FES-I) | 16 items, the lower the score the better, e.g., more falls efficacy (range from 7-28) | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip fractures, rehabilitation, aged, aged 80 and over, exercise