Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors

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.

Study Overview

• Status: Completed
• Conditions: Femoral Fractures; Hip Fractures
• Intervention / Treatment: Other: Usual Care; Other: B4 Clinic

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • University of British Columbia - VCHRI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Maureen C. Ashe, PhD, University of British Columbia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: December 2, 2010
• First Submitted That Met QC Criteria: December 3, 2010
• First Posted (Estimated): December 7, 2010

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: exercise; rehabilitation; aged; hip fractures; aged 80 and over
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Hip Injuries; Femoral Fractures; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: H09-01291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO