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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Usual care following hip fracture |
|
| Intervention | Experimental | Follow-up Fracture Clinic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B4 Clinic | Other | Fracture Follow-Up Clinic plus Exercise Program |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maureen C. Ashe, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia - VCHRI | Vancouver | British Columbia | V5Z 1M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21651819 | Background | 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. | |
| 33176306 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Usual care following hip fracture provided by the public health care system. this may include publicly funded home care services, rehab, and follow-up visits with doctors. Usual Care |
| FG001 | Intervention | Follow-up Fracture Clinic B4 Clinic: Fracture Follow-Up Clinic plus Exercise Program This is an interdisciplinary outpatient clinic within the public health care system. Participants were assessed by a geriatrician, physiotherapist, occupational therapist, and other health providers as needed. Management and sessions were determined by health providers and participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Usual care following hip fracture Usual Care |
| BG001 | Intervention | Follow-up Fracture Clinic B4 Clinic: Fracture Follow-Up Clinic plus Exercise Program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months post-fracture |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Usual care following hip fracture Usual Care | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Possible adverse event | Musculoskeletal and connective tissue disorders | Systematic Assessment | There was one serious adverse event (intervention group) that was possibly related to the intervention, but no follow-up action was required. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Professor MC Ashe | The University Of British Columbia | 604-675-2574 | maureen.ashe@ubc.ca |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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| Usual Care |
| Other |
|
|
| 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 |
| 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. |
| 38185111 | Derived | Ashe MC, Grover S, Bryan S, Cook WL, Donaldson MG, Brasher PMA. Perceived Health Status and Capability after Hip Fracture: Secondary Outcomes from an Randomized Controlled Trial. Gerontology. 2024;70(3):235-240. doi: 10.1159/000536131. Epub 2024 Jan 5. |
| 34766330 | Derived | Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Difference in Sedentary Behavior Minutes/Day | difference between groups in minutes of sedentary behavior as captured by accelerometry | Posted | Number | adjusted minutes sedentary behavior/day | 12 months |
|
|
|
| Secondary | Falls | number of self-reported falls over 12 months/group | Posted | Number | number of 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. | Posted | Mean | Standard Deviation | units on a scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | Lower Extremity Measure | Self reported measure of lower extremity function. Scored 0 to 100. The higher the score the better. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | Gait Speed (m/s) | measurement of walking speed over 3 or 4 meters | Posted | Mean | Standard Deviation | m/s | 12 months |
|
|
|
| Secondary | Grip Strength (Bilateral) | measurement of grip strength using a dynamometer | Posted | Mean | Standard Deviation | kg | 12 months |
|
|
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| Secondary | Leg Strength (Fractured Leg) | measurement of leg strength using a hand-held dynamometer | Posted | Mean | Standard Deviation | kg | 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. | Posted | Mean | Standard Deviation | seconds | baseline |
|
|
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| Secondary | Falls Self-efficacy International (FES-I) | 16 items, the lower the score the better, e.g., more falls efficacy (range from 7-28) | Posted | Mean | Standard Deviation | score on a scale | baseline |
|
|
|
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Intervention | Follow-up Fracture Clinic B4 Clinic: Fracture Follow-Up Clinic plus Exercise Program | 0 | 26 | 1 | 26 | 0 | 26 |
|
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| D001519 |
| Behavior |