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Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors

This study is currently recruiting participants.
Verified April 2013 by University of British Columbia
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01254942
First received: December 2, 2010
Last updated: April 17, 2013
Last verified: April 2013
History of Changes
  Purpose

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 a exercise program will have significantly improved Short Physical Performance Battery (SPPB) scores compared with participants who receive usual care alone.


Condition Intervention
Hip Fractures
Femoral Fractures
 Other: B4 Clinic
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Short Physical Performance Battery [ Time Frame: 12 months post-fracture ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Gait speed (m/s) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Physical Activity (accelerometry) minutes of time spent in light and MVPA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Sedentary behaviour (accelerometry) minutes and percentage of daily sedentary behaviour [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Health related quality of life (EQ5D-5L) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of Life (ICECAP-O) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Health Resource Utilization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Executive Function (Stroop and Trail B) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Global cognition (MoCA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Leg strength (bilateral) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Falls [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: December 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual Care
Usual care following hip fracture
 Other: Usual Care
Other Name: usual care pathways for after hip fracture
Experimental: Intervention
Follow-up Fracture Clinic
 Other: B4 Clinic
Fracture Follow-Up Clinic plus Exercise Program

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254942

Contacts
Contact: Maureen C. Ashe, PhD 604-675-2573 maureen.ashe@exchange.ubc.ca

Locations
Canada, British Columbia
University of British Columbia - VCHRI Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Maureen C. Ashe, PhD University of British Columbia
  More Information

No publications provided by University of British Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01254942     History of Changes
Other Study ID Numbers: H09-01291
Study First Received: December 2, 2010
Last Updated: April 17, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
exercise
hip fractures
rehabilitation
aged
aged 80 and over

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Hip Fractures
 Wounds and Injuries
Leg Injuries
Hip Injuries

ClinicalTrials.gov processed this record on May 22, 2013