NCT01254942

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 7, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
9.1 years until next milestone

Results Posted

Study results publicly available

September 25, 2023

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

3.7 years

First QC Date

December 2, 2010

Results QC Date

June 22, 2021

Last Update Submit

September 21, 2023

Conditions

Keywords

exercisehip fracturesrehabilitationagedaged 80 and over

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Difference in Sedentary Behavior Minutes/Day

    12 months

  • Falls

    12 months

  • Quality of Life (ICECAP-O)

    12 months

  • Health Related Quality of Life (EQ5D-5L)

    12 months

  • Lower Extremity Measure

    12 months

  • +5 more secondary outcomes

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Usual care following hip fracture

Other: Usual Care

Intervention

EXPERIMENTAL

Follow-up Fracture Clinic

Other: B4 Clinic

Interventions

Fracture Follow-Up Clinic plus Exercise Program

Intervention
Also known as: usual care pathways for after hip fracture
Usual Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • years +
  • community-dwelling
  • residents of Metro Vancouver
  • recent history (within 12 months) of femoral fracture

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia - VCHRI

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (4)

  • 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.

    PMID: 21651819BACKGROUND
  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Hip FracturesFemoral FracturesMotor Activity

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesBehavior

Results Point of Contact

Title
Associate Professor MC Ashe
Organization
The University Of British Columbia

Study Officials

  • Maureen C. Ashe, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 2, 2010

First Posted

December 7, 2010

Study Start

December 1, 2010

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

September 25, 2023

Results First Posted

September 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations