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
  Purpose

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.


Condition Intervention
Falls
Behavioral: Home-based balance and strength retraining exercise program.
Behavioral: control; usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: "Action Seniors!: A 12 Month Randomized Controlled Trial of a Home Based Strength and Balance Retraining Program in Reducing Falls.

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Falls over a 12 month period. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 344
Study Start Date: November 2009
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
OEP (Otago Exercise Program; home-based balance and strength retraining program)
Behavioral: Home-based balance and strength retraining exercise program.
A 12-month home-based balance and strength restraining program delivered by a physical therapist
Active Comparator: 2
CON (control; usual care)
Behavioral: control; usual care
Usual care as prescribed by geriatrician.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029171

Contacts
Contact: Jenna Homer 604 875 4111 ext 66459 jenna.homer@hiphealth.ca

Locations
Canada, British Columbia
Centre for Hip Health and Mobility Recruiting
Vancouver, British Columbia, Canada
Contact: Jenna Homer    604 875 4111 ext 66459    jenna.homer@hiphealth.ca   
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
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
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01029171     History of Changes
Other Study ID Numbers: H04-70171
Study First Received: December 7, 2009
Last Updated: March 5, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
falls
balance training
strength training

ClinicalTrials.gov processed this record on April 22, 2014