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Completed

NCT Number: NCT01254942

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.

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Key information

Conditions

Hip Fractures Behavior Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Motor Activity Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia - VCHRI

Vancouver, British Columbia, V5Z 1M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

B4 Clinic

Other

Fracture Follow-Up Clinic plus Exercise Program

Usual Care

Other

Other names: usual care pathways for after hip fracture

Primary outcomes

  1. Short Physical Performance Battery

    Time frame: 12 months post-fracture

    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 outcomes

  1. Difference in Sedentary Behavior Minutes/Day

    Time frame: 12 months

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

  2. Falls

    Time frame: 12 months

    number of self-reported falls over 12 months/group

  3. Quality of Life (ICECAP-O)

    Time frame: 12 months

    self-reported quality of life measure, scores range from 0 to 1 (0 = no capability, 1 = full capability); the higher the score the better.

  4. Health Related Quality of Life (EQ5D-5L)

    Time frame: 12 months

    self-reported health related quality of life (Visual Analogue Scale, 0 to 100). The higher the score means a better outcome.

  5. Lower Extremity Measure

    Time frame: 12 months

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

  6. Gait Speed (m/s)

    Time frame: 12 months

    measurement of walking speed over 3 or 4 meters

  7. Grip Strength (Bilateral)

    Time frame: 12 months

    measurement of grip strength using a dynamometer

  8. Leg Strength (Fractured Leg)

    Time frame: 12 months

    measurement of leg strength using a hand-held dynamometer

  9. Timed up and Go (TUG)

    Time frame: baseline

    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.

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

    Time frame: baseline

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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 7, 2010
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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