Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01254942
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : May 16, 2017
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Maureen C. Ashe, University of British Columbia

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Hip Fractures Femoral Fractures Other: B4 Clinic Other: Usual Care Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors
Study Start Date : December 2010
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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.


Secondary Outcome Measures :
  1. Sedentary behaviour (accelerometry) minutes and percentage of daily sedentary behaviour [ Time Frame: 12 months ]
  2. Physical Activity (accelerometry) minutes of time spent in light and MVPA [ Time Frame: 12 months ]
  3. Global cognition (MoCA) [ Time Frame: 12 months ]
  4. Executive Function (Stroop and Trail B) [ Time Frame: 12 months ]
  5. Falls [ Time Frame: 12 months ]
  6. Quality of Life (ICECAP-O) [ Time Frame: 12 months ]
  7. Health related quality of life (EQ5D-5L) [ Time Frame: 12 months ]
  8. Health Resource Utilization [ Time Frame: 12 months ]
  9. Lower Extremity Measure [ Time Frame: 12 months ]
  10. Gait speed (m/s) [ Time Frame: 12 months ]
  11. Grip strength (bilateral) [ Time Frame: 12 months ]
  12. Leg strength (bilateral) [ Time Frame: 12 months ]
  13. Timed up and Go (TUG) [ Time Frame: 12 months ]
  14. Falls Self-efficacy International (FES-I) [ Time Frame: 12 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254942


Locations
Layout table for location information
Canada, British Columbia
University of British Columbia - VCHRI
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Layout table for investigator information
Principal Investigator: Maureen C. Ashe, PhD University of British Columbia
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Maureen C. Ashe, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01254942    
Other Study ID Numbers: H09-01291
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Maureen C. Ashe, University of British Columbia:
exercise
hip fractures
rehabilitation
aged
aged 80 and over
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Hip Fractures
Femoral Fractures
 Wounds and Injuries
Hip Injuries
Leg Injuries