Action Seniors! Exercise to Prevent Falls

This study is currently recruiting participants.
Verified March 2014 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:
NCT01029171
First received: December 7, 2009
Last updated: March 5, 2014
Last verified: March 2014

December 7, 2009
March 5, 2014
November 2009
December 2014   (final data collection date for primary outcome measure)
Falls over a 12 month period. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01029171 on ClinicalTrials.gov Archive Site
Secondary outcomes of interest include: 1) physiological falls risk; 2) mobility; 3) cognitive function; and 4) economic evaluation. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Action Seniors! Exercise to Prevent Falls
"Action Seniors!: A 12 Month Randomized Controlled Trial of a Home Based Strength and Balance Retraining Program in Reducing Falls.

This study will be a randomized controlled trial to determine the efficacy of the Otago Exercise Program (OEP) on falls among seniors with a history of falls.

A total of 344 community-dwelling adults aged 70 years and older who are referred to a falls clinic secondary to seeking medical attention due to a fall will be randomized to either the 12-month OEP group or usual care. There will be three measurement sessions: baseline, 6 months, and 12 months.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Falls
  • Behavioral: Home-based balance and strength retraining exercise program.
    A 12-month home-based balance and strength restraining program delivered by a physical therapist
  • Behavioral: control; usual care
    Usual care as prescribed by geriatrician.
  • Experimental: 1
    OEP (Otago Exercise Program; home-based balance and strength retraining program)
    Intervention: Behavioral: Home-based balance and strength retraining exercise program.
  • Active Comparator: 2
    CON (control; usual care)
    Intervention: Behavioral: control; usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
344
July 2016
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Adults older than or 70 years attending a Falls Prevention Clinic Service;
  2. Understands, speaks, and reads English proficiently;
  3. MMSE 8 score > 24/30;
  4. Had one documented non-syncopal fall in the last 12 months and one of the following: a) A Physiological Profile Assessment (PPA) score of at least 1 SD above normal; OR 2) Timed Up and Go Test (TUG) performance of greater than 15 seconds; OR 3) One additional documented non-syncopal fall in the previous 12 months;
  5. Expected to live greater than 12 months;
  6. Community-dwelling (i.e., not residing in a nursing home, extended care unit, or assisted-care facility);
  7. Able to walk 3 meters with or without an assistive device; and
  8. Able to provide written informed consent.

Exclusion Criteria:

  1. Diagnosed with a neurodegenerative disease (e.g., Parkinson's disease);
  2. Diagnosed with dementia (of any type);
  3. Had a stroke;
  4. Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease; or
  5. Have a history indicative of carotid sinus sensitivity (i.e., syncopal falls).
Both
70 Years and older
Yes
Contact: Jenna Homer 604 875 4111 ext 66459 jenna.homer@hiphealth.ca
Canada
 
NCT01029171
H04-70171
Yes
University of British Columbia
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Teresa Liu-Ambrose University of British Columbia
Study Director: Karim Khan, Ph.D University of British Columbia
Study Director: Meghan Donaldson, Ph.D University of British Columbia
Study Director: Wendy Cook, Ph.D University of British Columbia
Study Director: Penny Brasher, Ph.D University of British Columbia
Study Director: Carlo Marra, Ph.D University of British Columbia
Study Director: Jennifer Davis, Ph.D University of British Columbia
University of British Columbia
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP