Femoral Fractures, Hip Fractures
Conditions
Keywords
exercise, hip fractures, rehabilitation, aged, aged 80 and over
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.
Interventions
OTHERB4 Clinic
Fracture Follow-Up Clinic plus Exercise Program
OTHERUsual Care
Sponsors
Canadian Institutes of Health Research (CIHR)
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| Falls Self-efficacy International (FES-I) | baseline | 16 items, the lower the score the better, e.g., more falls efficacy (range from 7-28) |
| 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 |
| Leg Strength (Fractured Leg) | 12 months | measurement of leg strength using a hand-held 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. |
| Lower Extremity Measure | 12 months | Self reported measure of lower extremity function. Scored 0 to 100. The higher the score the better. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual care following hip fracture
Usual Care | 27 |
| Intervention Follow-up Fracture Clinic
B4 Clinic: Fracture Follow-Up Clinic plus Exercise Program | 26 |
| Total | 53 |
Baseline characteristics
| Characteristic | Usual Care | Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 27 Participants | 26 Participants | 53 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Canada | 27 participants | 26 participants | 53 participants |
| Sex: Female, Male Female | 16 Participants | 18 Participants | 34 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 26 |
| other Total, other adverse events | 0 / 27 | 0 / 26 |
| serious Total, serious adverse events | 0 / 27 | 1 / 26 |
Outcome results
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.
Time frame: 12 months post-fracture
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Short Physical Performance Battery | 8.24 score on a scale | Standard Deviation 2.44 |
| Intervention | Short Physical Performance Battery | 9.08 score on a scale | Standard Deviation 3.03 |
Secondary
Difference in Sedentary Behavior Minutes/Day
difference between groups in minutes of sedentary behavior as captured by accelerometry
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Difference in Sedentary Behavior Minutes/Day | 607 adjusted minutes sedentary behavior/day |
| Intervention | Difference in Sedentary Behavior Minutes/Day | 603 adjusted minutes sedentary behavior/day |
Secondary
Falls
number of self-reported falls over 12 months/group
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Falls | 31 number of falls over 12 months/group |
| Intervention | Falls | 28 number of falls over 12 months/group |
Secondary
Falls Self-efficacy International (FES-I)
16 items, the lower the score the better, e.g., more falls efficacy (range from 7-28)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Falls Self-efficacy International (FES-I) | 12.1 score on a scale | Standard Deviation 5.7 |
| Intervention | Falls Self-efficacy International (FES-I) | 9.8 score on a scale | Standard Deviation 3.1 |
Secondary
Gait Speed (m/s)
measurement of walking speed over 3 or 4 meters
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Gait Speed (m/s) | 0.91 m/s | Standard Deviation 0.47 |
| Intervention | Gait Speed (m/s) | 0.90 m/s | Standard Deviation 0.31 |
Secondary
Grip Strength (Bilateral)
measurement of grip strength using a dynamometer
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Grip Strength (Bilateral) | 25.64 kg | Standard Deviation 11.92 |
| Intervention | Grip Strength (Bilateral) | 26.13 kg | Standard Deviation 10.25 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Health Related Quality of Life (EQ5D-5L) | 78.0 units on a scale | Standard Deviation 15.5 |
| Intervention | Health Related Quality of Life (EQ5D-5L) | 77.2 units on a scale | Standard Deviation 13.9 |
Secondary
Leg Strength (Fractured Leg)
measurement of leg strength using a hand-held dynamometer
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Leg Strength (Fractured Leg) | 19.63 kg | Standard Deviation 7.55 |
| Intervention | Leg Strength (Fractured Leg) | 18.87 kg | Standard Deviation 8.13 |
Secondary
Lower Extremity Measure
Self reported measure of lower extremity function. Scored 0 to 100. The higher the score the better.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Lower Extremity Measure | 82.27 units on a scale | Standard Deviation 14.55 |
| Intervention | Lower Extremity Measure | 88.72 units on a scale | Standard Deviation 9.4 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Quality of Life (ICECAP-O) | 0.81 units on a scale | Standard Deviation 0.11 |
| Intervention | Quality of Life (ICECAP-O) | 0.78 units on a scale | Standard Deviation 0.13 |
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.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Timed up and Go (TUG) | 16.1 seconds | Standard Deviation 10.4 |
| Intervention | Timed up and Go (TUG) | 16.1 seconds | Standard Deviation 9.5 |