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Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors

Primary Purpose

Hip Fractures, Femoral Fractures

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
B4 Clinic
Usual Care
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hip Fractures focused on measuring exercise, hip fractures, rehabilitation, aged, aged 80 and over

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • University of British Columbia - VCHRI

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care

Intervention

Arm Description

Usual care following hip fracture

Follow-up Fracture Clinic

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 2, 2010
Last Updated
September 21, 2023
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01254942
Brief Title
Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors
Official Title
Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Femoral Fractures
Keywords
exercise, hip fractures, rehabilitation, aged, aged 80 and over

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual care following hip fracture
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Follow-up Fracture Clinic
Intervention Type
Other
Intervention Name(s)
B4 Clinic
Intervention Description
Fracture Follow-Up Clinic plus Exercise Program
Intervention Type
Other
Intervention Name(s)
Usual Care
Other Intervention Name(s)
usual care pathways for after hip fracture
Primary Outcome Measure Information:
Title
Short Physical Performance Battery
Description
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
Secondary Outcome Measure Information:
Title
Difference in Sedentary Behavior Minutes/Day
Description
difference between groups in minutes of sedentary behavior as captured by accelerometry
Time Frame
12 months
Title
Falls
Description
number of self-reported falls over 12 months/group
Time Frame
12 months
Title
Quality of Life (ICECAP-O)
Description
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
Title
Health Related Quality of Life (EQ5D-5L)
Description
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
Title
Lower Extremity Measure
Description
Self reported measure of lower extremity function. Scored 0 to 100. The higher the score the better.
Time Frame
12 months
Title
Gait Speed (m/s)
Description
measurement of walking speed over 3 or 4 meters
Time Frame
12 months
Title
Grip Strength (Bilateral)
Description
measurement of grip strength using a dynamometer
Time Frame
12 months
Title
Leg Strength (Fractured Leg)
Description
measurement of leg strength using a hand-held dynamometer
Time Frame
12 months
Title
Timed up and Go (TUG)
Description
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
Title
Falls Self-efficacy International (FES-I)
Description
16 items, the lower the score the better, e.g., more falls efficacy (range from 7-28)
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen C. Ashe, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia - VCHRI
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21651819
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.
Results Reference
background
PubMed Identifier
33176306
Citation
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.
Results Reference
result
PubMed Identifier
34766330
Citation
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.
Results Reference
derived

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Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors

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