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Hip FracturesNCT01254942

Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors

A study testing B4 Clinic in people with Hip Fractures and Femoral Fractures, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Hip Fractures, Femoral Fractures
What is being tested?
B4 Clinic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteCanada
Study dates
Dec 2010to Sep 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

  • 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.)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of British Columbia - VCHRI

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

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.

Being tested
B4 Clinic, Usual Care
Keywords
exercise, hip fractures, rehabilitation, aged, aged 80 and over
Medical subject headings
Hip Fractures, Femoral Fractures, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • B4 ClinicOther

    Fracture Follow-Up Clinic plus Exercise Program

  • Usual CareOther

    Also called usual care pathways for after hip fracture

Study groups in NCT01254942
Study groupRoleWhat they receive
Usual CareActive comparatorUsual care following hip fracture
Receives: Other: Usual Care
InterventionExperimentalFollow-up Fracture Clinic
Receives: Other: B4 Clinic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months post-fracture

Secondary outcomes (10)

  1. Difference in Sedentary Behavior Minutes/Day

    difference between groups in minutes of sedentary behavior as captured by accelerometry

    Measured: 12 months

  2. Falls

    number of self-reported falls over 12 months/group

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. 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.

    Measured: 12 months

  5. Lower Extremity Measure

    Self reported measure of lower extremity function. Scored 0 to 100. The higher the score the better.

    Measured: 12 months

  6. Gait Speed (m/s)

    measurement of walking speed over 3 or 4 meters

    Measured: 12 months

  7. Grip Strength (Bilateral)

    measurement of grip strength using a dynamometer

    Measured: 12 months

  8. Leg Strength (Fractured Leg)

    measurement of leg strength using a hand-held dynamometer

    Measured: 12 months

  9. 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.

    Measured: baseline

  10. Falls Self-efficacy International (FES-I)

    16 items, the lower the score the better, e.g., more falls efficacy (range from 7-28)

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionAug 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01254942
Sponsor's protocol ID
H09-01291
Status last verified
Sep 2023
First submitted
2 Dec 2010
Last updated
25 Sep 2023
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21651819

  • 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.

    PubMed 33176306

  • 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.

    PubMed 38185111

  • 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.

    PubMed 34766330

Questions about this trial

What is this clinical trial studying?

A study testing B4 Clinic in people with Hip Fractures and Femoral Fractures, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short Physical Performance Battery (time frame: 12 months post-fracture). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01254942, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.

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