Action Seniors! Exercise to Prevent Falls

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 8, 2014
Last verified: September 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
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, see Learn About Clinical Studies.

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: September 8, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 11, 2014